Safety and Comfort of AL-4943A Ophthalmic Solution

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

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

Study Overview

• Status: Completed
• Conditions: Allergic Conjunctivitis
• Intervention / Treatment: Drug: Olopatadine hydrochloride ophthalmic solution, 0.7%; Drug: Olopatadine hydrochloride ophthalmic solution vehicle; Drug: Ketotifen fumarate ophthalmic solution, 0.025%

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Olopatadine, 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	Drug: Olopatadine hydrochloride ophthalmic solution, 0.7%; Treatment A; Other Names: AL-4943A; Drug: Olopatadine hydrochloride ophthalmic solution vehicle; Treatment B, inactive ingredients used as placebo; Drug: Ketotifen fumarate ophthalmic solution, 0.025%; Treatment C; Other Names: Zaditor®
Placebo Comparator: 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	Drug: Olopatadine hydrochloride ophthalmic solution, 0.7%; Treatment A; Other Names: AL-4943A; Drug: Olopatadine hydrochloride ophthalmic solution vehicle; Treatment B, inactive ingredients used as placebo; Drug: Ketotifen fumarate ophthalmic solution, 0.025%; Treatment C; Other Names: Zaditor®
Active Comparator: Zaditor; 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%; Treatment A; Other Names: AL-4943A; Drug: Olopatadine hydrochloride ophthalmic solution vehicle; Treatment B, inactive ingredients used as placebo; Drug: Ketotifen fumarate ophthalmic solution, 0.025%; Treatment C; Other Names: Zaditor®

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Abhijit Narvekar, MS, MBBS, Alcon Research

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: March 30, 2011
• First Submitted That Met QC Criteria: March 30, 2011
• First Posted (Estimate): March 31, 2011

Study Record Updates

• Last Update Posted (Estimate): March 3, 2015
• Last Update Submitted That Met QC Criteria: February 27, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Ocular discomfort; AL-4943A Ophthalmic Solution
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Histamine H1 Antagonists, Non-Sedating; Ophthalmic Solutions; Pharmaceutical Solutions; Olopatadine Hydrochloride; Ketotifen
• Other Study ID Numbers: C-10-127