Safety and Comfort of AL-4943A Ophthalmic Solution

Study Overview
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Brief Summary
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The purpose of this study is to assess the ocular comfort and safety of olopatadine hydrochloride opthalmic solution. 0.7%.

Detailed Description
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In this 3-treatment, 3-period, 6-sequence crossover study, each subject will receive all 3 products in randomized order, 1 product at a time, with a washout period of 24 hours between treatment periods. Following instillation of study medication, subjects will complete a 3-minute discomfort profile.

Official Title
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A Randomized, Double-Masked, Crossover Study to Evaluate the Safety and Comfort of AL-4943A Ophthalmic Solution, 0.7%

Conditions
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Allergic Conjunctivitis

Intervention / Treatment
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* Drug: Olopatadine hydrochloride ophthalmic solution, 0.7%
* Drug: Olopatadine hydrochloride ophthalmic solution vehicle
* Drug: Ketotifen fumarate ophthalmic solution, 0.025%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to be dosed in both eyes, to follow instructions, and willing and able to attend required study visits. Negative urine pregnancy test if female of childbearing potential and use adequate birth control throughout the study period. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: History or clinical evidence of ocular herpes simplex or ocular herpes zoster infectious disease. History of any clinically significant external ocular disease within 30 days of the start of the study. Presence of active blepharitis, active meibomian gland dysfunction, active rosacea affecting the ocular surface/lid margin, active or chronic follicular conjunctivitis, preauricular adenopathy, or any other ocular or periocular abnormality that may affect the study outcomes. Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Olopatadine, 0.7%<br>Olopatadine hydrochloride ophthalmic solution, 0.7%, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic vehicle and ketotifen fumarate ophthalmic solution, 0.025%, Periods 2 and 3, as randomized | Drug: Olopatadine hydrochloride ophthalmic solution, 0.7%<br>* Treatment A<br>* Other names: AL-4943A;Drug: Olopatadine hydrochloride ophthalmic solution vehicle<br>* Treatment B, inactive ingredients used as placebo<br>Drug: Ketotifen fumarate ophthalmic solution, 0.025%<br>* Treatment C<br>* Other names: Zaditor®;|
| Placebo Comparator: Vehicle<br>Olopatadine hydrochloride ophthalmic solution vehicle, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic solution, 0.7% and ketotifen fumarate ophthalmic solution, 0.025%, Periods 2 and 3, as randomized | Drug: Olopatadine hydrochloride ophthalmic solution, 0.7%<br>* Treatment A<br>* Other names: AL-4943A;Drug: Olopatadine hydrochloride ophthalmic solution vehicle<br>* Treatment B, inactive ingredients used as placebo<br>Drug: Ketotifen fumarate ophthalmic solution, 0.025%<br>* Treatment C<br>* Other names: Zaditor®;|
| Active Comparator: Zaditor<br>Ketotifen fumarate ophthalmic solution, 0.025%, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic solution, 0.7% and olopatadine hydrochloride ophthalmic solution vehicle, Periods 2 and 3, as randomized | Drug: Olopatadine hydrochloride ophthalmic solution, 0.7%<br>* Treatment A<br>* Other names: AL-4943A;Drug: Olopatadine hydrochloride ophthalmic solution vehicle<br>* Treatment B, inactive ingredients used as placebo<br>Drug: Ketotifen fumarate ophthalmic solution, 0.025%<br>* Treatment C<br>* Other names: Zaditor®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak discomfort score over a 3-minute period after drop instillation | Ocular discomfort as measured by Visual Analog Scale (VAS) with 0=none to 50=severe, was assessed by subjects every 30 seconds between 0 to 180 seconds after drop instillation (at 0, 30, 60, 90, 120, 150, and 180 seconds). Peak discomfort (maximum observed VAS discomfort score over the 3-minute period) for each subject in each period was analyzed. | Up to Day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Symptoms | Ocular symptoms (burning, stinging, tearing, blurring, and stickiness) assessed by the subject after instillation of drop as a single score where 0=none to 9=severe. | Up to Day 3 | 
| Product Acceptability | Product Acceptability assessed by the subject after instillation of drop as a single score where 0=very acceptable and 100=not acceptable. | Up to Day 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ocular discomfort, AL-4943A Ophthalmic Solution