A Study Evaluating 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

Open Angle Glaucoma

Ocular Hypertension

Treatments

Drug: Latanoprost-PPDS

Study type

Interventional

Funder types

Industry

Identifiers

NCT01229982

PPL GLAU 11

Details and patient eligibility

About

The purpose of this study is to test if latanoprost punctal plugs will reduce eye pressure in subjects with ocular hypertension or open-angle glaucoma.

Enrollment

121 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosed with bilateral OH or OAG and on topical prostaglandin monotherapy bilaterally as standard of care for treatment of OH or OAG.
Adequate IOP control on topical prostaglandin monotherapy during the past 1 month.

Exclusion criteria

Functionally significant vision loss, or progressive field loss within the last year.
Contact lens wear at any time during the treatment period.
Keratoconjunctivitis sicca requiring chronic topical artificial tears, lubricants, and/or Restasis®.
Active lid disease (i.e., moderate or severe blepharitis, meibomianitis) that requires medical treatment.
Subjects with ≥0.9 vertical cup or completely notched optic nerve head rim.
Currently on chronic ocular topical medications
Currently on any ophthalmic or systemic steroid therapy.
Laser surgery for glaucoma within the last 3 months or 6 months for incisional surgeries.
History of macular edema
History of chronic/recurrent inflammatory eye disease.
History of a non-response to topical prostaglandin therapy.
Subjects who have epiphora.