Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis.
Information source: Bausch & Lomb, Inc.
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allergic Conjunctivitis
Intervention: Ketotifen/naphazoline (Drug); Ketotifen/naphazoline and Vehicle (Drug); Ketotifen/naphazoline and Naphazoline (Drug); Ketotifen/naphazoline and Ketotifen (Drug); Ketotifen and Ketotifen/naphazoline (Drug); Ketotifen and Vehicle (Drug); Ketotifen and Naphazoline (Drug); Ketotifen (Drug); Naphazoline and Ketotifen/naphazoline (Drug); Naphazoline and Vehicle (Drug); Naphazoline (Drug); Naphazoline and Ketotifen (Drug); Vehicle and Ketotifen/naphazoline (Drug); Vehicle (Drug); Vehicle and Naphazoline (Drug); Vehicle and Ketotifen (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Bausch & Lomb, Inc. Overall contact:
Jennifer Lynch, Phone: (585) 338-6230, Email: jennifer.lynch@bausch.com
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.
Clinical Details
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Ocular itchingConjunctival redness
Secondary outcome: Ciliary and episcleral redness, chemosis, lid swelling, tearing and ocular mucus discharge.
Eligibility
Minimum age: 6 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Jennifer Lynch, Phone: (585) 338-6230, Email: jennifer.lynch@bausch.com
Ophthalmic Research Consultants, Inc., North Andover, Massachusetts, United States
Additional Information
Starting date: January 2010
Ending date: March 2010
Last updated: June 25, 2009
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