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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

This study has been completed.
Information provided by:
Senju USA, Inc. Identifier:
First received: February 2, 2009
Last updated: May 15, 2009
Last verified: May 2009
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 Intervention Phase
Allergic Conjunctivitis
Drug: Ketotifen 4.0% Patch
Drug: Placebo
Drug: Olopatadine 0.2%
Drug: Artificial tears
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Senju USA, Inc.:

Primary Outcome Measures:
  • Ocular itching and bulbar conjunctival redness [ Time Frame: Visit 3 and Visit 4 ]

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

Estimated Enrollment: 120
Study Start Date: February 2009
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Olopatadine 0.2%
1 gtt/eye on two separate occasions
Other Name: Pataday(TM)
Placebo Comparator: 4
Placebo eye drops
Drug: Artificial tears
1 gtt/eye on two separate occasions


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00836485

United States, Massachusetts
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Senju USA, Inc.
Principal Investigator: Gail Torkildsen, MD ORA, Inc.
Principal Investigator: TBD TBD TBD
  More Information

Responsible Party: Takahiro Ogawa, PhD, Senju USA, Inc. Identifier: NCT00836485     History of Changes
Other Study ID Numbers: SNJ-ALK201/08-003-11
Study First Received: February 2, 2009
Last Updated: May 15, 2009

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases
Olopatadine Hydrochloride
Lubricant Eye Drops
Ophthalmic Solutions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmaceutical Solutions
Dermatologic Agents processed this record on April 28, 2017