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

Allergan

Status and phase: Completed; Phase 3

Conditions: Conjunctivitis, Allergic; Rhinitis, Allergic, Seasonal

Treatments: Drug: olopatadine hydrochloride 0.1% ophthalmic solution; Drug: olopatadine hydrochloride /ketorolac tromethamine fixed dose combination ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01258309

Olo-keto/2009

Details and patient eligibility

About

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.

Enrollment: 129 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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129 participants in 2 patient groups

1

Experimental group

Description:

olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution

Treatment:

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

2

Active Comparator group

Description:

olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution

Treatment:

Drug: olopatadine hydrochloride 0.1% ophthalmic solution