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:
Information provided by:
Senju USA, Inc.
ClinicalTrials.gov Identifier:
NCT00836485
First received: February 2, 2009
Last updated: May 15, 2009
Last verified: May 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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 TBD
  More Information

No publications provided

Responsible Party: Takahiro Ogawa, PhD, Senju USA, Inc.
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ophthalmic Solutions
Ketotifen
Olopatadine
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Histamine H1 Antagonists, Non-Sedating

ClinicalTrials.gov processed this record on August 26, 2014