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

March 30, 2011
August 2, 2011
April 2011
June 2011   (final data collection date for primary outcome measure)
  • 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.
  • 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.
Complete list of historical versions of study NCT01326858 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Safety and Comfort of AL-4943A Ophthalmic Solution
Not Provided

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Ocular Discomfort
  • 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 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01326858
C-10-127
Not Provided
Abhijit Narvekar, Clinical Trial Manager
Alcon Research
Not Provided
Not Provided
Alcon Research
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP