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.

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.

Study Overview

• Status: Terminated
• Conditions: Seasonal Allergic Conjunctivitis to Ragweed
• Intervention / Treatment: Drug: Olopatadine; Drug: Olopatadine

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Cetero Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lower Puncta Delivery	Drug: Olopatadine; low dose; Drug: Olopatadine; high dose
Experimental: Double Puncta Delivery	Drug: Olopatadine; low dose; Drug: Olopatadine; high dose

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Mati Therapeutics Inc.
• Investigators: Study Director: Dipak Panigrahi, MD, QLT Inc.; Principal Investigator: Deepen Patel, MD, Cetero Research, San Antonio

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: January 27, 2011
• First Submitted That Met QC Criteria: January 31, 2011
• First Posted (Estimate): February 1, 2011

Study Record Updates

• Last Update Posted (Estimate): September 17, 2013
• Last Update Submitted That Met QC Criteria: September 16, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Olopatadine Hydrochloride
• Other Study ID Numbers: PP0 AC 01; 141741 (Other Identifier: Health Canada: Therapeutic Products Directorate)