Back to resultsA Study to Evaluate the Safety and Efficacy of the QLT Proprietary Olopatadine-PPDS in Subjects With Seasonal Allergic Conjunctivitis to Ragweed in an Environmental Exposure Chamber Model.
Primary Purpose
Seasonal Allergic Conjunctivitis to Ragweed
Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Olopatadine
Olopatadine
Sponsored by
About this trial
This is an interventional treatment trial for Seasonal Allergic Conjunctivitis to Ragweed
Eligibility Criteria
Inclusion Criteria:
- History of allergic conjunctivitis to ragweed for at least one year
- Positive skin prick test to ragweed pollen within 12 months prior to visit 1
- BCVA of at leat 20/400
Exclusion Criteria:
- Structural lid abnormalities (ectropion, entropion)
- Active lid disease ( ie moderate or severe blepharitis, meibomianitis) that requires medical treatment
- Presence of follicular conjunctivitis, anterior uveitis or preauricular lymphadenopathy
- History of ophthalmic abnormality, including a history of dry eye
- Perennial allergic rhinoconjunctivitis having significant allergy to animal dander that cannot be avoided during the study period
- History of chronic bacterial or viral ocular infection, such as herpes keratitis, and/or presence of active bacterial or viral ocular infection
- presence of mucous discharge, excess lacrimation or burning as a symptoms of ocular disease
- Currently on any chronic ocular topical medications
- Use of topical or systemic ocular medications during the study period
- History of complications, adverse events, trauma or disease in the nasolacrimal area
- History of symptomatic epiphoria
Sites / Locations
- Cetero Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Lower Puncta Delivery
Double Puncta Delivery
Arm Description
Outcomes
Primary Outcome Measures
Safety of olopatadine-PPDS in subjects with seasonal allergic conjunctivitis to ragweed
Change from baseline in subject-rated ocular itching scores in treated vs placebo control arms in subjects with seasonal allergic conjunctivitis to ragweed
Secondary Outcome Measures
Change from baseline and observed values in subject rated ocular itching scores compared between lower puncta delivery and double puncta delivery arms
Full Information
NCT ID
NCT01287338
First Posted
January 27, 2011
Last Updated
September 16, 2013
Sponsor
Mati Therapeutics Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01287338
Brief Title
A Study to Evaluate the Safety and Efficacy of the QLT Proprietary Olopatadine-PPDS in Subjects With Seasonal Allergic Conjunctivitis to Ragweed in an Environmental Exposure Chamber Model.
Official Title
A Randomized, Double-Masked, Placebo-Controlled, Proof of Concept Study to Evaluate the Short-term Safety and Efficacy of the QLT Proprietary Olopatadine Punctal Plug Delivery System in Subjects With Seasonal Allergic Conjunctivitis to Ragweed in an Environmental Exposure Chamber Model.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Terminated
Why Stopped
Lack of definitive clinical results.
Study Start Date
October 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mati Therapeutics Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to test if olopatadine punctal plugs can reduce the symptoms (itching) of allergic conjunctivitis to ragweed in an Environmental Exposure Chamber model.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Conjunctivitis to Ragweed
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lower Puncta Delivery
Arm Type
Experimental
Arm Title
Double Puncta Delivery
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Olopatadine
Intervention Description
low dose
Intervention Type
Drug
Intervention Name(s)
Olopatadine
Intervention Description
high dose
Primary Outcome Measure Information:
Title
Safety of olopatadine-PPDS in subjects with seasonal allergic conjunctivitis to ragweed
Time Frame
4 Days
Title
Change from baseline in subject-rated ocular itching scores in treated vs placebo control arms in subjects with seasonal allergic conjunctivitis to ragweed
Time Frame
4 days
Secondary Outcome Measure Information:
Title
Change from baseline and observed values in subject rated ocular itching scores compared between lower puncta delivery and double puncta delivery arms
Time Frame
4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
History of allergic conjunctivitis to ragweed for at least one year
Positive skin prick test to ragweed pollen within 12 months prior to visit 1
BCVA of at leat 20/400
Exclusion Criteria:
Structural lid abnormalities (ectropion, entropion)
Active lid disease ( ie moderate or severe blepharitis, meibomianitis) that requires medical treatment
Presence of follicular conjunctivitis, anterior uveitis or preauricular lymphadenopathy
History of ophthalmic abnormality, including a history of dry eye
Perennial allergic rhinoconjunctivitis having significant allergy to animal dander that cannot be avoided during the study period
History of chronic bacterial or viral ocular infection, such as herpes keratitis, and/or presence of active bacterial or viral ocular infection
presence of mucous discharge, excess lacrimation or burning as a symptoms of ocular disease
Currently on any chronic ocular topical medications
Use of topical or systemic ocular medications during the study period
History of complications, adverse events, trauma or disease in the nasolacrimal area
History of symptomatic epiphoria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dipak Panigrahi, MD
Organizational Affiliation
QLT Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Deepen Patel, MD
Organizational Affiliation
Cetero Research, San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cetero Research
City
Toronto
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety and Efficacy of the QLT Proprietary Olopatadine-PPDS in Subjects With Seasonal Allergic Conjunctivitis to Ragweed in an Environmental Exposure Chamber Model.
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