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.

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.

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01287338

Enrollment

143

Registered

2011-02-01

Start date

2010-10-31

Completion date

2011-01-31

Last updated

2013-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seasonal Allergic Conjunctivitis to Ragweed

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.

Interventions

DRUGOlopatadine

low dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026