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NCT01258309 Clinical Trial

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

Rhinitis, Allergic, Seasonal Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01258309
Other study ID # Olo-keto/2009
Secondary ID
Status Completed
Phase Phase 3
First received December 9, 2010
Last updated January 24, 2012
Start date December 2010
Est. completion date January 2011

Study information
Verified date January 2012
Source Allergan
Contact n/a
Is FDA regulated No
Health authority India: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 129
Est. completion date January 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ocular Itching Day 21 No
Secondary Hyperemia Day 21 No
Secondary Chemosis Day 21 No
Secondary Ocular mucous discharge Day 21 No
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