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:
QLT Inc.
Information provided by:
QLT Inc.
ClinicalTrials.gov Identifier:
NCT01287338
First received: January 27, 2011
Last updated: June 23, 2011
Last verified: June 2011
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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 QLT 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 |
| Estimated Study Completion Date: | July 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
QLT 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: | Dipak Panigrahi, MD, QLT Plug Delivery Inc. |
| ClinicalTrials.gov Identifier: | NCT01287338 History of Changes |
| Other Study ID Numbers: | PP0 AC 01, 141741 |
| Study First Received: | January 27, 2011 |
| Last Updated: | June 23, 2011 |
| 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 May 16, 2013