Safety and Efficacy of Punctum Plug Delivery System in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Glaucoma Clinical Trial

— CORE  

Official title:

A Phase II, Randomized, Masked, Parallel-Group Study of Safety and Preliminary Efficacy of the Punctum Plug Delivery System in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00650702
• Other study ID #: PPL GLAU 02
• Status: Completed
• Phase: Phase 2
• First received: March 27, 2008
• Last updated: September 16, 2013
• Start date: March 2008
• Est. completion date: February 2009

Study information

• Verified date: March 2011
• 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 Punctum Plug Delivery System (PPDS) is safe and effective in controlling intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 yrs with open-angle glaucoma or ocular hypertension

• Subjects who have a best-corrected visual acuity of 20/100 or better.

Exclusion Criteria:

• Uncontrolled medical conditions.

• Subjects who wear contact lenses.

• 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: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), 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 low dose of Latanoprost-PPDS for 4 months or until loss of efficacy
• Latanoprost-PPDS
Control of IOP compared to baseline for the medium dose of Latanoprost-PPDS for 4 months or until loss of efficacy
• Latanoprost-PPDS
Control of IOP compared to baseline for the high dose 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		12 Weeks	No