Safety and Comfort of AL-4943A Ophthalmic Solution - Full Text View

Purpose

The purpose of this study is to assess the ocular comfort and safety of AL-4943A opthalmic solution.

Condition	Intervention	Phase
Ocular Discomfort	Drug: AL-4943A Ophthalmic Solution (Treatment A) Drug: AL-4943A Ophthalmic Solution Vehicle (Treatment B) Drug: Ketotifen Fumarate Ophthalmic Solution (Treatment C)	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator)

Resource links provided by NLM:

Drug Information available for: Ketotifen Ketotifen fumarate Olopatadine Olopatadine hydrochloride

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.

Estimated Enrollment:	42
Study Start Date:	April 2011
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	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)
Experimental: Sequence Group 2 Treatments administered in this sequence - Treatment A during Period 1, Treatment C during period 2 & Treatment B during period 3.	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)
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.	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)
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	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)
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.	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)
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.	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)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326858

Locations

United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

More Information

No publications provided

Responsible Party:	Abhijit Narvekar, Clinical Trial Manager
ClinicalTrials.gov Identifier:	NCT01326858 History of Changes
Other Study ID Numbers:	C-10-127
Study First Received:	March 30, 2011
Last Updated:	August 2, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alcon Research:

ocular discomfort
AL-4943A Ophthalmic Solution

Additional relevant MeSH terms:

Ketotifen
Olopatadine
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013