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.

Condition(s) targeted: Seasonal Allergic Conjunctivitis to Ragweed

Intervention: Olopatadine (Drug); Olopatadine (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Mati Therapeutics Inc.

Official(s) and/or principal investigator(s):
Dipak Panigrahi, MD, Study Director, Affiliation: QLT Inc.
Deepen Patel, MD, Principal Investigator, Affiliation: Cetero Research, San Antonio

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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

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: Change from baseline and observed values in subject rated ocular itching scores compared between lower puncta delivery and double puncta delivery arms

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Cetero Research, Toronto, Ontario, Canada

Starting date: October 2010
Last updated: September 16, 2013