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.

This study has been terminated.
(Lack of definitive clinical results.)
Sponsor:
Information provided by (Responsible Party):
Mati Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01287338
First received: January 27, 2011
Last updated: September 16, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Seasonal Allergic Conjunctivitis to Ragweed
Drug: Olopatadine
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Mati Therapeutics Inc.:

Primary Outcome Measures:
  • Safety of olopatadine-PPDS in subjects with seasonal allergic conjunctivitis to ragweed [ Time Frame: 4 Days ] [ Designated as safety issue: Yes ]
  • Change from baseline in subject-rated ocular itching scores in treated vs placebo control arms in subjects with seasonal allergic conjunctivitis to ragweed [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline and observed values in subject rated ocular itching scores compared between lower puncta delivery and double puncta delivery arms [ Time Frame: 4 ] [ Designated as safety issue: No ]

Enrollment: 143
Study Start Date: October 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lower Puncta Delivery Drug: Olopatadine
low dose
Experimental: Double Puncta Delivery Drug: Olopatadine
high dose

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287338

Locations
Canada, Ontario
Cetero Research
Toronto, Ontario, Canada
Sponsors and Collaborators
Mati Therapeutics Inc.
Investigators
Study Director: Dipak Panigrahi, MD QLT Inc.
Principal Investigator: Deepen Patel, MD Cetero Research, San Antonio
  More Information

No publications provided

Responsible Party: Mati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01287338     History of Changes
Other Study ID Numbers: PP0 AC 01, 141741
Study First Received: January 27, 2011
Last Updated: September 16, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Olopatadine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Allergic Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 21, 2014