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

2018 ◽  
Vol 28 (4) ◽  
pp. 378-384 ◽  
Author(s):  
Andreas Diagourtas ◽  
Kostantinos Kagelaris ◽  
Kostantinos Oikonomakis ◽  
Andreas Droulias ◽  
Nikolaos Kokolakis ◽  
...  

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.

2018 ◽  
Vol 10 ◽  
pp. 251584141879488 ◽  
Author(s):  
Ali A. Abusharha ◽  
Tariq M. AlShehri ◽  
Abdullah Y. Hakami ◽  
Ali M. Alsaqr ◽  
Raied A. Fagehi ◽  
...  

Purpose: The aim of this study is to evaluate the difference between reflex and basal tear osmolarity among healthy normal subjects. Method: The right eyes of 20 healthy normal male subjects aged 20 to 40 years were recruited for this study. The inclusion criteria for the subjects were the Ocular Surface Disease Index questionnaire score of less than 12 and wetting length of the phenol red thread of more than 10 mm. Tear film osmolarity was assessed using TearLab osmometer. Basic tear osmolarity was measured normally without inducing any irritation to the eye. In order to stimulate reflex tear, subjects were asked to open their eye as long as they can till they feel ocular surface irritation (minimum 20 s). Results: The mean score on the Ocular Surface Disease Index questionnaire was 5.5 ± 3. The mean value obtained from the phenol red thread was 21 ± 4.5 mm. There were no statistically significant differences between the osmolarity readings of basal and reflex tear osmolarity ( p > 0.05). The mean value was 308 ± 12 and 306 ± 9 mOsm/l for basic and reflex tear osmolarity, respectively. Conclusion: This study found that the osmolarity of the basal and reflex tears fell within the same range. The values found in this study are in agreement with published results for normal subjects.


2019 ◽  
Vol 30 (3) ◽  
pp. 439-445
Author(s):  
Elisa Imelde Postorino ◽  
Pasquale Aragona ◽  
Laura Rania ◽  
Rosaria Spinella ◽  
Domenico Puzzolo ◽  
...  

Purpose: To study the effects of xanthan gum eye drops on the ocular surface and conjunctival cytology of patients with mild-moderate dry eye. Methods: This prospective, double-masked, controlled trial included 30 patients (age > 60 and Ocular Surface Disease Index score >12 and <33), divided into two groups of 15 subjects and treated with 0.2% xanthan gum eye drops (group 1) or 0.5% carboxymethylcellulose (group 2) qid. After a run-in period with saline qid, patients were evaluated by Ocular Surface Disease Index questionnaire, clinical assessment, and impression cytology at baseline (T0) and after 1 month (T1). For impression cytology, cellularity, cell-to-cell contacts, nucleus/cytoplasm ratio, chromatin aspect, goblet cells distribution, keratinization, and the presence of inflammatory cells were considered. Parameters were scored from 0 (no alterations) to 3 (evident alterations). For statistical analysis, Student’s t-test, Wilcoxon rank-sum test, and Mann–Whitney U-test were used. Results: Clinically, after 1 month of treatment, group 1 showed an improvement of corneal stain (T0 = 1.1 ± 1.4; T1 = 0.5 ± 0.7; p = 0.03) and a reduction of Schirmer I test (T0 = 9.8 ± 6.1; T1 = 5.9 ± 4.1; p = 0.001). In group 2, no differences were found between T0 and T1 for all the clinical tests. For impression cytology, in group 1 cellularity (T0 = 0.6 ± 0.5; T1 = 0.3 ± 0.5; p = 0.05), chromatin aspect (T0 = 1.2 ± 0.4; T1 = 0.8 ± 0.5; p = 0.01), keratinization (T0 = 1 ± 0.7; T1 = 0.5 ± 0.5; p = 0.03), and total score (T0 = 5.8 ± 1.3; T1 = 3.6 ± 1.7; p = 0.003) were significantly ameliorated, while in group 2 only total score improved significantly (T0 = 5 ± 1.4; T1 = 4.3 ± 1.5; p = 0.01). The comparison between groups showed significant amelioration for keratinization in group 1 at T1 (p = 0.02). Conclusion: The treatment with xanthan gum, a molecule with anti-oxidant and mucoadhesive properties, ameliorated conjunctival epithelium of mild-moderate dry eye patients better than carboxymethylcellulose.


2019 ◽  
Vol 17 (1) ◽  
pp. 11-18
Author(s):  
Pedro Navarro Luna ◽  
Alicia Vázquez Mendoza ◽  
Javier Alonso Trujillo ◽  
Álvaro Édgar González Aragón Pineda ◽  
Óscar Antonio Ramos Montes

Objetive: To report the prevalence of dry eye and to determine the differences between young and adult patients attending the Optometry Clinic of the Iztacala School of Higher Education at Universidad Nacional Autónoma de México (UNAM). Material and methods: In 1957, patients between the ages of 15 and 65 assessed at the “Centro de Diagnóstico de Alteraciones deSuperficie Ocular” of the Iztacala School of Higher Education of UNAM between August 2016and August 2017. The patients answered the digital version of the Ocular Surface Disease Index(OSDI) diagnostic questionnaire and the mucin arborization pattern was evaluated using the TearFerning Test (TFT). Results: The mean prevalence of the diagnosis with a significant differenceof positive P 0.05 for Ferning (59.1%) and OSDI (63.8%). Using the Ferning technique in youngpatients (15 to 29 years), it was possible to assess a prevalence of dry eye of 51.9%; whereas inadults (30 to 65 years) it was 66.9%. Using the OSDI questionnaire, the prevalence was 60.1% inyoung people and 67.8% in adults; in addition, for each year of increase in age, the probabilityof having a dry eye increased by 1% with OSDI and 2% with Ferning. Conclusions: With thisstudy, it was established, for the first time, that the young people who go to the optometry clinicof FES-Iztacala, a sector that had not been previously considered, also suffer from this disease.


Author(s):  
Suwarna Suman ◽  
Prachi Goyal

Aims:  To evaluate and compare the diagnostic values and clinical utility of the Ocular Surface Disease Index (OSDI) questionnaire, the tear film break-up time test (TBUT), and the Schirmer’s test in diagnosing dry eye disease in patients presenting with dry eye symptoms. Study Design: A prospective observational study. Place and Duration of Study: Department of Ophthalmology, AIIMS Jodhpur, Rajasthan, India. Two-month period between July 2016 and September 2016. Methodology: We have included 100 patients aged >20 years having foreign body sensations, burning sensations, pain, dryness, blurred vision, photophobia, redness in the study. Routine ophthalmological examination was performed after OSDI questionnaire, followed by TBUT and Schirmer’s test and outcomes were evaluated. Results: The mean age of 100 participants was 43 ± 15.97years (range 20–78 years). The mean OSDI, TBUT, and Schirmer’s test scores were 58.67± 12.12 (range 30.0–88.9), 5.77 ± 3.49 seconds (range 0–17 seconds), and 09.78 ± 7.93 mm (range 0–32.5 mm), respectively. There was a statistically highly significant inverse correlation between the OSDI and TBUT (r = −0.597, P = <0.0001), statistically significant correlation between TBUT and Schirmer test (r= -0.227, p= 0.023), whereas no significant correlation noted between the OSDI and Schirmer’s test (r= -0.142, p= 0.158).  Conclusion: The prevalence of dry eye disease (DED) is increasing these days. For early recognition and treatment, we need rapid, reliable and less invasive diagnostic test in daily practice. The OSDI together with the TBUT is less time consuming, easy to perform and can be useful in diagnosis of DED.


2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Orsolya Németh ◽  
Achim Langenbucher ◽  
Timo Eppig ◽  
Sabine Lepper ◽  
Georgia Milioti ◽  
...  

Purpose. Keratoconus (KC) has been defined as a “noninflammatory” corneal disease, but recent studies have noted a potential inflammatory origin. We analysed the Ocular Surface Disease Index (OSDI) and ocular surface temperature (OST) in KC patients compared to controls. Patients and Methods. A total of 179 eyes in 90 patients with KC (topographic keratoconus classification 0-1 to 4, age 36.1 ± 12.5 years, 65.9% males) and 82 eyes in 41 controls (age 36.4 ± 12.8 years, 47.6% males) were examined. The participants completed the OSDI questionnaire and underwent corneal topography, tomography, and thermography. Additional outcome measures were vision- and discomfort-related OSDI subscores and mean OST  at the corneal centre during 10 seconds of sustained eye opening after blinking. Results. The OSDI score (31.4 ± 22.4 vs. 17.5 ± 17.9) and vision- (17.7 ± 14.6 vs. 10.5 ± 13.2) and discomfort-related (14.3 ± 10.7 vs. 9.4 ± 10.5) OSDI subscores were significantly higher in KC patients than in controls (p<0.001). We found no significant difference in the central corneal OST (34.2 ± 0.6°C vs. 34.2 ± 0.7°C; p=0.41) between the two groups (p≥0.22). The OSDI score and subscores poorly to fairly correlated with the surface asymmetry index (SAI) and surface regularity index (SRI; r > 0.174, p<0.005), but did not correlate with the central corneal OST (r < 0.001). OST  also did not correlate with the SAI, SRI, and central corneal thickness (r ≥ −0.086). Conclusion. KC patients had increased OSDI scores and vision- and discomfort-related OSDI subscores without an increase in the OST compared to a normal population. OSDI score/subscores weakly correlate with SAI and SRI but do not correlate with OST in KC patients or controls. Vision- and discomfort-related symptoms of KC have to be managed in parallel in ophthalmological practice, but the necessity of anti-inflammatory treatment cannot be verified through ocular thermography.


Vision ◽  
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 ◽  
...  

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.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Dai Woo Kim ◽  
Jonghoon Shin ◽  
Chang Kyu Lee ◽  
Myungjin Kim ◽  
Sohyeon Lee ◽  
...  

AbstractGiven that nonadherence is related to subject characteristics and drug tolerance and preserved eye drops tend to be more intolerable than preservative-free ones, we conducted a phase 4, parallel-grouped, investigator-blind, active-control, randomized, multicenter study. A total of 51 patients with intraocular pressure (IOP) ≥ 15 mmHg diagnosed with open-angle glaucoma or ocular hypertension were randomly assigned to the preserved latanoprost group (n = 26) and the preservative-free latanoprost group (n = 25). The efficacy variables were corneal/conjunctival staining grade, Ocular Surface Disease Index (OSDI), adherence at 12 weeks after the first administration; corneal/conjunctival staining grade at 4 weeks; and IOP, tear break-up time (TBUT), and hyperemia score at 4 and 12 weeks. The safety variables included visual acuity and drug tolerance questionnaire results. There was no statistically significant difference in corneal/conjunctival staining grade, OSDI, or TBUT between the groups at 4 and 12 weeks. However, the adherence rate was higher and the hyperemia score was lower in the preservative-free group than in the preserved group. The severity and duration of stinging/burning sensation were lower in the preservative-free group than in the preserved group. Overall, preservative-free latanoprost showed better ocular tolerance assessed by hyperemia scores and stinging/burning symptoms following higher adherence than preserved latanoprost.


2021 ◽  
Vol 11 (04) ◽  
pp. 253-265
Author(s):  
Nawreen Binte Anwar ◽  
Basil Anwar ◽  
Arup Krishna Choudhury ◽  
Mahfuza Rahman Khan ◽  
Md. Anisur Rahman

2021 ◽  
Vol 14 (10) ◽  
pp. 1595-1601
Author(s):  
May M. Bakkar ◽  
◽  
Mohammad Al Qadire ◽  

AIM: To develop an Arabic version of the ocular surface disease index (OSDI) and to assess its reliability and validity. METHODS: A cross sectional study was carried out to validate the Arabic version of the OSDI questionnaire. Initially, forward-backward translation was used to translate the English version of OSDI into Arabic. The translated questionnaire was tested for equivalence and cultural adaptability. Totally 200 subjects were then recruited from a non-clinical population and asked to complete the Arabic version of the OSDI (ARB-OSDI). The reliability of the questionnaire was assessed using Cronbach’s-α. A subgroup of 30 participants was asked to complete the questionnaire on two occasions to test the test-retest reliability. RESULTS: A total of 200 participants were enrolled in the study. The average age of the study participants was 31.21±13.2y and 57% were male. An acceptable internal consistency level for the ARB-OSDI questionnaire measured by Cronbach’s-α was revealed. All questions showed good internal consistency. Test-retest reliability analysis revealed good stability (interclass correlation coefficient, r=0.832, P<0.001). The construct validity for the questionnaire was also high. CONCLUSION: The ARB-OSDI questionnaire shows very good psychometric properties (acceptable internal consistency and test-retest reliability). That makes the questionnaire a valid potential tool to use in Arabic-speaking countries to monitor symptoms of dry eye disease in a larger population.


2018 ◽  
Vol 34 (3) ◽  
pp. 256-259 ◽  
Author(s):  
Alper Yazıcı ◽  
Esin Sarı ◽  
Erkan Ayhan ◽  
Gözde Şahin ◽  
Nesime Setge Tıskaoğlu ◽  
...  

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