Safety and Comfort of AL-4943A Ophthalmic Solution

Alcon Research50 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Allergic Conjunctivitis

Interventions

Olopatadine hydrochloride ophthalmic solution, 0.7%DRUG

Treatment A

Olopatadine hydrochloride ophthalmic solution vehicleDRUG

Treatment B, inactive ingredients used as placebo

Ketotifen fumarate ophthalmic solution, 0.025%DRUG

Treatment C

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Up to Day 3

Secondary Outcomes

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.

Time frame: 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.

Time frame: Up to Day 3

Data from ClinicalTrials.gov

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