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NCT01229982 Clinical Trial

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

Ocular Hypertension Clinical Trial

Official title:
A Phase 2 Study Evaluating Safety and Efficacy of the Latanoprost Punctal Plug Delivery System (L PPDS)in Subjects With Ocular Hypertension (OH) or Open Angle Glaucoma (OAG)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01229982
Other study ID # PPL GLAU 11
Secondary ID
Status Completed
Phase Phase 2
First received October 27, 2010
Last updated September 16, 2013
Start date October 2010
Est. completion date August 2011

Study information
Verified date September 2013
Source Mati Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 121
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Latanoprost-PPDS
Punctal Plug

Locations
Country Name City State
Canada QLT Inc. Vancouver British Columbia

Sponsors (1)
Lead Sponsor Collaborator
Mati Therapeutics Inc.

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary IOP change from baseline at 4 weeks 4 Weeks minus baseline Baseline to 4 Weeks Yes
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