Back to resultsEvaluation 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
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ketotifen 4.0% Patch
Placebo
Olopatadine 0.2%
Artificial tears
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis
Eligibility 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
Sites / Locations
- Ora
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Active Comparator
Placebo Comparator
Arm Label
1
2
3
4
Arm Description
Ketotifen 4.0% Patch
Placebo Patch
Pataday(TM)
Placebo eye drops
Outcomes
Primary Outcome Measures
Ocular itching and bulbar conjunctival redness
Secondary Outcome Measures
Ocular: Ciliary, episcleral, and inferior palpebral conjunctival redness; chemosis; lid swelling; tearing; ocular mucous discharge
Nasal: Rhinorrhea; ear or palate pruritis; nasal pruritis; nasal congestion; and a composite score of all nasal symptoms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00836485
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Senju USA, Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Ketotifen 4.0% Patch
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo Patch
Arm Title
3
Arm Type
Active Comparator
Arm Description
Pataday(TM)
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Placebo eye drops
Intervention Type
Drug
Intervention Name(s)
Ketotifen 4.0% Patch
Intervention Description
This investigational drug is a transdermal patch indicated to treat allergic conjunctivitis. Application is intended for overnight wear between 8-10 hours.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The control is a placebo patch that contains only the inactive ingredients of ketotifen.
Intervention Type
Drug
Intervention Name(s)
Olopatadine 0.2%
Other Intervention Name(s)
Pataday(TM)
Intervention Description
1 gtt/eye on two separate occasions
Intervention Type
Drug
Intervention Name(s)
Artificial tears
Intervention Description
1 gtt/eye on two separate occasions
Primary Outcome Measure Information:
Title
Ocular itching and bulbar conjunctival redness
Time Frame
Visit 3 and Visit 4
Secondary Outcome Measure Information:
Title
Ocular: Ciliary, episcleral, and inferior palpebral conjunctival redness; chemosis; lid swelling; tearing; ocular mucous discharge
Time Frame
Visit 3 and Visit 4
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail Torkildsen, MD
Organizational Affiliation
ORA, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
TBD TBD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ora
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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
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