Safety and Comfort of AL-4943A Ophthalmic Solution

Allergic Conjunctivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01326858
• Other study ID #: C-10-127
• Status: Completed
• Phase: Phase 1
• First received: March 30, 2011
• Last updated: February 27, 2015
• Start date: April 2011
• Est. completion date: June 2011

Study information

• Verified date: February 2015
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• Olopatadine hydrochloride ophthalmic solution, 0.7%
Treatment A
• Olopatadine hydrochloride ophthalmic solution vehicle
Treatment B, inactive ingredients used as placebo
• Ketotifen fumarate ophthalmic solution, 0.025%
Treatment C

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No