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

Bausch + Lomb

Status and phase: Completed; Phase 3

Conditions: Allergic Conjunctivitis

Treatments: Drug: Vehicle; Drug: Ketotifen/naphazoline; Drug: Naphazoline; Drug: Ketotifen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00769886

571

Details and patient eligibility

About

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.

Enrollment: 144 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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144 participants in 4 patient groups, including a placebo group

KetoNaph

Experimental group

Description:

KetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution

Treatment:

Drug: Ketotifen/naphazoline

Naphazoline

Active Comparator group

Description:

Naphazoline HCl 0.05% ophthalmic solution

Treatment:

Drug: Naphazoline

Ketotifen

Active Comparator group

Description:

Ketotifen fumarate 0.025% ophthalmic solution

Treatment:

Drug: Ketotifen

Vehicle

Placebo Comparator group

Description:

Vehicle of KetoNaph ophthalmic solution

Treatment:

Drug: Vehicle