Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis.

Completed · Phase 3

Conditions studied: Allergic Conjunctivitis

In brief

The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.

Key facts

Study ID

NCT00770133

Run by

Bausch & Lomb Incorporated

People needed

141

Starts

2010-02-01

Expected to finish

2010-06-01

Last updated by the study team

2020-10-27

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months.
• Calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using the ETDRS chart.
• Positive bilateral conjunctival allergen challenge(CAC) reaction within 10 minutes of instillation of the last titration of allergen at visit 1.
• Positive bilateral CAC reaction for at least 2 out of 3 time points at visit 2.

You may not qualify if…

• Known contraindications or sensitivities to the study medication or its components.
• Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
• Use of disallowed medications during the period indicated prior to study enrollment or during the study.

Where it is running

• Ophthalmic Research Consultants, Inc. — North Andover, Massachusetts, United States

Full record on ClinicalTrials.gov

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