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

Glaucoma Clinical Trial

Official title:

An Open-Label, Phase 2 Study 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: NCT00820300
• Other study ID #: PPL GLAU 03
• Status: Completed
• Phase: Phase 2
• First received: January 8, 2009
• Last updated: September 16, 2013
• Start date: January 2009
• Est. completion date: December 2009

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

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

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• Latanoprost-PPDS
Control of IOP compared to baseline for the experimental doses of Latanoprost-PPDS for 4 months or until loss of efficacy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mati Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOP change from baseline		6 weeks	No