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

Phase 3

Completed

Conditions: Allergic Conjunctivitis

Interventions: Drug: Vehicle
Drug: Ketotifen/naphazoline
Drug: Ketotifen
Drug: Naphazoline

Registration Number: NCT00769886

Lead Sponsor: Bausch & Lomb Incorporated

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 144

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle	Vehicle of KetoNaph ophthalmic solution
KetoNaph	Ketotifen/naphazoline	KetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution
Ketotifen	Ketotifen	Ketotifen fumarate 0.025% ophthalmic solution
Naphazoline	Naphazoline	Naphazoline HCl 0.05% ophthalmic solution

Primary Outcome Measures

Name	Time	Method
Ocular Itching	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	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 Outcome Measures

Name	Time	Method
Episcleral Redness	7, 15, and 20 minutes post challenge at 14 days	Episcleral hyperemia (redness) was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were made using a 0-4 scale, allowing 0.5- unit increments, with 0.0 = None and 4.0 = Extremely severe.
Percentage of Eyes With Tearing	7, 15, and 20 minutes post challenge at 14 days	Tearing was evaluated by the subject at 7, 15, and 20 minutes post challenge (absent or present). Tearing was recorded as either absent or present.
Ciliary Redness	7, 15, and 20 minutes post challenge at 14 days	Ciliary hyperemia (redness) was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were made using a 0-4 scale, allowing 0.5- unit increments, with 0.0 = None and 4.0 = Extremely severe.
Percentage of Eyes With Ocular Mucus Drainage	7, 15, and 20 minutes post challenge at 14 days	Ocular mucous discharge was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Mucous discharged was recorded as either absent or present.
Chemosis	7, 15, and 20 minutes post challenge at 14 days	Chemosis was evaluated by the Investigator at 7, 15, and 20 minutes post challenge on a 0-4 numerical analog scale, allowing 0.5-unit increments, where: 0.0 = None and 4.0 = Extremely severe.
Eyelid Swelling	7, 15, and 20 minutes post challenge at 14 days	Lid swelling was evaluated by the subject at 7, 15, and 20 minutes post challenge on a 0- 3 numerical analog scale, with 0.5-unit increments disallowed, where: 0.0 = None and 3.0 = Severe.