Safety and Efficacy Study of a Eye Drop for Eye Allergy

Phase 3

Completed

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: alcaftadine; Drug: Placebo

• Registration Number: NCT00889330
• Lead Sponsor: Vistakon Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-24
• Study First Submitted QC: 2009-04-27
• Study First Posted: 2009-04-28
• Primary Completion: 2009-05
• Disposition First Submitted: 2010-05-21
• Disposition First Submitted QC: 2010-06-01
• Disposition First Posted: 2010-06-03
• Results First Submitted: 2011-06-24
• Results First Submitted QC: 2011-11-02
• Results First Posted: 2011-12-08
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-18
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
alcaftadine ophthalmic solution	alcaftadine	active treatment: administered as a single one-drop dose in each eye at each visit (Day 0 and Day 14).
inactive ophthalmic solution vehicle	Placebo	Placebo, vehicle: administered as a single one-drop dose in each eye at each visit (Day 0 and Day 14).

Primary Outcome Measures

Name	Time	Method
Ocular Itching at Visit 4 (Day 14) at 7 Minutes Following Allergen Challenge, 15 Minutes Post- Treatment Instillation	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"
Ocular Itching at Visit 3 (Day 0) at 7 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation.	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.
Conjunctival Redness at Visit 4 (Day 14) at 20 Minutes Following Allergen Challenge, 15 Minutes Post Treatment Instillation	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.
Conjunctival Redness at Visit 3 (Day 0) at 20 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation	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.