Evaluation of the Safety and Efficacy of Ketotifen 4.0% Patch as Compared to Placebo Patch, Olopatadine 0.2% Ophthalmic Solution, and Artificial Tears in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis

Phase 2

Completed

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: Ketotifen 4.0% Patch; Drug: Placebo; Drug: Artificial tears; Drug: Olopatadine 0.2%

• Registration Number: NCT00836485
• Lead Sponsor: Senju USA, Inc.

Brief Summary

This is a phase 2 study that will consist of 4 visits over a 5 week period. Drug will be evaluated using the conjunctival allergen challenge model of allergic conjunctivitis.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-02
• Study First Submitted QC: 2009-02-02
• Study First Posted: 2009-02-04
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Disposition First Submitted: 2017-06-05
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-02
• Disposition First Posted: 2023-08-04
• Last Update Posted: 2023-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• 18 years of age of either sex and any race
• positive history of ocular allergies and a positive skin test reaction to cat hair, cat dander, dog dander, grasses, ragweed, trees, dust mites, and/or cockroaches within the past 24 months
• able and willing to avoid all disallowed medication for the washout period and during the study

Exclusion Criteria

• active ocular infection or skin condition
• ocular surgery within the past 3 months
• pregnancy or nursing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Ketotifen 4.0% Patch	Ketotifen 4.0% Patch
2	Placebo	Placebo Patch
4	Artificial tears	Placebo eye drops
3	Olopatadine 0.2%	Pataday(TM)

Primary Outcome Measures

Name	Time	Method
Ocular itching and bulbar conjunctival redness	Visit 3 and Visit 4

Secondary Outcome Measures

Name	Time	Method
Nasal: Rhinorrhea; ear or palate pruritis; nasal pruritis; nasal congestion; and a composite score of all nasal symptoms	Visit 3 and Visit 4
Ocular: Ciliary, episcleral, and inferior palpebral conjunctival redness; chemosis; lid swelling; tearing; ocular mucous discharge	Visit 3 and Visit 4

Trial Locations

Locations (1)

Ora; 🇺🇸 Andover, Massachusetts, United States