Seasonal Allergic Conjunctivitis to Ragweed Clinical Trial
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.
| Verified date | September 2013 |
| Source | Mati Therapeutics Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Health Canada |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 143 |
| Est. completion date | January 2011 |
| Est. primary completion date | January 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Cetero Research | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| Mati Therapeutics Inc. |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety of olopatadine-PPDS in subjects with seasonal allergic conjunctivitis to ragweed | 4 Days | Yes | |
| Primary | Change from baseline in subject-rated ocular itching scores in treated vs placebo control arms in subjects with seasonal allergic conjunctivitis to ragweed | 4 days | No | |
| Secondary | Change from baseline and observed values in subject rated ocular itching scores compared between lower puncta delivery and double puncta delivery arms | 4 | No |