A Study of the L-PPDS With Adjunctive Xalatan® Eye Drops in Subjects With OH or OAG

Mati Therapeutics

Status and phase: Completed; Phase 2

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Treatments: Drug: Xalatan; Drug: Latanoprost Punctal Plug Delivery System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01037036

PPL GLAU 08

Details and patient eligibility

About

The objective of this study is to investigate how the intraocular pressure (IOP)-lowering effect of the L-PPDS is altered by adjunctive Xalatan therapy.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Over 18 years
• Diagnosed with bilateral Open-Angle Glaucoma or Ocular Hypertension
• Currently on prostaglandin therapy

Exclusion criteria

• Uncontrolled medical conditions
• Subjects who wear contact lenses
• Subjects requiring chronic topical artificial tears, lubricants, and /or - requiring any other chronic topical medications

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Latanoprost Punctal Plug Delivery System followed by Xalatan

Experimental group

Description:

Subjects will have the Latanoprost Punctal Plug Delivery System placed for 4 week or until loss of efficacy. After removal of the Latanoprost Punctal Plug Delivery system, subjects will administer adjunctive Xalatan eye drops once daily for 2 weeks. This is a single arm study.

Treatment:

Drug: Xalatan

Drug: Latanoprost Punctal Plug Delivery System