A Clinical study to check the effect and safety of Olopatadine Hydrochloride Ophthalmic Solution 0.7% w/v compared with Olopatadine Hydrochloride Ophthalmic Solution 0.2% w/v in patients suffering with ocular itching associated with allergic conjunctivitis.

Phase 3

Completed

• Conditions: Other conjunctivitis,

• Registration Number: CTRI/2018/05/013693
• Lead Sponsor: Ajanta Pharma Ltd

Brief Summary

This is a “A Phase III, Multicenter, Comparative,Randomized, Double blind, Two arm, Parallel group Clinical Study to evaluateEfficacy and Safety of Olopatadine Hydrochloride Ophthalmic Solution 0.7% w/v as compared withOlopatadine Hydrochloride Ophthalmic Solution 0.2% w/v for the treatment of Ocular Itchingassociated with Allergic Conjunctivitis.â€

Primary objective is to evaluate the efficacy of Olopatadine HydrochlorideOphthalmic Solution 0.7% w/v compared with Olopatadine Hydrochloride OphthalmicSolution 0.2% w/v for the treatment of ocular itching associated with AllergicConjunctivitis.

Secondary objective is to evaluate the safety of Olopatadine HydrochlorideOphthalmic Solution 0.7% w/v compared with Olopatadine Hydrochloride OphthalmicSolution 0.2% w/v for the treatment of ocular itching associated with AllergicConjunctivitis.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-21
• Study Completion: 2018-10-24
• Last Update Posted: 2019-12-02

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• 1.Male or female subjects, aged 10 years to 65 years (both inclusive).
• 2.Treatment naïve subjects with diagnosis of ocular itching associated with allergic conjunctivitis in one or both the eyes.
• 4.Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.

Exclusion Criteria

• 1.Subjects with any contraindications or hypersensitivities to the use of the study medication or their components.
• 2.Subjects who are blind or subjects with single eye will be excluded from the study.
• 3.Subjects with Visual acuity of 20/80 in any eye.
• 4.Subjects with known case of persistent dry eye syndrome or currently on treatment for dry eyes.
• 5.Subjects with Vernal Keratoconjunctivitis (VKC), Atopic Keratoconjunctivitis (AKC) and Giant Papillary Conjunctivitis (GPC) will be excluded from the study.
• 6.Subjects with presence of ocular infection (bacterial, viral or fungal) or history of ocular herpes within 30 days of screening visit.
• 7.Subjects with presence of active blepharitis, active meibomian gland dysfunction, active rosacea affecting the ocular adnexa, follicular conjunctivitis, iritis, preauricular lymphadenopathy, ocular irritation not due to ocular allergy, or any other clinically significant ophthalmic abnormality that may affect the study outcomes.
• 8.Subjects with chronic ocular degenerative condition or active intraocular inflammation that could worsen during the study.
• 9.Subjects with known case of glaucoma will be excluded from the study.
• 10.Subjects with known case of ocular surgery within 6 months or scheduled to undergo ocular surgery during the study period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in ocular itching score on day 1 (Time Frame: 3, 5 and 7 minutes of post first instillation of IMP), day 2 [at 24 hrs (+1 hr) post first instillation of IMP], 7 and 14.	At the end of Day 1, 7 and 14

Secondary Outcome Measures

Name	Time	Method
Change from baseline in conjunctival hyperemia grade on day 1, 7 and 14.	Change from baseline in tearing score at the end of day 2,7 and 14.

Trial Locations

Locations (14)

Ajanta Research Centre; 🇮🇳 Lucknow, UTTAR PRADESH, India

B.J. Medical College; 🇮🇳 Ahmadabad, GUJARAT, India

Christian Medical College and Hospital; 🇮🇳 Ludhiana, PUNJAB, India

Department of Ophthalmology GMERS Medical College & Civil Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Gandhi Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

GCS Medical College; 🇮🇳 Ahmadabad, GUJARAT, India

GSVM Medical College; 🇮🇳 Nagar, UTTAR PRADESH, India

J P M Rotary Club of Cuttack Eye Hospital & Research Institute; 🇮🇳 Cuttack, ORISSA, India

KLES Dr Prabhakar Kore Hospital & Medical Research Centre; 🇮🇳 Belgaum, KARNATAKA, India

Maharaja Agrasen Hospital; 🇮🇳 Delhi, DELHI, India

Scroll for more (4 remaining)

Ajanta Research Centre

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Neeraj Chowdhry

Principal investigator

9839121338

neerajtaurus3@gmail.com