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

Glaucoma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01481051
• Other study ID #: PPL GLAU 12
• 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 evaluate the efficacy, safety and duration of the L-PPDS (latanoprost punctal plug delivery system) at different dose levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• 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 medication conditions

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group 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 delivery for 12 weeks

Locations

Country	Name	City	State
United States	Sall Research Medical Center, Inc	Artesia	California
United States	Wolstan & Goldberg Eye Associates	Los Angeles	California
United States	Coastal Research Associates, LLC	Roswell	Georgia
United States	Rocky Mountain Eye Care Associates	Salt Lake City	Utah
United States	R and R Eye Associates	San Antonio	Texas
United States	West Coast Eye Care Associates	San Diego	California

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