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

Mati Therapeutics

Status and phase: Completed; Phase 2

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: Latanoprost-PPDS

Study type: Interventional

Funder types: Industry

Identifiers

NCT00820300

PPL GLAU 03

Details and patient eligibility

About

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

Enrollment: 113 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Subjects who wear contact lenses.
• Uncontrolled medical conditions
• 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: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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113 participants in 1 patient group

Punctal plug

Experimental group

Treatment:

Drug: Latanoprost-PPDS