A Dose Evaluation Study of the Effect of Plug Placement on the Efficacy and Safety of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma
This study has been completed.
Sponsor:
QLT Inc.
Information provided by (Responsible Party):
QLT Inc.
ClinicalTrials.gov Identifier:
NCT01481077
First received: November 25, 2011
Last updated: October 3, 2012
Last verified: October 2012
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Purpose
The purpose of this study is to determine the effect of plug placement on the efficacy, safety and duration of effect of the L-PPDS (latanoprost punctal plug delivery system).
| Condition | Intervention | Phase |
|---|---|---|
|
Glaucoma Ocular Hypertension (OH) |
Drug: Latanoprost |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | PPL GLAU 13: A Randomized Phase 2 Study of the Effect of Plug Placement on Efficacy and Safety of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG) |
Resource links provided by NLM:
Genetics Home Reference related topics:
early-onset glaucoma
Drug Information available for:
Latanoprost
U.S. FDA Resources
Further study details as provided by QLT Inc.:
Primary Outcome Measures:
- IOP change from baseline [ Time Frame: 12 weeks to baseline ] [ Designated as safety issue: Yes ]
| Enrollment: | 81 |
| Study Start Date: | November 2011 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Treatment A |
Drug: Latanoprost
Sustained release for 12 weeks
|
| Experimental: Treatment B |
Drug: Latanoprost
Sustained release for 12 weeks
|
| Experimental: Treatment C |
Drug: Latanoprost
Sustained release for 12 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female at least 18 years old
- Diagnosis of bilateral open angle glaucoma or ocular hypertension
- Unmedicated IOP must be ≥22mm Hg
Exclusion Criteria:
- Any significant vision loss in the last year
- No contact lens use for the length of the study
- Abnormal eye lids, eye infection or diseases to the eye
- Recent eye surgery
- Uncontrolled medical conditions
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01481077
Locations
| United States, Arkansas | |
| Vold Vision | |
| Springdale, Arkansas, United States, 72762 | |
| United States, Colorado | |
| Glaucoma Consultants of Colorado, PC | |
| Denver, Colorado, United States, 80134 | |
| United States, Connecticut | |
| Danbury Eye Physicians & Surgeons | |
| Danbury, Connecticut, United States, 06810 | |
| United States, Missouri | |
| Ophthalmology Consultants Inc. | |
| Des Peres, Missouri, United States, 63131 | |
| Ophthalmology Associates | |
| St. Louis, Missouri, United States, 63131 | |
| Comprehensive Eye Care, Ltd | |
| Washington, Missouri, United States, 63090 | |
| United States, Nevada | |
| Las Vegas Physicians Research Group | |
| Henderson, Nevada, United States, 89052 | |
| Abrams Eye Institute | |
| Las Vegas, Nevada, United States, 89148 | |
| United States, Pennsylvania | |
| Philadelphia Eye Associates | |
| Philadelphia, Pennsylvania, United States, 19148 | |
| United States, Tennessee | |
| University Eye Surgeons | |
| Maryville, Tennessee, United States, 37803 | |
| Total Eye Care, P.A. | |
| Memphis, Tennessee, United States, 38119 | |
Sponsors and Collaborators
QLT Inc.
Investigators
| Study Director: | Suzanne Cadden | QLT Inc. |
More Information
No publications provided
| Responsible Party: | QLT Inc. |
| ClinicalTrials.gov Identifier: | NCT01481077 History of Changes |
| Other Study ID Numbers: | PPL GLAU 13 |
| Study First Received: | November 25, 2011 |
| Last Updated: | October 3, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Glaucoma Glaucoma, Open-Angle Hypertension Ocular Hypertension Eye Diseases Vascular Diseases |
Cardiovascular Diseases Latanoprost Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013