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

Official Title: “A Multi-Center, Double-Masked, Randomized, Vehicle and Active Controlled Evaluation of the Onset and Duration of Action of KetoNaph Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis”

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.

Intervention(s) in this Clinical Trial

• Drug: Ketotifen/naphazoline
  • One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4.
• Drug: Ketotifen
  • One drop of Ketotifen in study eye at visit 3 and visit 4.
• Drug: Naphazoline
  • One drop of naphazoline in study eye at vist 3 and visit 4.
• Drug: Vehicle
  • One drop of vehicle in study eye at visit 3 and visit 4.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: KetoNaph
  • KetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution
• Active Comparator: Naphazoline
  • Naphazoline HCl 0.05% ophthalmic solution
• Active Comparator: Ketotifen
  • Ketotifen fumarate 0.025% ophthalmic solution
• Placebo Comparator: Vehicle
  • Vehicle of KetoNaph ophthalmic solution

Primary Measures

• Ocular itching
  • Time Frame: 3, 5 and 7 minutes post-challenge
    Safety Issue?: No
• Conjunctival redness
  • Time Frame: 7, 15 and 20 minutes post-challenge
    Safety Issue?: No

Secondary Measures

• Ciliary and episcleral redness, chemosis, lid swelling, tearing, ocular mucus drainage
  • Time Frame: 7, 15 and 20 minutes post challenge
    Safety Issue?: No

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 in 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Bausch & Lomb, Inc. Industry

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00769886

Study ID Number: 571

ClinicalTrials.gov Identifier: NCT00769886

Health Authority: United States: Food and Drug Administration