We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00836485
First Posted: February 4, 2009
Last Update Posted: May 19, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Senju USA, Inc.
  Purpose
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 (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
Pataday(TM)
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00836485


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

Responsible Party: Takahiro Ogawa, PhD, Senju USA, Inc.
ClinicalTrials.gov Identifier: NCT00836485     History of Changes
Other Study ID Numbers: SNJ-ALK201/08-003-11
First Submitted: February 2, 2009
First Posted: February 4, 2009
Last Update Posted: May 19, 2009
Last Verified: May 2009

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ophthalmic Solutions
Lubricant Eye Drops
Olopatadine Hydrochloride
Ketotifen
Pharmaceutical Solutions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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
Antipruritics
Dermatologic Agents