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.

Study Overview
=================
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.

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.

Conditions
-----------------
Seasonal Allergic Conjunctivitis to Ragweed

Intervention / Treatment
-----------------
* Drug: Olopatadine
* Drug: Olopatadine


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lower Puncta Delivery<br> | Drug: Olopatadine<br>* low dose<br>|
| Experimental: Double Puncta Delivery<br> | Drug: Olopatadine<br>* high dose<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of olopatadine-PPDS in subjects with seasonal allergic conjunctivitis to ragweed |  | 4 Days | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline and observed values in subject rated ocular itching scores compared between lower puncta delivery and double puncta delivery arms |  | 4 |