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

Official Title: “A Multi-center, Double-masked, Randomized, Placebo-controlled Evaluation of the Onset and Duration of Action of KetoNaph Ophthalmic Solution in the Conjunctival Allergen Challenge (CAC) 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 fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.
• Drug: Naphazoline
  • One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.
• Drug: Ketotifen
  • One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.
• Drug: Vehicle
  • One drop of vehicle ophthalmic solution at visit 3 and visit 4.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Ketotifen/naphazoline
  • Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
• Placebo Comparator: Vehicle
  • Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
• Active Comparator: Naphazoline
  • Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
• Active Comparator: Ketotifen
  • Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.

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 and ocular mucus discharge.
  • 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 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.

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

Overall Clinical Trial Officials and Contacts

Laura Trusso Study Director Bausch & Lomb, Inc.  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00770133

Study ID Number: 572

ClinicalTrials.gov Identifier: NCT00770133

Health Authority: United States: Food and Drug Administration