A Clinical Trial to Study the Efficacy, Safety and Tolerability of Bepotastine Besilate Ophthalmic Solution Vs. Olopatadine Hydrochloride Ophthalmic Solution in Subjects Suffering from Allergic Conjunctivitis.

Phase 3

Completed

• Conditions: Other conjunctivitis, Subjects suffering from Allergic Conjunctivitis,

• Registration Number: CTRI/2015/01/005399
• Lead Sponsor: Ajanta Pharma Ltd

Brief Summary

This study is a Comparative, Randomized, Double blind, Parallel group and Non Crossover Multicentric Clinical Study with Bepotastine besilate ophthalmic solution Vs. Olopatadine hydrochloride ophthalmic solution in Subjects Suffering from Allergic Conjunctivitis.

Ocular allergies are very common and range in intensity from mild, self-resolving, acute conditions to serious, chronic disease that can severely affect vision.

 The efficacy parameter is primarilyfocused on ocular itching,conjuctival redness.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-27
• Last Update Posted: 2018-11-24

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• 1.Subject with sign and symptoms of allergic conjunctivitis like ocular itching, eye lid swelling, tearing, photophobia, watery discharge, diagnosis of allergic conjunctivitis will be confirmed by conjunctival smear examination.
• 2.Freshly diagnosed subject or Subjects who are previously diagnosed and on treatment of allergic conjunctivitis will undergo for 3 days wash out period 3.Subject willing to sign informed consent form (ICF) prior to any screening procedure.
• For Minor subject (age below 18yrs) LAR (Legally Acceptable Representative) should be taken with assent.

Exclusion Criteria

• 1.Subjects who took systemic administration of corticosteroids or immunosuppressive agents, or used ophthalmic ointments of corticosteroids within 1 week before instillation of the investigational drugs.
• 2.Use of disallowed medications during the period indicated prior to study enrollment or during the study.
• 3.Subject with dry eyes should be excluded from the trial 4.Subject with Schirmer 10 should be excluded from the study.
• 5.Subject who are blind or subject with single eye.
• 6.Subjects who have planned surgery during trial period.
• 7.Subject with Vernal Keratoconjunctivitis should be excluded from the trial.
• 8.Subjects having corneal epithelial detachment or corneal ulcer in the target eye.
• 9.Subjects who are required to wear contact lens during the study period.
• 10.Subjects who are pregnant or may be pregnant or lactating.
• 11.Subjects who have participated in other clinical studies within 3 months.
• 13.Known contraindications or sensitivities to the study medication or its components.
• 14.Other patients who 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 evaluate the efficacy of Bepotastine besilate ophthalmic solution Vs. Olopatadine hydrochloride ophthalmic solution in Subjects Suffering from Allergic Conjunctivitis.	Day 0,1 week,2 week and 3 week.

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of Bepotastine besilate ophthalmic solution Vs. Olopatadine hydrochloride ophthalmic solution.	Global assessment of study medications by Subjects and Investigators.

Trial Locations

Locations (12)

Apollo Gleneagles Hospitals; 🇮🇳 Kolkata, WEST BENGAL, India

Aster Aadhar Hospital (Prerana Hospital Ltd.); 🇮🇳 Kolhapur, MAHARASHTRA, India

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

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

IPGMER & SSKM Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

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

Lokamanya Tilak Muncipal General Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Post Graduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, CHANDIGARH, India

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

S.P. Medical College and A.G. of Hospital; 🇮🇳 Bikaner, RAJASTHAN, India

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Apollo Gleneagles Hospitals

🇮🇳Kolkata, WEST BENGAL, India

Dr Snehasis Basu

Principal investigator

91-9433361416

Sbasu2003@doctors.net.uk