Overview

A Study Of The Safety And Effectiveness Of A New Treatment For Allergic Conjunctivitis

Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
This study will evaluate the safety and efficacy of a new allergy medication
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bausch & Lomb Incorporated
Treatments:
Ketotifen
Vasoconstrictor Agents
Criteria
Inclusion Criteria:

- Be at least 6 years of age, of any race, or either gender.

- Have a positive allergic history of ocular allergies and a positive skin test reaction
to cat hair/dander, ragweed, tree and/or grass pollen within the past 24 months.

- Have a calculated best-corrected visual acuity of 0.6 logMar or better in each eye as
measured using an ETDRS chart.

- Positive bilateral CAC reaction at Visit 1 & 2.

Exclusion Criteria:

- Have any known contraindications, allergies, or sensitivities to the use of any of the
study medications, or their components.

- Any ocular condition that, in the opinion of the investigator, could affect the
subject's safety or trial parameters

- Manifest signs or symptoms of clinically active allergic conjunctivitis in either eye
at the baseline slit-lamp exam of any visit