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NCT00375596 Clinical Trial

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

Allergic Conjunctivitis Clinical Trial

Official title:
Study Withdrawn Prior to Determining Official Title

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00375596
Other study ID # C-02-06-001
Secondary ID
Status Withdrawn
Phase Phase 2
First received September 12, 2006
Last updated February 19, 2015

Study information
Verified date February 2015
Source Bausch & Lomb Incorporated
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This study will evaluate the safety and efficacy of a new allergy medication

Description:

Study withdrawn prior to determining study details

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 6 Years and older
Eligibility 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

Study Design

Intervention Model: Parallel Assignment

Related Conditions & MeSH terms

Intervention

Drug:
• Ketotifen/vasoconstrictor

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bausch & Lomb Incorporated

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and efficacy of a new allergy medication STUDY WITHDRAWN PRIOR TO OUTCOME DETERMINATION 0 No
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