Olopatadine 0.2% for the Treatment of Allergic Conjunctivitis

Alcon

Status and phase: Completed; Phase 3

Conditions: Allergic Conjunctivitis

Treatments: Drug: Olopatadine Hydrochloride Ophthalmic Solution Vehicle; Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00331500

C-04-60

Details and patient eligibility

About

The purpose of this study is to demonstrate that Olopatadine 0.2% is superior to vehicle in the treatment of the signs and symptoms associated with allergic conjunctivitis or rhinoconjunctivitis.

Enrollment: 287 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of seasonal allergic conjunctivitis or rhinoconjunctivitis, a positive grass antigen challenge reaction (skin test), and a positive response to grass in the Conjunctival Allergen Challenge (CAC) model

Exclusion criteria

• Under 10 years of age

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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287 participants in 2 patient groups, including a placebo group

Olopatadine Hydrochloride 0.2%

Experimental group

Description:

Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop in each eye, once-daily in the morning for 6 weeks

Treatment:

Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%

Vehicle

Placebo Comparator group

Description:

Olopatadine hydrochloride ophthalmic solution vehicle, 1 drop in each eye, once-daily in the morning for 6 weeks

Treatment:

Drug: Olopatadine Hydrochloride Ophthalmic Solution Vehicle