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Completed

NCT Number: NCT01326858

Safety and Comfort of AL-4943A Ophthalmic Solution

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

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Key information

Conditions

Allergic Conjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Olopatadine hydrochloride ophthalmic solution, 0.7%

Drug

Treatment A

Other names: AL-4943A

Olopatadine Hydrochloride Ophthalmic Solution Vehicle

Drug

Treatment B, inactive ingredients used as placebo

Ketotifen fumarate ophthalmic solution, 0.025%

Drug

Treatment C

Other names: Zaditor®

Primary outcomes

  1. Peak discomfort score over a 3-minute period after drop instillation

    Time frame: 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 outcomes

  1. Ocular Symptoms

    Time frame: 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.

  2. Product Acceptability

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 31, 2011
Registry last updated
Mar 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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