A Clinical study to evaluate Efficacy, Safety and Tolerability of 2% Rebamipide ophthalmic suspension Vs 0.1 % Sodium Hyaluronate Ophthalmic solution for treatment of patients with Dry Eye

Phase 3

Completed

• Conditions: Other disorders of lacrimal gland,

• Registration Number: CTRI/2015/05/005783
• Lead Sponsor: Ajanta Pharma Ltd

Brief Summary

A Multicentric, Double Blind, Randomized, Active Control, Parallel Group Comparative Study to Evaluate the Efficacy, Safety and Tolerability of 2% Rebamipide Ophthalmic Suspension Vs. 0.1 % Sodium Hyaluronate Ophthalmic solution for treatment of patients with Dry Eye.

Dry eye is a condition characterized by a patient’s inability to produce enough tears or the appropriate quality of tears to keep the eye healthy and comfortable. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

The primary end point will be assessed by the change in Fluorescein Corneal Staining (FCS) Score at every visit for 24 weeks of treatment.

The secondary end points are Foreign Body Sensation, Dryness, Photophobia, Eye Pain and blurred vision will be assessed.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-22
• Last Update Posted: 2018-11-24

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

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

• 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.
• 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 subject’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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine Efficacy of 2% Rebamipide Ophthalmic Suspension compared to 0.1% Sodium Hyaluronate for the treatment of patients with Dry eye.	Day1, 4th week, 8th week, 12thweek, 16th week, 20thweek, 24thweek

Secondary Outcome Measures

Name	Time	Method
•To determine Safety and Tolerability of 2% Rebamipide Ophthalmic Suspension Compared to 0.1% Sodium Hyaluronate in patients with Dry eye	•Global assessment of study medication by Investigators and Patients

Trial Locations

Locations (8)

GMERS Medical College & General Hospital; 🇮🇳 Vadodara, GUJARAT, India

Government Regional Eye Hospital; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

Health point Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

King George’s Medical University; 🇮🇳 Lucknow, UTTAR PRADESH, India

Muktai Hospital; 🇮🇳 Nashik, MAHARASHTRA, India

Rajiv Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital; 🇮🇳 Srikakulam, ANDHRA PRADESH, India

Seth G.S. Medical College & K.E.M Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Sir Ganga Ram Hospital; 🇮🇳 West, DELHI, India

GMERS Medical College & General Hospital

🇮🇳Vadodara, GUJARAT, India

Dr Ashwini Sapre

Principal investigator

9825625516

ashwinisapre@yahoo.com