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

Sponsor

Senju USA, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00836485

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Days)

130.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Allergic Conjunctivitis	Drug: Ketotifen 4.0% Patch Drug: Placebo Drug: Olopatadine 0.2% Drug: Artificial tears	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Prospective, Multi-Center, Double-Masked, Randomized, Placebo-Controlled 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

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Ketotifen 4.0% Patch	Drug: Ketotifen 4.0% Patch This investigational drug is a transdermal patch indicated to treat allergic conjunctivitis. Application is intended for overnight wear between 8-10 hours.
Placebo Comparator: 2 Placebo Patch	Drug: Placebo The control is a placebo patch that contains only the inactive ingredients of ketotifen.
Active Comparator: 3 Pataday(TM)	Drug: Olopatadine 0.2% 1 gtt/eye on two separate occasions Other Names: Pataday(TM)
Placebo Comparator: 4 Placebo eye drops	Drug: Artificial tears 1 gtt/eye on two separate occasions

Outcome Measures

Primary Outcome Measures

Ocular itching and bulbar conjunctival redness [Visit 3 and Visit 4]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ora	Andover	Massachusetts	United States	01810

Sponsors and Collaborators

Senju USA, Inc.

Investigators

Principal Investigator: Gail Torkildsen, MD, ORA, Inc.
Principal Investigator: TBD TBD,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00836485

Other Study ID Numbers:

SNJ-ALK201/08-003-11

First Posted:

Feb 4, 2009

Last Update Posted:

May 19, 2009

Last Verified:

May 1, 2009

Additional relevant MeSH terms:

Conjunctivitis

Conjunctivitis, Allergic

Olopatadine Hydrochloride

Ketotifen

Lubricant Eye Drops

Study Results

No Results Posted as of May 19, 2009