Safety and Comfort of AL-4943A Ophthalmic Solution

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01326858
First received: March 30, 2011
Last updated: February 27, 2015
Last verified: February 2015

March 30, 2011
February 27, 2015
April 2011
June 2011   (final data collection date for primary outcome measure)
Peak discomfort score over a 3-minute period after drop instillation [ Time Frame: Up to Day 3 ] [ Designated as safety issue: No ]
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.
  • 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 [ Time Frame: Up to Day 3 ] [ Designated as safety issue: No ]
    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.
  • Product Acceptability [ Time Frame: Up to Day 3 ] [ Designated as safety issue: No ]
    Product Acceptability assessed by the subject after instillation of drop as a single score where 0=very acceptable and 100=not acceptable.
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.
Not Provided
Not Provided
 
Safety and Comfort of AL-4943A Ophthalmic Solution
A Randomized, Double-Masked, Crossover Study to Evaluate the Safety and Comfort of AL-4943A Ophthalmic Solution, 0.7%
The purpose of this study is to assess the ocular comfort and safety of olopatadine hydrochloride opthalmic solution. 0.7%.
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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Allergic Conjunctivitis
  • Drug: Olopatadine hydrochloride ophthalmic solution, 0.7%
    Treatment A
    Other Name: AL-4943A
  • Drug: Olopatadine hydrochloride ophthalmic solution vehicle
    Treatment B, inactive ingredients used as placebo
  • Drug: Ketotifen fumarate ophthalmic solution, 0.025%
    Treatment C
    Other Name: Zaditor®
  • Experimental: Olopatadine, 0.7%
    Olopatadine hydrochloride ophthalmic solution, 0.7%, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic vehicle and ketotifen fumarate ophthalmic solution, 0.025%, Periods 2 and 3, as randomized
    Interventions:
    • Drug: Olopatadine hydrochloride ophthalmic solution, 0.7%
    • Drug: Olopatadine hydrochloride ophthalmic solution vehicle
    • Drug: Ketotifen fumarate ophthalmic solution, 0.025%
  • Placebo Comparator: Vehicle
    Olopatadine hydrochloride ophthalmic solution vehicle, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic solution, 0.7% and ketotifen fumarate ophthalmic solution, 0.025%, Periods 2 and 3, as randomized
    Interventions:
    • Drug: Olopatadine hydrochloride ophthalmic solution, 0.7%
    • Drug: Olopatadine hydrochloride ophthalmic solution vehicle
    • Drug: Ketotifen fumarate ophthalmic solution, 0.025%
  • Active Comparator: Zaditor
    Ketotifen fumarate ophthalmic solution, 0.025%, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic solution, 0.7% and olopatadine hydrochloride ophthalmic solution vehicle, Periods 2 and 3, as randomized
    Interventions:
    • Drug: Olopatadine hydrochloride ophthalmic solution, 0.7%
    • Drug: Olopatadine hydrochloride ophthalmic solution vehicle
    • Drug: Ketotifen fumarate ophthalmic solution, 0.025%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01326858
C-10-127
No
Not Provided
Not Provided
Alcon Research
Alcon Research
Not Provided
Study Director: Abhijit Narvekar, MS, MBBS Alcon Research
Alcon Research
February 2015

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