Safety and Efficacy of Olopatadine Hydrochloride/Ketorolac Tromethamine Ophthalmic Solution Compared With Olopatadine Hydrochloride Ophthalmic Solution in Patients With Seasonal Allergic Conjunctivitis

Phase 3

Completed

• Conditions: Rhinitis, Allergic, Seasonal; Conjunctivitis, Allergic
• Interventions: Drug: olopatadine hydrochloride /ketorolac tromethamine fixed dose combination ophthalmic solution; Drug: olopatadine hydrochloride 0.1% ophthalmic solution

• Registration Number: NCT01258309
• Lead Sponsor: Allergan

Brief Summary

This study will investigate the safety and efficacy of olopatadine hydrochloride / ketorolac tromethamine fixed dose combination ophthalmic solution compared with olopatadine hydrochloride ophthalmic solution in patients with seasonal allergic conjunctivitis.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-09
• Study First Submitted QC: 2010-12-09
• Study First Posted: 2010-12-10
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-24
• Last Update Posted: 2012-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

• Clinical diagnosis of seasonal allergic conjunctivitis

Exclusion Criteria

• Ocular infection or history of ocular herpes infection
• History of retinal detachment or diabetic retinopathy
• Prior or current use of systemic or topical steroids, NSAIDs, anticholinergics, immunosuppressants, or antihistamines
• Ocular surgery within 8 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	olopatadine hydrochloride /ketorolac tromethamine fixed dose combination ophthalmic solution	olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution
2	olopatadine hydrochloride 0.1% ophthalmic solution	olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution

Primary Outcome Measures

Name	Time	Method
Ocular Itching	Day 21

Secondary Outcome Measures

Name	Time	Method
Chemosis	Day 21
Hyperemia	Day 21
Ocular mucous discharge	Day 21