Effect of a Novel Multi-Ingredient Formulation on Management of Dry Eye Discomfort in a Randomized, Double-Blind, Placebo-Controlled Human Clinical Study

Abstract Objectives Dry eye is a chronic condition associated with insufficient tear production and faster tear evaporation and commonly accompanied by inflammation that may lead to ocular surface damage. We have developed a multi-ingredient formulation containing lutein, zeaxanthin, curcumin, and vitamin D3 to address conditions associated with dry eye. The objective of this study was to evaluate the efficacy and safety of our formulation in subjects with mild to moderate dry eye symptoms. Methods This was a randomized, double-blind, parallel, placebo-controlled study. Sixty subjects with mild to moderate DES were randomly assigned in a 1 : 1 ratio to the test or placebo groups. Subjects consumed one capsule of the test or placebo product every morning through the study duration of 56 days. The test product comprised 20 mg lutein, 4 mg zeaxanthin, 200 mg curcuminoids, and 600 IU vitamin D3 in form of a capsule. The placebo product contained soybean oil. Changes in tear volume by Schirmer's test and severity of dry eye discomfort measured by Ocular Surface Disease Index (OSDI) score, changes in Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire, tear film break up time (TBUT), corneal & conjunctival staining, tear osmolarity, Matrix Metalloproteinases (MMP)-9 levels in tear fluid, and artificial tear usage were evaluated. Results Thirty subjects in Test and 29 in Placebo group completed study. We observed statistically significant (P < 0.05) improvements in tear volume, TBUT, and a reduction in dry eye discomfort as measured by OSDI and SPEED scores from baseline to day 56 in the Test group. Mean corneal & conjunctival staining scores, tear osmolarity and tear MMP-9 levels also showed significant improvements (P < 0.05) when compared to Placebo on day 56. Artificial tear usage & frequency of usage were significantly reduced (P < 0.05) in test group as compared to Placebo. Products were well tolerated without any adverse events. Conclusions Our multi-ingredient formulation demonstrated significant improvement in dry eye conditions including eye hydration and moisture, tear stability and quality, and overall improvements in eye comfort. Funding Sources OmniActive Health Technologies

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A Randomized Study of the Efficacy and Safety of 0.1% Cyclosporine a Cationic Emulsion in Treatment of Moderate to Severe Dry Eye

European Journal of Ophthalmology ◽

10.5301/ejo.5000952 ◽

2017 ◽

Vol 27 (5) ◽

pp. 520-530 ◽

Cited By ~ 25

Author(s):

Christophe Baudouin ◽

Francisco C. Figueiredo ◽

Elisabeth M. Messmer ◽

Dahlia Ismail ◽

Mourad Amrane ◽

...

Keyword(s):

Dry Eye ◽

Cyclosporine A ◽

Ocular Surface ◽

Severe Disease ◽

Randomized Study ◽

Treatment Compliance ◽

Controlled Study ◽

Efficacy And Safety ◽

Ocular Surface Disease Index ◽

Ocular Discomfort

Purpose The SICCANOVE study aimed to compare the efficacy and safety of 0.1% cyclosporine A cationic emulsion (CsA CE) versus vehicle in patients with moderate to severe dry eye disease (DED). Methods In this multicenter, double-masked, parallel-group, controlled study, patients were randomized (1:1) to receive CsA CE (Ikervis®) or vehicle for 6 months. The co-primary efficacy endpoints at month 6 were mean change from baseline in corneal fluorescein staining (CFS; modified Oxford scale) and in global ocular discomfort (visual analogue scale [VAS]). Results The mean change in CFS from baseline to month 6 (CsA CE: n = 241; vehicle: n = 248) was significantly greater with CsA CE than with vehicle (-1.05 ± 0.98 and -0.82 ± 0.94, respectively; p = 0.009). Ocular discomfort improved similarly in both groups; however, the percentage of patients with ≥25% improvement in VAS was significantly higher with CsA CE (50.2%) than with vehicle (41.9%; p = 0.048). In a post hoc analysis of patients with severe ocular surface damage (CFS score 4) at baseline (CsA CE: n = 43; vehicle: n = 42), the percentage of patients with improvements of ≥2 grades in CFS score and ≥30% in Ocular Surface Disease Index score was significantly greater with CsA CE (p = 0.003). Treatment compliance and ocular tolerability were satisfactory and as expected for CsA use. Conclusion Cyclosporine A CE was well-tolerated and effectively improved signs and symptoms in patients with moderate to severe DED over 6 months, especially in patients with severe disease, who are at risk of irreversible corneal damage.

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Dry eye and Meibomian gland dysfunction evaluation in sarcoidosis patients

European Journal of Ophthalmology ◽

10.1177/11206721211006579 ◽

2021 ◽

pp. 112067212110065

Author(s):

Pelin Kiyat ◽

Melis Palamar ◽

Bengu Gerceker Turk

Keyword(s):

Dry Eye ◽

Ocular Surface ◽

Tear Film ◽

Surface Damage ◽

Meibomian Gland ◽

Drop Out ◽

Meibomian Gland Dysfunction ◽

Ocular Surface Disease Index ◽

Group 2 ◽

Group 1

Purpose: To analyze the relation between Meibomian gland dysfunction, dry eye, and sarcoidosis. Materials and Methods: Twenty eyes of 10 sarcoidosis patients (Group 1) and 20 left eyes of 20 age-sex matched healthy volunteers (Group 2) were included. Presence of dry eye was evaluated with Schirmer 1 test, tear film break-up time (T-BUT), Oxford scale scoring, Ocular Surface Disease Index (OSDI) score assessments. A slit-lamp biomicroscope infrared filter (Topcon, SL-D701, IJssel, The Netherlands) was used to evaluate Meibomian glands. The drop-out ratio according to meibography was scored for each eyelid from grade 0 (no loss) through grade 3 (lost area >2/3 of the total Meibomian gland area). Results: Among dry eye tests mean Schirmer 1 and T-BUT values were lower and OSDI score was higher in Group 1 compared to Group 2 and the differences were statistically significant ( p = 0.017, p = 0.039, p = 0.003, respectively). In addition, the upper, lower and total meiboscores were statistically significantly higher in Group 1 ( p = 0.047, p = 0.003, p = 0.005, respectively). Conclusion: A significantly higher presence of dry eye and Meibomian gland drop out ratios was detected in sarcoidosis patients. It is important to monitor sarcoidosis patients for dry eye and Meibomian gland dysfunction and when detected, to treat adequately to prevent ocular surface damage.

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The Effects of 6-Month Vitamin D Supplementation during the Non-Surgical Treatment of Periodontitis in Vitamin-D-Deficient Patients: A Randomized Double-Blind Placebo-Controlled Study

Nutrients ◽

10.3390/nu12102940 ◽

2020 ◽

Vol 12 (10) ◽

pp. 2940

Author(s):

Marina Perić ◽

Dominique Maiter ◽

Etienne Cavalier ◽

Jérôme F. Lasserre ◽

Selena Toma

Keyword(s):

Vitamin D ◽

Vitamin D3 ◽

Test Group ◽

Controlled Study ◽

Control Group ◽

Controlled Clinical Trial ◽

Pocket Depth ◽

Double Blind ◽

Double Blind Placebo ◽

Significant Difference

Background: This study assessed the effects of weekly vitamin D (VD) supplementation on clinical and biological parameters after scaling and root planning (SRP) in the treatment of periodontitis and served to validate the VD dosage regimen. Methods: It was a monocentric, randomized, double-blind, placebo-controlled clinical trial with 6 months follow-up. Healthy Caucasian periodontitis patients presenting serum 25(OH) vitamin D3 below 30 ng/mL were randomly allocated to test group (SRP + VD 25,000 international units (IU)/week) or the control group (SRP + placebo). Results: A total of 59 patients were screened, 27 were included and 26 completed 3 months (M) and 21 completed 6M control. Test (n = 13) and control groups (n = 14) had similar 25(OH) vitamin D3 levels at baseline (17.6 ± 7.4 vs. 14.4 ± 5.2, respectively). After one month, there was a significant difference between groups (32.9 ± 5.2 vs. 16.1 ± 4.7), also seen at M3 and M6 (t-test, p < 0.001). Periodontal treatment was successful in both groups, since it resulted in a reduction of all measured clinical parameters at M3 and M6 (probing pocket depth (PPD), full mouth bleeding and plaque). However, the reduction in PPD was greater in the test group. Conclusions: In this short-term pilot study, no significant differences were observed between two groups. However, supplementation with VD tended to improve the treatment of periodontitis in patients with initial 25(OH) vitamin D3 < 30 ng/mL and proved safe and efficacious. NCT03162406.

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Beneficial effects of black bean (Rhynchosia volubilis) on ocular surface damage induced by benzalkonium chloride in mouse model of dry eye

10.1055/s-0037-1608307 ◽

2017 ◽

Author(s):

A Kim Kyung ◽

W Kang Suk ◽

H Lee Chung ◽

J Yang Sung ◽

K Kang Tae ◽

...

Keyword(s):

Mouse Model ◽

Dry Eye ◽

Ocular Surface ◽

Benzalkonium Chloride ◽

Surface Damage ◽

Black Bean ◽

Beneficial Effects

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Evaluation of Dry Eye after Implantable Collamer Lens Surgery

Ophthalmic Research ◽

10.1159/000511197 ◽

2020 ◽

Author(s):

Haiting Chen ◽

Xueyan Feng ◽

Guangzeng Niu ◽

Yuxiang Fan

Keyword(s):

Dry Eye ◽

Ocular Surface ◽

Case Series ◽

Meibomian Gland ◽

Quality Score ◽

Control Group ◽

Ocular Surface Disease Index ◽

Implantable Collamer Lens ◽

Lens Surgery ◽

Breakup Time

Objectives: To evaluate dry eye (DE) and associated meibomian gland dysfunction parameters after Implantable Collamer Lens (ICL) surgery. Methods: This is a prospective observational case series. Patients who underwent ICL implantation without previous ocular diseases or ophthalmic treatments were enrolled. Their Ocular Surface Disease Index (OSDI), noninvasive breakup time (NIBUT), meibography, slit-lamp examination of the lid margin, corneal fluorescein staining (CFS), and Schirmer test I were examined preoperatively and at 1 and 3 months postoperatively. Results: A total of 117 eyes of 60 patients were enrolled, and 107 eyes completed 3-month follow-up period. OSDI, lid marginal abnormality, and meibomian gland (MG) secretion, and meibum quality score were significantly higher at 1 month postoperatively and recovered partially at 3 months after surgeries, while NIBUT was significantly decreased all the time. Patients with previous DE symptoms (OSDI score ≥12) showed not only lower Schirmer and TBUT values but also higher CFS, lid margin score, MG loss, MG secretion, and meibum quality scores compared with those in the control group after operations. Low Schirmer, NIBUT values, and high meibum quality score were determined as risk factors for DE symptoms after ICL surgery. Conclusions: ICL implantation has a bad influence on the ocular surface and MG functions. The influence may be more obvious in patients with existing DE.

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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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Reliability and validity of the Japanese version of the Ocular Surface Disease Index for dry eye disease

BMJ Open ◽

10.1136/bmjopen-2019-033940 ◽

2019 ◽

Vol 9 (11) ◽

pp. e033940 ◽

Cited By ~ 7

Author(s):

Akie Midorikawa-Inomata ◽

Takenori Inomata ◽

Shuko Nojiri ◽

Masahiro Nakamura ◽

Masao Iwagami ◽

...

Keyword(s):

Internal Consistency ◽

Dry Eye ◽

Ocular Surface ◽

Discriminant Validity ◽

Reliability And Validity ◽

Japanese Version ◽

Disease Index ◽

Eye Disease ◽

Ocular Surface Disease Index ◽

Test Retest Reliability

ObjectivesThe Ocular Surface Disease Index (OSDI) questionnaire is widely used to evaluate subjective symptoms of dry eye disease (DED) as a primary diagnostic criterion. This study aimed to develop a Japanese version of the OSDI (J-OSDI) and assess its reliability and validity.Design and settingHospital-based cross-sectional observational study.ParticipantsA total of 209 patients recruited from the Department of Ophthalmology at Juntendo University Hospital.MethodsWe translated and culturally adapted the OSDI into Japanese. The J-OSDI was then assessed for internal consistency, reliability and validity. We also evaluated the optimal cut-off value to suspect DED using an area under the receiver operating characteristic curve (AUC) analysis.Primary outcome measuresInternal consistency, test–retest reliability and discriminant validity of the J-OSDI as well as the optimal cut-off value to suspect DED.ResultsOf the participants, 152 had DED and 57 did not. The J-OSDI total score showed good internal consistency (Cronbach's alpha=0.884), test–retest reliability (interclass correlation coefficient=0.910) and discriminant validity by known-group comparisons (non-DED, 19.4±16.0; DED, 37.7±22.2; p<0.001). Factor validity was used to confirm three subscales within the J-OSDI according to the original version of the questionnaire. Concurrent validity was assessed by Pearson correlation analysis, and the J-OSDI total score showed a strong positive correlation with the Dry Eye-Related Quality-of-Life Score (γ=0.829). The optimal cut-off value of the J-OSDI total score was 36.3 (AUC=0.744).ConclusionsThe J-OSDI was developed and validated in terms of reliability and validity as an effective tool for DED assessment and monitoring in the Japanese population.

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Dry Eye Syndrome-Related Quality of Life in Glaucoma Patients

European Journal of Ophthalmology ◽

10.1177/112067210901900409 ◽

2009 ◽

Vol 19 (4) ◽

pp. 572-579 ◽

Cited By ~ 78

Author(s):

Gemma Caterina Maria Rossi ◽

Carmine Tinelli ◽

Gian Maria Pasinetti ◽

Giovanni Milano ◽

Paolo Emilio Bianchi

Keyword(s):

Quality Of Life ◽

Dry Eye ◽

Ocular Surface ◽

Cross Sectional Study ◽

Dry Eye Syndrome ◽

Control Group ◽

Ocular Surface Disease Index ◽

Symptom Scale ◽

Cross Sectional

Purpose To verify the presence of dry eye syndrome (DES) in treated patients with glaucoma and to analyze DES's impact on the patients' quality of life (QOL) versus the control group. Methods In this observational cross-sectional study, 61 patients were enrolled at a clinical practice. Patients were divided into three groups by number of glaucoma drops instilled per day (G1=1 drop/day, G2=2 drops/day, G3=3 drops/day). A control group of 20 subjects was also selected (G0). All subjects were submitted to a complete ocular examination (including tear function and ocular surface status) and completed the 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ), Glaucoma Symptom Scale (GSS) questionnaire, and Ocular Surface Disease Index (OSDI). DES was defined as presence of punctate keratitis and decreased break-up time. Statistical analysis was performed applying the Kruskal-Wallis analysis of variance and Mann-Whitney U tests (to compare median values between groups) as well as the χ2 and Fisher test (to verify significant differences). Results A total of 40% of G3 and 39% of G2 patients presented DES versus 11% of G1 and 5% of G0 (p=0.01). QOL was significantly influenced and altered (NEI-VFQ 25 total mean and GSS total mean and symptoms average: p=0.0085, p=0.006, and p=0.03, respectively). OSDI pointed out differences by group: 26% of G2 and 15% of G3 presented moderate OSDI and 15% of G3 and 8.7% of G2 severe OSDI (p>0.05). Conclusions Patients with topically treated glaucoma present DES more often than a similar control group (p=0.01). The presence of DES negatively influences the patient's QOL. The patients with glaucoma's ocular surface status should be evaluated regularly to ensure the timely detection and treatment of pathologic signs on the ocular surface.

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