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
• 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

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Ocular Hypertension (OH)

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