Comparison of 0.05% cyclosporine and 3% diquafosol solution for dry eye patients: A randomized, blinded, multicenter clinical trial

Abstract Background This study is aim to compare the clinical effectiveness between the two most prominent dry eye disease (DED)-specific eye drops, 0.05% cyclosporine (CN) and 3% diquafosol (DQ). Methods This is a multi-centered, randomized, masked, prospective clinical study. A total of 227 eyes from 227 DED patients were randomly allocated to use CN twice per day or DQ six times daily. Cornea and conjunctival staining scores (NEI scale), tear break-up time (TBUT), Schirmer test scores, and ocular surface disease index (OSDI) score were measured at baseline, 4 and 12 weeks after treatment. Results At 12 weeks after treatment, NEI scaled scores were reduced from the baseline by -6.60 for CN and -6.63 for DQ group (P=0.9739 between groups). TBUT and Schirmer values for CN were significantly improved from the baseline at 4 and 12 weeks (P< 0.0001). However, for DQ, TBUT showed significant improvement at week 12 only (P=0.0281). Mean OSDI score differences from the baseline to 12 weeks were -13.03±19.63 in CN and -16.11±20.87 in DQ, respectively (P=0.854 between groups). Regarding drug compliance, the mean instillation frequency of CN was lesser than that of DQ (P<0.001). Conclusions The level of improvement regarding NEI, TBUT, and OSDI scores were not significantly different between the two treatment groups. However, with regards to the early improvement of TBUT and patient compliance, patients using CN improved faster and with greater adherence to drug usage than did those treated with DQ. Trial registration: KCT0002180, Registered 23 December 2016 (retrospectively registered)

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Comparison of 0.05% cyclosporine and 3% diquafosol solution for dry eye patients: A randomized, blinded, multicenter clinical trial

10.21203/rs.2.487/v2 ◽

2019 ◽

Author(s):

Chang Hyun Park ◽

Hyung Keun Lee ◽

Mee Kum Kim ◽

Eun Chul Kim ◽

Jae Yong Kim ◽

...

Keyword(s):

Dry Eye ◽

Safety Evaluation ◽

Clinical Effectiveness ◽

Prospective Clinical Study ◽

Eye Drops ◽

Schirmer Test ◽

Ocular Surface Disease Index ◽

Drug Usage ◽

Early Improvement ◽

Treatment Groups

Abstract Background This study is aim to compare the clinical effectiveness between the two most prominent dry eye disease (DED)-specific eye drops, 0.05% cyclosporine (CN) and 3% diquafosol (DQ). Methods This is a multi-centered, randomized, masked, prospective clinical study. A total of 153 DED patients were randomly allocated to use CN twice per day or DQ six times daily. Cornea and conjunctival staining scores (NEI scale), tear break-up time (TBUT), Schirmer test scores, and ocular surface disease index (OSDI) score were measured at baseline, 4 and 12 weeks after treatment. Results At 12 weeks after treatment, NEI scaled scores were significantly reduced from the baseline by -6.60 for CN and -6.63 for DQ group (all P<0.0001, P=0.9739 between groups). TBUT and Schirmer values for CN were significantly improved from the baseline at 4 and 12 weeks (P=0.0034, P<0.0001 for TBUT, P=0.0418, P=0.0031 for Schirmer test). However, for DQ, TBUT showed significant improvement at 12 weeks only (P=0.0281). Mean OSDI score differences from the baseline to 12 weeks were improved by -13.03±19.63 for CN and -16.11±20.87 for DQ, respectively (all P<0.0001, P=0.854 between groups). Regarding drug compliance, the mean instillation frequency of CN was less than that of DQ (P<0.001). There were no statistically significant intergroup differences in safety evaluation. Conclusions The level of improvement regarding NEI, TBUT, and OSDI scores were not significantly different between the two treatment groups. However, with regards to the early improvement of TBUT and patient compliance, patients using CN improved faster and with greater adherence to drug usage than did those treated with DQ.

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Comparison of 0.05% cyclosporine and 3% diquafosol solution for dry eye patients: A randomized, blinded, multicenter clinical trial

10.21203/rs.2.487/v3 ◽

2019 ◽

Author(s):

Chang Hyun Park ◽

Hyung Keun Lee ◽

Mee Kum Kim ◽

Eun Chul Kim ◽

Jae Yong Kim ◽

...

Keyword(s):

Dry Eye ◽

Safety Evaluation ◽

Clinical Effectiveness ◽

Prospective Clinical Study ◽

Eye Drops ◽

Schirmer Test ◽

Ocular Surface Disease Index ◽

Drug Usage ◽

Early Improvement ◽

Treatment Groups

Abstract Background This study is aim to compare the clinical effectiveness between the two most prominent dry eye disease (DED)-specific eye drops, 0.05% cyclosporine (CN) and 3% diquafosol (DQ). Methods This is a multi-centered, randomized, masked, prospective clinical study. A total of 153 DED patients were randomly allocated to use CN twice per day or DQ six times daily. Cornea and conjunctival staining scores (NEI scale), tear break-up time (TBUT), Schirmer test scores, and ocular surface disease index (OSDI) score were measured at baseline, 4 and 12 weeks after treatment. Results At 12 weeks after treatment, NEI scaled scores were significantly reduced from the baseline by -6.60 for CN and -6.63 for DQ group (all P<0.0001, P=0.9739 between groups). TBUT and Schirmer values for CN were significantly improved from the baseline at 4 and 12 weeks (P=0.0034, P<0.0001 for TBUT, P=0.0418, P=0.0031 for Schirmer test). However, for DQ, TBUT showed significant improvement at 12 weeks only (P=0.0281). Mean OSDI score differences from the baseline to 12 weeks were improved by -13.03±19.63 for CN and -16.11±20.87 for DQ, respectively (all P<0.0001, P=0.854 between groups). Regarding drug compliance, the mean instillation frequency of CN was less than that of DQ (P<0.001). There were no statistically significant intergroup differences in safety evaluation. Conclusions The level of improvement regarding NEI, TBUT, and OSDI scores were not significantly different between the two treatment groups. However, with regards to the early improvement of TBUT and patient compliance, patients using CN improved faster and with greater adherence to drug usage than did those treated with DQ.

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Use of Plasma Rich in Growth Factors and ReGeneraTing Agent Matrix for the Treatment of Corneal Diseases

Vision ◽

10.3390/vision5030034 ◽

2021 ◽

Vol 5 (3) ◽

pp. 34

Author(s):

Ronald M. Sánchez-Ávila ◽

Edmar Uribe-Badillo ◽

Carlos Fernández-Vega González ◽

Francisco Muruzabal ◽

Borja de la Sen-Corcuera ◽

...

Keyword(s):

Growth Factors ◽

Corneal Ulcer ◽

Disease Index ◽

Eye Drops ◽

Analog Scale ◽

Ocular Surface Disease Index ◽

Corneal Ulcers ◽

Corrected Visual Acuity ◽

The Mean

This study aimed to investigate the use of Plasma Rich in Growth Factors (PRGF) associated with tissue ReGeneraTing Agent (RGTA) drops for the treatment of noninfectious corneal ulcers. RGTA treatment was applied (one drop every two days); however, if ulcer closure was not achieved, PRGF eye drops treatment was added (four times/day). The time taken to reach the ulcer closure, the Best Corrected Visual Acuity (BCVA), intraocular pressure (IOP), Visual Analog Scale (VAS, in terms of frequency and severity of symptoms), and Ocular Surface Disease Index (OSDI) were evaluated. Seventy-four patients (79 eyes) were included, and the mean age was 56.8 ± 17.3 years. The neurotrophic corneal ulcer was the most frequent disorder (n = 27, 34.2%), mainly for herpes virus (n = 15, 19.0%). The time of PRGF eye drops treatment associated with the RGTA matrix was 4.2 ± 2.2 (1.5–9.0) months, and the follow-up period was 44.9 ± 31.5 months. The ulcer closure was achieved in 76 eyes (96.2%). BCVA, VAS and OSDI improved from the baseline (p < 0.001), and IOP remained unchanged (p = 0.665). RGTA and PRGF in noninfectious ulcers were effective and could be a therapeutic alternative for this type of corneal disease.

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Dry eye disease among Glaucoma patients on topical hypotensive medications, in a tertiary hospital, Ethiopia

BMC Ophthalmology ◽

10.1186/s12886-021-01917-3 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Miraf Sahlu ◽

Abeba T. Giorgis

Keyword(s):

Dry Eye ◽

Ocular Surface ◽

Signs And Symptoms ◽

Dry Eye Disease ◽

Eye Disease ◽

Eye Drops ◽

Schirmer Test ◽

Ocular Surface Disease Index ◽

Cross Sectional ◽

Corneal Staining

Abstract Background Dry eye disease is a multifactorial disease; causing various ocular symptoms with potential damage to the ocular surface. Applying hypotensive eye drops are presumed to initiate or exacerbate existing dry eye disease. The purpose of this study was to determine the frequency of signs and symptoms and severity of dry eye disease among glaucoma patients on topical hypotensive medications and controls. Methods A cross-sectional comparative study, involving 320 glaucoma patients and controls. Ocular Surface Disease Index (OSDI) symptoms score and Schirmer, tear breakup time and corneal staining tests were used to assess dry eye disease. Data was analyzed using SPSS version 24 software; p-value less than 0.05 was considered as statistically significant. Results Among the 160 study glaucoma patients, the mean duration of topical hypotensive medication use was 5.2 ± 5.21 years (range, 4 months - 32 years). Mild to severe level of OSDI score was found in 122 (76%) glaucoma patients and in 137 (86%) controls (p = 0.033). Mild to sever abnormal clinical tests in the glaucoma patients and control, respectively, were 106 (66%) vs 80 (50%) corneal staining (p = 0.045), 79 (49%) vs 72 (45%) TBUT (p = 0.021), and 91 (57%) vs 83 (52%) Schirmer test (p = 0.242). Test results at the level of sever: 2 (1%) vs 0 (0%) corneal staining, 50 (31%) vs 39 (24%) TBUT and 65 (41%) vs 60 (38%) Schirmer test in the glaucoma patents and controls, respectively. Corneal staining and TBUT had correlation with the number of drugs (p = 0.004 and 0.031, respectively), and more relationship of the two tests with total number of drops applied per day (p = 0.01 and p < 0.001, respectively). Patients on pilocarpine and timolol had more corneal staining and lower TBUT [(p = 0.011 and p < 0.001) and (p = 0.04 and 0.012), respectively]. Conclusions The study has identified glaucoma patients to be more affected by dry eye disease than non-glaucoma patients, and presence of significantly lower TBUT and higher corneal staining in the glaucoma patients on multidrops and multidose per day. We recommend consideration of evaluation and management of DED for glaucoma patients on multidrops and multidose hypotensive medications.

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Treatment of Noninfectious Corneal Disorders With Plasma Rich in Growth Factors and ReGenerating Agent Matrix

10.21203/rs.3.rs-49518/v1 ◽

2020 ◽

Author(s):

Ronald Mauricio Sanchez-Avila ◽

Edmar Uribe-Badillo ◽

Carlos Fernandez-Vega Gonzalez ◽

Francisco Muruzabal ◽

Borja De la Sen Corcuera ◽

...

Keyword(s):

Growth Factors ◽

Adverse Events ◽

Corneal Ulcer ◽

Eye Drops ◽

Ocular Surface Disease Index ◽

Corneal Ulcers ◽

Corrected Visual Acuity ◽

The Mean ◽

Mean Time

Abstract Background: To provide the efficacy and safety of Plasma Rich in Growth Factors (PRGF) associated with tissue ReGeneraTing Agent (RGTA) drops for the treatment of noninfectious corneal ulcers.Methods: This retrospective study included patients from Fernandez-Vega University Institute between 2010 and 2019, with noninfectious corneal ulcers and no response to standard treatments. RGTA treatment was firstly applied (1 drop every two days), but if ulcer closure was not achieved, PRGF eye drops treatment was added (4 times/day). The time to reach the ulcer closure; the Best Corrected Visual Acuity (BCVA), intraocular pressure (IOP), Visual Analog Scale (VAS, in frequency and severity of symptoms), and Ocular Surface Disease Index (OSDI) were evaluated. The presence of adverse events along the follow-up period was also reported. Results: Seventy-four patients (79 eyes) were included in the study, forty-six eyes (62.2%) were women, and the mean age was 56.8 ± 17.3 years. The neurotrophic corneal ulcer was the most frequent disorder found in the patients of the study (n = 27, 34.2%), mainly due to the herpes virus (n = 15, 19.0%). The mean time of PRGF eye drops treatment associated with RGTA matrix was 4.2 ± 2.2 (1.5 -9.0) months, and the follow-up period was 44.9 ± 31.5 months. The ulcer closure was achieved in 76 eyes (96.2%). BCVA, VAS and OSDI improved significantly from the baseline (p<0.001), while IOP remained unchanged (p=0.665). No adverse events were recorded. Conclusions: The use of RGTA and PRGF in noninfectious ulcers was effective and safe, and it could be a therapeutic alternative for this type of corneal diseases.

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The effect of tamarind seed polysaccharidecontaining eye drop in dry eye syndrome: Results of an interventional, comparative, clinical study

Medical Hypothesis, Discovery & Innovation in Optometry ◽

10.51329/mehdioptometry128 ◽

2021 ◽

Vol 2 (2) ◽

pp. 71-76

Author(s):

Naser Nozari ◽

Shahrokh Ramin

Keyword(s):

Dry Eye ◽

Ocular Surface ◽

Dry Eye Disease ◽

Ocular Surface Disease ◽

Eye Disease ◽

Eye Drops ◽

Artificial Tears ◽

Mean Values ◽

The Mean ◽

Contralateral Eye

Background: The mainstay of dry eye treatment is artificial tear solutions. Contralateral eye comparison of 2 types of artificial tears (Xiloial versus Tearlose) in managing dry eye disease was sought in this study. Methods: This study was a prospective, interventional, contralateral eye comparison of 2 types of artificial tears used for managing dry eye disease. The study participants were categorized into mild (13–22 points), moderate (23–32 points), or severe (33–100 points) ocular surface disease according to the baseline ocular surface disease index (OSDI) questionnaire score. Schirmer I and tear film break-up time (TBUT) tests, as well as detailed slit-lamp examinations, were performed at baseline and at the end of the study. All participants received Xiloial monodose eye drops for the right eye and Tearlose eye drops for the left eye, administered as a single drop 4 times per day. Furthermore, they were instructed to perform lid hygiene every 12 hours per day for both eyes. Results: Thirty-five patients (70 eyes) with a mean ± standard (SD) age of 50.2 ± 13.4 years were included, and 14 (40%) were men. The mean ± SD of the OSDI score was 44.24 ± 22.59 at baseline. Of the 35 patients, 10 (28.6%), 5 (14.3%), and 20 (57.1%) had mild, moderate, and severe ocular surface disease, respectively, according to the baseline OSDI score. Compared to baseline, the mean values of both TBUT and Schirmer I tests improved significantly in both groups (both P < 0.001). In comparing the final mean values between the 2 groups, this improvement was comparable for the Schirmer I test (P = 0.179), but TBUT in Tearlose-instilled eyes improved significantly more than in the fellow eyes (P < 0.001). Conclusions: Both Xiloial and Tearlose eye drops improved tear stability and tear production after a 2 week treatment period in eyes with dry eye disease. This improvement was comparable for tear production, but Tearlose-instilled eyes showed significantly greater improvement in tear stability. Further studies with longer follow-up and larger sample sizes could provide more reliable results as a basis for the clinical use of this TSP-containing lubricant eye drop solution in dry eye disease.

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Prospective study comparing Xalatan® eye drops and two similar generics as to the efficacy and safety profile

European Journal of Ophthalmology ◽

10.1177/1120672117747030 ◽

2018 ◽

Vol 28 (4) ◽

pp. 378-384 ◽

Cited By ~ 2

Author(s):

Andreas Diagourtas ◽

Kostantinos Kagelaris ◽

Kostantinos Oikonomakis ◽

Andreas Droulias ◽

Nikolaos Kokolakis ◽

...

Keyword(s):

Intraocular Pressure ◽

Safety Profile ◽

Ocular Surface ◽

Disease Index ◽

Ocular Surface Disease ◽

Eye Drops ◽

Efficacy And Safety ◽

Ocular Surface Disease Index ◽

Significant Difference ◽

The Mean

Purpose: To evaluate the efficacy and safety between two generic prostaglandins Lataz–Xalaprost (Greece) and the corresponding original drops (Xalatan®). Material and methods: In this prospective randomized study, 60 patients diagnosed with open-angle glaucoma or ocular hypertension were enrolled, who had never received antiglaucoma treatment. Subjects were divided randomly into three groups (Xalatan, Lataz, and Xalaprost groups) and they were studied over 16 weeks. At each visit, the mean applanation tonometry values and tear break-up time were measured. The Ocular Surface Disease Index questionnaire was used to evaluate patient’s symptoms. Results: There was a statistically significant difference (p < 0.001) in the mean values of the intraocular pressure between the baseline and the last visit (Xalatan group: from 23.11 ± 1.61 mmHg to 15.81 ± 1.22 mmHg, Lataz group: from 23.26 ± 1.33 mmHg to 15.80 ± 1.47 mmHg, and Xalaprost group: from 23.08 ± 1.45 mmHg to 16.08 ± 1.38 mmHg). Both generic eye drops showed mean percentage intraocular pressure reduction comparable to the standards of prostaglandin analogues (Xalatan: 31.57%, Lataz: 32.06%, and Xalaprost: 30.34%). Xalatan reduced the tear break-up time less, followed by Lataz and then by Xalaprost (Xalatan: from 8.5 to 8 s, Lataz: from 8.2 to 7.4 s, and Xalaprost: from 8.7 to 7.7 s). Xalatan presented the best safety profile, followed by Lataz and least was Xalaprost, according to Ocular Surface Disease Index questionnaire’s results. Conclusion: No significant difference was recorded in the effectiveness of each generic prostaglandin compared to the original. Furthermore, no patient had to change medication. The differences that arose in the safety profile of the three eye drops suggest a prompt closer initial monitoring of patients who are administered generic eye drops.

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Effect of a formulated eye drop with Leptospermum spp honey on tear film properties

British Journal of Ophthalmology ◽

10.1136/bjophthalmol-2019-315160 ◽

2020 ◽

Vol 104 (10) ◽

pp. 1373-1377

Author(s):

Jacqueline Tan ◽

Tianni Jia ◽

Roslyn Liao ◽

Fiona Stapleton

Keyword(s):

Dry Eye ◽

Evaporation Rate ◽

Tear Film ◽

Eye Drops ◽

Ocular Surface Disease Index ◽

Film Properties ◽

Film Evaporation ◽

Before And After ◽

Registration Number ◽

Corneal Staining

AimTo evaluate the effects of a proprietary formulated eye drop with Leptospermum spp honey versus a conventional lubricant eye drop on tear film properties in subjects with symptoms related to dry eye disease after 28 days of treatment.MethodsForty-six subjects with symptoms related to dry eye (Ocular Surface Disease Index (OSDI) score >12) were enrolled and randomly assigned to receive either the test formulated eye drop (Optimel by Melcare Biomedical Pty Ltd) or control eye drops (Alcon, USA) in this double-masked study. Inferior lipid layer thickness (LLT), tear film evaporation rate (TER), fluorescein tear film break-up time (TBUT), corneal staining and subjective symptoms (OSDI and visual analogue scales (VAS)) were measured before and after 28 days of instilling the eye drops.ResultsForty-two subjects completed the study (21 subjects in each group). After 28 days of treatment, TER showed a significantly greater reduction with the formulated eye drop compared with the control (p=0.01). TBUT showed a slight but not statistically significant increase with the formulated eye drop compared with the control (p=0.06), and a significantly greater reduction (improvement) in OSDI scores was observed with the formulated eye drop compared with the control (p=0.01). No significant differences were found between the two groups for inferior LLT, corneal staining and any of the VAS scores.ConclusionsThe formulated eye drops were effective in reducing tear film evaporation rate and were more effective for improving symptoms of dry eye compared with the control eye drops after 28 days of treatment.Trial registration numberNCT03622619.

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A Comparison of Symptoms and Signs in Patients with Inflammatory Dry Eye Disease using two Commercially Available Treatment Formulations of Cyclosporine A

10.21203/rs.3.rs-716429/v1 ◽

2021 ◽

Author(s):

Jonatan Olafsson ◽

Snorri Olafsson ◽

Hugo Lewi Hammer ◽

Behzod Tashbayev ◽

Øygunn A. Utheim ◽

...

Keyword(s):

Dry Eye ◽

Cyclosporine A ◽

Ocular Surface ◽

Ocular Surface Disease Index ◽

Treatment Groups ◽

Surface Staining ◽

Work Up ◽

Symptoms And Signs ◽

Significant Superiority ◽

Ocular Surface Inflammation

Abstract Purpose: Dry eye (DED) is a multifactorial disease of the ocular surface in which ocular surface inflammation and damage play etiological roles. In the present study, we compared symptoms and signs in patients with DED treated with 0.1% Cyclosporine A (CsA) cationic emulsion (Ikervis, Santen) and 0.05% CsA anionic emulsion (Restasis, Allergan).Methods: Single-center, retrospective, 202 consecutive DED patients were treated with 0.1% CsA cationic emulsion (Ikervis, n=101) or 0.05% CsA anionic emulsion (Restasis, n=101) over six months. Ophthalmological work-up included Ocular Surface Disease Index (OSDI) questionnaire, fluorescein break-up time (FBUT), fluorescein ocular surface staining (OSS), Schirmer’s test, meibum expressibility (ME), and meibum quality (MQ). Results: In both treatment groups, subgroup analysis revealed a significant improvement of OSDI only in patients with severe symptoms at baseline (OSDI 33-100). Ikervis-treated patients with OSDI <23 at baseline had a significant increase in symptoms. OSS and FBUT improved significantly in most subgroups irrespective of Ikervis or Restasis being used. Regression analysis revealed a significant superiority to Restasis with regard to FBUT improvement and superiority to Ikervis in regards ME improvement. Conclusions: We conclude that there is seemingly no substantial difference in efficacy between the two drugs. The strength of Restasis is increased efficacy at improving FBUT and of Ikervis improving ME.

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Rear 4-minute Schirmer Test, A Modified Indicator of Schirmer Test in Diagnosing Dry Eye

10.21203/rs.3.rs-744613/v1 ◽

2021 ◽

Author(s):

Xin Wang ◽

Xiaojing Fan ◽

Yaying Wu ◽

Yujie Mou ◽

Jinjin Min ◽

...

Keyword(s):

Dry Eye ◽

Tear Film ◽

Meibomian Gland ◽

Patient Evaluation ◽

Schirmer Test ◽

Ocular Surface Disease Index ◽

Tear Secretion ◽

Standard Patient ◽

The Mean ◽

Breakup Time

Abstract This study was desgined to find a reliable and convenient indicator (a modified Schirmer test) to improve the accuracy of assessing tear secretion and diagnosing dry eye. This is a prospective continuous study on 180 volunteers. Schirmer test I without anesthesia was performed once on both eyes to determine the value of normal Schirmer test. The values of tear secretion were recorded in each minute. Examined individuals also underwent other examinations: the standard patient evaluation of eye dryness (SPEED), the Ocular Surface Disease Index (OSDI), fluorescein stain, tear film breakup time (BUT), and Meibomian gland (MG)grading. The participants were divided into two groups: dry eye (DE) groupand non-dry eye (ND) group. The mean age was 39.41±14.05 years in DE group and 37.62±13.17 in ND group. The value of 2-minute Schirmer test, rear 3-minute Schirmer test, rear 4-minute Schirmer test and 5-minute Schirmer test was 5.36±4.63, 5.57±2.11, 7.21±4.13 and 10.93±6.30 respectively in DE group. And these indicators was 8.25±6.80, 2.73±2.31, 7.36±3.42, 11.84±6.16 in ND group. The rear 4-minute ST has significant correlation with OSDI and SPEED in DE group (r =-0.242/-0.183) and in ND gruop(r =-0.316 /-0.373). Meanwhile, rear 4-minute ST had stronger connection with fBUT(r =0.159) and MG (r =-0.162) in DE gruop. And rear 4-minute ST also had higher accuracy in diagnosing severe dry eye and borderline dry eye.The rear 4-minute Schirmer test may be a supplement indicator in assessing tear secretion and diagnosing dry eye.

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