A Dose Evaluation Study for the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma

Sponsor

Mati Therapeutics Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01481051

Collaborator

(none)

Enrollment

Locations

Duration (Months)

9.5

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy, safety and duration of the L-PPDS (latanoprost punctal plug delivery system) at different dose levels.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Ocular Hypertension (OH)	Drug: Latanoprost-PPDS	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

57 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

PPL GLAU 12: A Phase 2 Dose Evaluation Study for the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Outcome Measures

Primary Outcome Measures

IOP change from baseline [12 weeks to baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 medication conditions

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sall Research Medical Center, Inc	Artesia	California	United States	90701
2	Wolstan & Goldberg Eye Associates	Los Angeles	California	United States	90505
3	West Coast Eye Care Associates	San Diego	California	United States	92115
4	Coastal Research Associates, LLC	Roswell	Georgia	United States	30076
5	R and R Eye Associates	San Antonio	Texas	United States	78229
6	Rocky Mountain Eye Care Associates	Salt Lake City	Utah	United States	84107