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Safety and Efficacy Study of a Eye Drop for Eye Allergy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00889330
Recruitment Status : Completed
First Posted : April 28, 2009
Results First Posted : December 8, 2011
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
Vistakon Pharmaceuticals

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of an anti-allergy eyedrop.

Condition or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: alcaftadine Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : April 2009
Actual Primary Completion Date : May 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Alcaftadine

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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.

  3. 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 ]
    0 to 4 scale, allowing for half increment scores, where 0 indicates "none" and 4 indicates "incapacitating itch with an irresistible urge to rub"

  4. 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 ]
    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.


Other Outcome Measures:
  1. Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day -14 [ Time Frame: Visit 2 (Day -14) pre-allergen challenge ]
    The number of eyes with any change in visual acuity measurements compared to Day -21.

  2. Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge [ Time Frame: Visit 3 (Day 0) pre-dose, pre-allergen challenge ]
    The number of eyes with any change in visual acuity measurements compared to Day -21

  3. Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge [ Time Frame: Visit 4 (Day 14) pre-dose, pre-allergen challenge ]
    The number of eyes with any change in visual acuity measurements compared to Day -21

  4. Number of Eyes With a Undilated Fundoscopy Changes From Visit 1 (Day -21) at Day 14 [ Time Frame: Visit 4 (Day 14) pre-dose, pre-allergen challenge ]
    The number of eyes with any change to the following: Vitreous, Retina, Macula, Choroid, Optic Nerve

  5. Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day -14 [ Time Frame: Visit 2 (Day -14) pre-allergen challenge ]
    The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus

  6. Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge [ Time Frame: Visit 3 (Day 0) pre-dose, pre-allergen challenge ]
    The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus

  7. Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Post-dose, Pre-allergen Challenge [ Time Frame: Visit 3 (Day 0) post-dose, pre-allergen challenge ]
    The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus

  8. Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge [ Time Frame: Visit 4 (Day 14) pre-dose, pre-allergen challenge ]
    The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus

  9. Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Post-dose, Pre-allergen Challenge [ Time Frame: Visit 4 (Day 14) post-dose, pre-allergen challenge ]
    The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00889330


Locations
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United States, Ohio
Fairfield, Ohio, United States
Mason, Ohio, United States
Sponsors and Collaborators
Vistakon Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00889330    
Other Study ID Numbers: 09-003-05
First Posted: April 28, 2009    Key Record Dates
Results First Posted: December 8, 2011
Last Update Posted: March 6, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
 Alcaftadine
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs