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.
Overview
- Phase
- Phase 3
- Intervention
- Ketotifen/naphazoline
- Conditions
- Allergic Conjunctivitis
- Sponsor
- Bausch & Lomb Incorporated
- Enrollment
- 141
- Locations
- 1
- Primary Endpoint
- Ocular Itching
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Eligibility 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
- •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.
Arms & Interventions
Ketotifen/naphazoline
Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Intervention: Ketotifen/naphazoline
Vehicle
Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Intervention: Vehicle
Naphazoline
Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Intervention: Naphazoline
Ketotifen
Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Intervention: Ketotifen
Outcomes
Primary Outcomes
Ocular Itching
Time Frame: 3, 5, and 7 minutes post challenge at 14 days
Ocular itching was evaluated by the participant at 3, 5, and 7 minutes post challenge. Assessments were made using a 0-4 numerical analog scale, allowing 0.5-unit increments (but disallowing 0.25-unit increments), where: 0.0=None and 4.0=Incapacitating itch with an irresistible urge to rub
Conjunctival Redness
Time Frame: 7, 15, and 20 minutes post challenge at 14 days
Conjunctival hyperemia was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were completed using a 0-4 numerical analog scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe.
Secondary Outcomes
- Episcleral Redness(7, 15, and 20 minutes post challenge at 14 days)
- Chemosis(7, 15, and 20 minutes post challenge at 14 days)
- Eyelid Swelling(7, 15, and 20 minutes post challenge at 14 days)
- Percentage of Eyes With Ocular Mucus Discharge(7, 15, and 20 minutes post challenge at 14 days)
- Ciliary Redness(7, 15, and 20 minutes post challenge at 14 days)
- Percentage of Eyes With hTearing(7, 15, and 20 minutes post challenge at 14 days)