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
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.
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: HyperemiaChemosis Ocular mucous discharge
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
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