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

Sponsor

Allergan (Industry)

Overall Status

Completed

CT.gov ID

NCT01258309

Collaborator

(none)

129

Enrollment

Location

Arms

Duration (Months)

126.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rhinitis, Allergic, Seasonal Conjunctivitis, Allergic	Drug: olopatadine hydrochloride /ketorolac tromethamine fixed dose combination ophthalmic solution Drug: olopatadine hydrochloride 0.1% ophthalmic solution	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

129 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Dec 1, 2010

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution	Drug: olopatadine hydrochloride /ketorolac tromethamine fixed dose combination ophthalmic solution One drop of olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution administered to each eye, twice daily for 21 days.
Active Comparator: 2 olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution	Drug: olopatadine hydrochloride 0.1% ophthalmic solution One drop of olopatadine hydrochloride 0.1% ophthalmic solution administered to each eye, twice daily for 21 days. Other Names: Patanol®

Arm

Intervention/Treatment

Experimental: 1

olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution

Drug: olopatadine hydrochloride /ketorolac tromethamine fixed dose combination ophthalmic solution

One drop of olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution administered to each eye, twice daily for 21 days.

Active Comparator: 2

olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution

Drug: olopatadine hydrochloride 0.1% ophthalmic solution

One drop of olopatadine hydrochloride 0.1% ophthalmic solution administered to each eye, twice daily for 21 days.

Other Names:

Patanol®

Outcome Measures

Primary Outcome Measures

Ocular Itching [Day 21]

Secondary Outcome Measures

Hyperemia [Day 21]
Chemosis [Day 21]
Ocular mucous discharge [Day 21]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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