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

Information source: Allergan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rhinitis, Allergic, Seasonal; Conjunctivitis, Allergic

Intervention: olopatadine hydrochloride /ketorolac tromethamine fixed dose combination ophthalmic solution (Drug); olopatadine hydrochloride 0.1% ophthalmic solution (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Allergan

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan


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.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Ocular Itching

Secondary outcome:



Ocular mucous discharge


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Bangalore, Karnataka, India
Additional Information

Starting date: December 2010
Last updated: January 24, 2012

Page last updated: August 23, 2015

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