Health Condition 1: null- For the treatment of Dry Eye signs and symptoms. Health Condition 2: H041- Other disorders of lacrimal gland
Conditions
Interventions
Intervention1: 2% Rebamipide ophthalmic suspension: 1 drop in affected eye(s) Four times daily for 24 weeks
Control Intervention1: 0.1 % Sodium Hyaluronate: 1 drop in affected eye(s) Four times daily
Sponsors
Ajanta Pharma Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.A clinical diagnosis Dry Eye at least since from 20 months. 2.Anesthetized Schirmer test score of 0 to 9 mm per 5minutes or less or tear breakup time is 5 seconds or less. 3.Best corrected visual acuity of 0.2 or better in both eyes. 4.Voluntary willingness to give written informed consent prior to participation in trial. 5.Wash out period for subjects who are on medications for same condition will be 3 days.
Exclusion criteria
Exclusion criteria: 1.Any active inflammation of eyes. 2.Any long lasting inflammation of eyes. 3.Subject with block nasal duct. 4.Subjects with history of recurrent corneal erosions diagnosed by slit lamp examination. 5.Subjects with history of epithelial basement membrane dystrophy. 6.Subjects with history of floppy eyelid syndrome diagnosed by Slit lamp examination 7.Subjects with history of Conjunctivochalasis diagnosed by slit lamp examination 8.Anterior segment disease like Glaucoma or Ocular Hypertension. 9.Using Cyclosporine since long time 10.Use of contact lenses 11.Use of topically instilled Ocular medication during study. 12.History of Ocular surgery within 12 months. 13.Females who are pregnant, lactating, or child bearing potential. 14.Females who are not willing to remain abstinent or use contraception. 15.Subjects who are on systemic Hormonal or corticosteroid therapy. 16.Subjects with history of Diabetes Mellitus. 17.Presence of Stevens Johnson Syndrome. 18.Ocular surgery due to Dry eye Syndrome. 19.Use of topical &/or systemic treatment potentially interfering with tear production. 20.Concurrent involvement in another study or previous receipt of same drug. 21.Any ocular condition that, in the opinion of the investigator, could affect the subjectâ??s safety or trial parameters. 22.Known contraindications or sensitivities to the study medication or its components. 23.Other patients who are in the opinion of the investigator/sub investigator were inappropriate for the study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine Efficacy of 2% Rebamipide Ophthalmic Suspension compared to 0.1% Sodium Hyaluronate for the treatment of patients with Dry eye.Timepoint: Day1, 4th week, 8th week, 12thweek, 16th week, 20thweek, 24thweek | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢To determine Safety and Tolerability of 2% Rebamipide Ophthalmic Suspension Compared to 0.1% Sodium Hyaluronate in patients with Dry eye â?¢Global assessment of study medication by Investigators and Patients Timepoint: Day1, 4th week, 8th week, 12thweek, 16th week, 20thweek, 24thweek | — |
Countries
India
Contacts
Public ContactDr Shailesh Singh
Ajanta Pharma Ltd
Outcome results
None listed