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

NCT01229982 | Completed Phase 2

• 1 other identifier: PPL GLAU 11
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ocular Hypertension; Open Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

• IOP change from baseline at 4 weeks

  4 Weeks minus baseline

  Baseline to 4 Weeks

Study Arms (1)

L-PPDS

EXPERIMENTAL

Drug: Latanoprost-PPDS

Interventions

Latanoprost-PPDS DRUG

Punctal Plug

L-PPDS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mati Therapeutics Inc.: lead

Study Sites (1)

QLT Inc.

Vancouver, British Columbia, V5T 4T5, Canada

Location

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Eye Diseases; Glaucoma

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2010
• First Posted: October 28, 2010
• Study Start: October 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: September 19, 2013

Record last verified: 2013-09

Locations

CA (1)