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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Bausch & Lomb Incorporated
- Enrollment
- 144
- Locations
- 1
- Primary Endpoint
- Ocular Itching
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 6 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- 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
- •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.
Arms & Interventions
KetoNaph
KetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution
Intervention: Ketotifen/naphazoline (Drug)
Naphazoline
Naphazoline HCl 0.05% ophthalmic solution
Intervention: Naphazoline (Drug)
Ketotifen
Ketotifen fumarate 0.025% ophthalmic solution
Intervention: Ketotifen (Drug)
Vehicle
Vehicle of KetoNaph ophthalmic solution
Intervention: Vehicle (Drug)
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 Hyperemia
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)
- Percentage of Eyes With Tearing(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 Ocular Mucus Drainage(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)