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Safety and Efficacy Study of a Eye Drop for Eye Allergy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00889330
First received: April 24, 2009
Last updated: December 20, 2011
Last verified: December 2011
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy and safety of an anti-allergy eyedrop.


Condition Intervention Phase
Allergic Conjunctivitis
 Drug: alcaftadine
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Allergy Pinkeye
Drug Information available for: Alcaftadine
U.S. FDA Resources

Further study details as provided by Vistakon Pharmaceuticals:

Primary Outcome Measures:
  • Ocular Itching at Visit 3 (Day 0) at 7 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation. [ Time Frame: Visit 3 (Day 0) 16 hours post-dose, at up to 7 minutes following Allergen Challenge ] [ Designated as safety issue: No ]
    A 0 to 4 scale used, allowing for half increment scores, where 0 indicates "none" and 4 indicates "incapacitating itch with an irresistible urge to rub"; measurement taken at up to 7 minutes following allergen challenge, 16 hours post treatment instillation.

  • Conjunctival Redness at Visit 3 (Day 0) at 20 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation [ Time Frame: Visit 3 (Day 0) At 20 minutes following Allergen Challenge, 16 hours post-treatment ] [ Designated as safety issue: No ]
    A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates "none" and 4 indicates "extremely red"; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation.

  • Ocular Itching at Visit 4 (Day 14) at 7 Minutes Following Allergen Challenge, 15 Minutes Post- Treatment Instillation [ Time Frame: Visit 4 (Day 14) up to 7 minutes following Allergen Challenge ] [ Designated as safety issue: No ]
    0 to 4 scale, allowing for half increment scores, where 0 indicates "none" and 4 indicates "incapacitating itch with an irresistible urge to rub"

  • Conjunctival Redness at Visit 4 (Day 14) at 20 Minutes Following Allergen Challenge, 15 Minutes Post Treatment Instillation [ Time Frame: Visit 4 (Day 14) At 20 minutes following Allergen Challenge ] [ Designated as safety issue: No ]
    A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates "none" and 4 indicates "extremely red"; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation.


Enrollment: 60
Study Start Date: April 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: alcaftadine ophthalmic solution
active treatment: administered as a single one-drop dose in each eye at each visit (Day 0 and Day 14).
 Drug: alcaftadine
0.25% Ophthalmic Solution, one drop in each eye at each of two visits.
Placebo Comparator: inactive ophthalmic solution vehicle
Placebo, vehicle: administered as a single one-drop dose in each eye at each visit (Day 0 and Day 14).
 Drug: Placebo
Vehicle without active, one drop in each eye at each of two visits.

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 10 years of age
  • positive history of ocular allergies
  • positive skin test reaction to allergens.

Exclusion Criteria:

  • known allergy, contraindication, or sensitivities to the use of any of the study medication(s) or their components
  • ocular surgical intervention within three (3) months prior to visit 1 or during the study
  • known history of retinal detachment, diabetic retinopathy, or progressive retinal disease, or glaucoma
  • any other significant illness
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00889330

Locations
United States, Ohio
Fairfield, Ohio, United States
Mason, Ohio, United States
Sponsors and Collaborators
Vistakon Pharmaceuticals
  More Information

No publications provided by Vistakon Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00889330     History of Changes
Other Study ID Numbers: 09-003-05
Study First Received: April 24, 2009
Results First Received: June 24, 2011
Last Updated: December 20, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
 Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on June 18, 2013