Overview

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

Status:
Completed
Trial end date:
2010-06-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bausch & Lomb Incorporated
Treatments:
Ketotifen
Naphazoline
Ophthalmic Solutions
Pharmaceutical Solutions
Criteria
Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.