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Completed

NCT Number: NCT00889330

Safety and Efficacy Study of a Eye Drop for Eye Allergy

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

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Key information

Conditions

Allergic Conjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fairfield, Ohio, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

alcaftadine

Drug

0.25% Ophthalmic Solution, one drop in each eye at each of two visits.

Placebo

Drug

Vehicle without active, one drop in each eye at each of two visits.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Vistakon Pharmaceuticals

Industry

Registry information

Important dates

Study start
2009
Primary completion
2009
First posted
Apr 28, 2009
Registry last updated
Mar 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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