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NCT01481077 Clinical Trial

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

Glaucoma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01481077
Other study ID # PPL GLAU 13
Secondary ID
Status Completed
Phase Phase 2
First received November 25, 2011
Last updated September 19, 2013
Start date November 2011
Est. completion date September 2012

Study information
Verified date September 2013
Source Mati Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 77
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Latanoprost-PPDS
Sustained release for 12 weeks

Locations
Country Name City State
United States Danbury Eye Physicians & Surgeons Danbury Connecticut
United States Glaucoma Consultants of Colorado, PC Denver Colorado
United States Ophthalmology Consultants Inc. Des Peres Missouri
United States Las Vegas Physicians Research Group Henderson Nevada
United States Abrams Eye Institute Las Vegas Nevada
United States University Eye Surgeons Maryville Tennessee
United States Total Eye Care, P.A. Memphis Tennessee
United States Philadelphia Eye Associates Philadelphia Pennsylvania
United States Vold Vision Springdale Arkansas
United States Ophthalmology Associates St. Louis Missouri
United States Comprehensive Eye Care, Ltd Washington Missouri

Sponsors (1)
Lead Sponsor Collaborator
Mati Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary IOP change from baseline 12 weeks to baseline Yes
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