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

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.

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.

Conditions
-----------------
Allergic Conjunctivitis

Intervention / Treatment
-----------------
* Drug: Ketotifen/naphazoline
* Drug: Naphazoline
* Drug: Ketotifen
* Drug: Vehicle


Participation Criteria
=================
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 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.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketotifen/naphazoline<br>Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. | Drug: Ketotifen/naphazoline<br>* One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.<br>|
| Placebo Comparator: Vehicle<br>Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. | Drug: Vehicle<br>* One drop of vehicle ophthalmic solution at visit 3 and visit 4.<br>|
| Active Comparator: Naphazoline<br>Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. | Drug: Naphazoline<br>* One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.<br>|
| Active Comparator: Ketotifen<br>Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. | Drug: Ketotifen<br>* One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Itching | 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 | 3, 5, and 7 minutes post challenge at 14 days | 
| Conjunctival Redness | 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. | 7, 15, and 20 minutes post challenge at 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ciliary Redness | Ciliary hyperemia (redness) was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were made using the same 0-4 scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe. | 7, 15, and 20 minutes post challenge at 14 days | 
| Episcleral Redness | Episcleral hyperemia (redness) was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were made using the same 0-4 scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe. | 7, 15, and 20 minutes post challenge at 14 days | 
| Chemosis | 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. | 7, 15, and 20 minutes post challenge at 14 days | 
| Eyelid Swelling | Lid swelling was evaluated by the participant 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. | 7, 15, and 20 minutes post challenge at 14 days | 
| Percentage of Eyes With hTearing | Tearing was evaluated by the participant at 7, 15, and 20 minutes post challenge. Tearing was recorded as either absent or present. | 7, 15, and 20 minutes post challenge at 14 days | 
| Percentage of Eyes With Ocular Mucus Discharge | 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. | 7, 15, and 20 minutes post challenge at 14 days |