Safety and Comfort of AL-4943A Ophthalmic Solution

Phase 1

Completed

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: Olopatadine hydrochloride ophthalmic solution, 0.7%; Drug: Olopatadine hydrochloride ophthalmic solution vehicle; Drug: Ketotifen fumarate ophthalmic solution, 0.025%

• Registration Number: NCT01326858
• Lead Sponsor: Alcon Research

Brief Summary

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

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2011-03-30
• Study First Submitted QC: 2011-03-30
• Study First Posted: 2011-03-31
• Study Start: 2011-04
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-27
• Last Update Posted: 2015-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Vehicle	Olopatadine hydrochloride ophthalmic solution vehicle	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
Zaditor	Olopatadine hydrochloride ophthalmic solution, 0.7%	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
Zaditor	Ketotifen fumarate ophthalmic solution, 0.025%	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
Olopatadine, 0.7%	Olopatadine hydrochloride ophthalmic solution vehicle	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
Olopatadine, 0.7%	Ketotifen fumarate ophthalmic solution, 0.025%	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
Olopatadine, 0.7%	Olopatadine hydrochloride ophthalmic solution, 0.7%	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
Vehicle	Olopatadine hydrochloride ophthalmic solution, 0.7%	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
Vehicle	Ketotifen fumarate ophthalmic solution, 0.025%	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
Zaditor	Olopatadine hydrochloride ophthalmic solution vehicle	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

Primary Outcome Measures

Name	Time	Method
Peak discomfort score over a 3-minute period after drop instillation	Up to Day 3	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.

Secondary Outcome Measures

Name	Time	Method
Product Acceptability	Up to Day 3	Product Acceptability assessed by the subject after instillation of drop as a single score where 0=very acceptable and 100=not acceptable.
Ocular Symptoms	Up to Day 3	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.