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
  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:


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 April 17, 2014