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
  Purpose

The purpose of this study is to assess the ocular comfort and safety of olopatadine hydrochloride opthalmic solution. 0.7%.


Condition Intervention Phase
Allergic Conjunctivitis
Drug: Olopatadine hydrochloride ophthalmic solution, 0.7%
Drug: Olopatadine hydrochloride ophthalmic solution vehicle
Drug: Ketotifen fumarate ophthalmic solution, 0.025%
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Randomized, Double-Masked, Crossover Study to Evaluate the Safety and Comfort of AL-4943A Ophthalmic Solution, 0.7%

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 50
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: 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
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®
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
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®
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
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®

Detailed Description:

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.

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Abhijit Narvekar, MS, MBBS Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01326858     History of Changes
Other Study ID Numbers: C-10-127
Study First Received: March 30, 2011
Last Updated: February 27, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alcon Research:
Ocular discomfort
AL-4943A Ophthalmic Solution

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Ketotifen
Olopatadine
Ophthalmic Solutions
Pharmaceutical Solutions
Analgesics
Analgesics, Non-Narcotic
Anti-Allergic Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipruritics
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on May 28, 2015