Safety and Comfort of AL-4943A Ophthalmic Solution

This study has been completed.

Sponsor:

Information provided by:

Alcon Research

ClinicalTrials.gov Identifier:

NCT01326858

First received: March 30, 2011

Last updated: August 2, 2011

Last verified: August 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	March 30, 2011
Last Updated Date	August 2, 2011
Start Date ^ICMJE	April 2011
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 12, 2011)	Ocular discomfort profile (Measured using Visual Analog Scale) [ Time Frame: Day 1 ] [ Designated as safety issue: No ] Ocular discomfort profile as measured by Visual Analog Scale with 0=none to 50=severe. Peak discomfort score over a 3-minute period after drop instillation is the primary endpoint. Ocular discomfort profile (Measured Using Visual Analog Scale) [ Time Frame: Day 2 ] [ Designated as safety issue: No ] Ocular discomfort profile as measured by Visual Analog Scale with 0=none to 50=severe. Peak discomfort score over a 3-minute period after drop instillation is the primary endpoint. Ocular discomfort profile (Measured Using Visual Analog Scale) [ Time Frame: Day 3 ] [ Designated as safety issue: No ] Ocular discomfort profile as measured by Visual Analog Scale with 0=none to 50=severe. Peak discomfort score over a 3-minute period after drop instillation is the primary endpoint.
Original Primary Outcome Measures ^ICMJE (submitted: March 30, 2011)	Ocular discomfort profile (Measured using Visual Analog Scale) [ Time Frame: Day 1 ] [ Designated as safety issue: No ] Ocular discomfort profile as measured by Visual Analog Scale with 0=none to 50=severe. Peak discomfort score over a 3-minute period after drop instillatiion is the primary endpoint. Ocular discomfort profile (Measured Using Visual Analog Scale) [ Time Frame: Day 2 ] [ Designated as safety issue: No ] Ocular discomfort profile as measured by Visual Analog Scale with 0=none to 50=severe. Peak discomfort score over a 3-minute period after drop instillatiion is the primary endpoint. Ocular discomfort profile (Measured Using Visual Analog Scale) [ Time Frame: Day 3 ] [ Designated as safety issue: No ] Ocular discomfort profile as measured by Visual Analog Scale with 0=none to 50=severe. Peak discomfort score over a 3-minute period after drop instillatiion is the primary endpoint.
Change History	Complete list of historical versions of study NCT01326858 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 30, 2011)	Ocular Symptoms profile: Burning, Stinging, Tearing, Blurring, and Stickiness [ Time Frame: All Visits ] [ Designated as safety issue: No ] Ocular symptoms profile evaluated on Day 1, Day 2, and Day 3. Ocular symptoms include measurements of Burning, Stinging, Tearing, Blurring, and Stickiness as well as Product Acceptability.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Comfort of AL-4943A Ophthalmic Solution
Official Title ^ICMJE	Not Provided
Brief Summary	The purpose of this study is to assess the ocular comfort and safety of AL-4943A opthalmic solution.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator)
Condition ^ICMJE	Ocular Discomfort
Intervention ^ICMJE	Drug: AL-4943A Ophthalmic Solution (Treatment A) One drop in each eye at either Day 1 (Period 1), Day 2 (Period 2) or Day 3 (Period 3) Drug: AL-4943A Ophthalmic Solution Vehicle (Treatment B) One drop in each eye at either Day 1 (Period 1), Day 2 (Period 2) or Day 3 (Period 3). Drug: Ketotifen Fumarate Ophthalmic Solution (Treatment C) One drop in each eye at either Day 1 (Period 1), Day 2 (Period 2) or Day 3 (Period 3)
Study Arm (s)	Experimental: Sequence Group 1 Treatment Arm 1 will either be given Experimental treatment, Active Comparator, or Placebo. In this study arm, treatments are to be administered in this sequence - Treatment A during period 1, Treatment B during period 2, and Treatment C during period 3. Interventions: Drug: AL-4943A Ophthalmic Solution (Treatment A) Drug: AL-4943A Ophthalmic Solution Vehicle (Treatment B) Drug: Ketotifen Fumarate Ophthalmic Solution (Treatment C) Experimental: Sequence Group 2 Treatments administered in this sequence - Treatment A during Period 1, Treatment C during period 2 & Treatment B during period 3. Interventions: Drug: AL-4943A Ophthalmic Solution (Treatment A) Drug: AL-4943A Ophthalmic Solution Vehicle (Treatment B) Drug: Ketotifen Fumarate Ophthalmic Solution (Treatment C) Placebo Comparator: Sequence Group 3 Treatments administered in this sequence - Treatment B during period 1, Treatment A during period 2 & Treatment C during period 3. Interventions: Drug: AL-4943A Ophthalmic Solution (Treatment A) Drug: AL-4943A Ophthalmic Solution Vehicle (Treatment B) Drug: Ketotifen Fumarate Ophthalmic Solution (Treatment C) Placebo Comparator: Sequence Group 4 Treatments administered in this sequence = Treatment B during period 1, Treatment C during period 2 & Treatment A during period 3 Interventions: Drug: AL-4943A Ophthalmic Solution (Treatment A) Drug: AL-4943A Ophthalmic Solution Vehicle (Treatment B) Drug: Ketotifen Fumarate Ophthalmic Solution (Treatment C) Active Comparator: Sequence Group 5 Treatments administered in this sequence - Treatment C during period 1, Treatment A during period 2 & Treatment B during period 3. Interventions: Drug: AL-4943A Ophthalmic Solution (Treatment A) Drug: AL-4943A Ophthalmic Solution Vehicle (Treatment B) Drug: Ketotifen Fumarate Ophthalmic Solution (Treatment C) Active Comparator: Sequence Group 6 Treatments administered in this sequence - Treatment C during period 1, Treatment B during period 2 & Treatment A during period 3. Interventions: Drug: AL-4943A Ophthalmic Solution (Treatment A) Drug: AL-4943A Ophthalmic Solution Vehicle (Treatment B) Drug: Ketotifen Fumarate Ophthalmic Solution (Treatment C)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	42
Completion Date	June 2011
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Male or female subjects, ages 18 years and older, of any race/ethnicity Subjects must be able to be dosed in both eyes, to follow instructions and be willing and able to attend required study visits. Exclusion Criteria: History or clinical evidence of any prior or current 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 (defined as duration of > 4 weeks) follicular conjunctivitis, preauricular adenopathy, or any other ocular or periocular abnormality that may affect the study outcomes.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01326858
Other Study ID Numbers ^ICMJE	C-10-127
Has Data Monitoring Committee	Not Provided
Responsible Party	Abhijit Narvekar, Clinical Trial Manager
Study Sponsor ^ICMJE	Alcon Research
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alcon Research
Verification Date	August 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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