Safety and Efficacy of Punctum Plug Delivery System in Subjects With Open-Angle Glaucoma or Ocular Hypertension (CORE)

Mati Therapeutics

Status and phase: Completed; Phase 2

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: Latanoprost-PPDS

Study type: Interventional

Funder types: Industry

Identifiers

NCT00650702

PPL GLAU 02

Details and patient eligibility

About

The purpose of this study is to determine if the Punctum Plug Delivery System (PPDS) is safe and effective in controlling intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Over 18 yrs with open-angle glaucoma or ocular hypertension
• Subjects who have a best-corrected visual acuity of 20/100 or better.

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.
• Subjects who have a history of chronic or recurrent inflammatory eye disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 3 patient groups

1

Experimental group

Description:

Low Latanoprost-PPDS

Treatment:

Drug: Latanoprost-PPDS

Drug: Latanoprost-PPDS

Drug: Latanoprost-PPDS

2

Experimental group

Description:

Medium Latanoprost-PPDS

Treatment:

Drug: Latanoprost-PPDS

Drug: Latanoprost-PPDS

Drug: Latanoprost-PPDS

3

Experimental group

Description:

High Latanoprost-PPDS

Treatment:

Drug: Latanoprost-PPDS

Drug: Latanoprost-PPDS

Drug: Latanoprost-PPDS