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

• Sponsor: Mati Therapeutics Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00650702
• Collaborator: (none)
• Enrollment: 36
• Locations: 8
• Arms: 3
• Duration (Months): 11.1
• Patients Per Site: 4.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma; Ocular Hypertension	Drug: Latanoprost-PPDS; Drug: Latanoprost-PPDS; Drug: Latanoprost-PPDS	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Feb 1, 2009
• Actual Study Completion Date: Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Low Latanoprost-PPDS	Drug: Latanoprost-PPDS; Control of IOP compared to baseline for the low dose of Latanoprost-PPDS for 4 months or until loss of efficacy
Experimental: 2 Medium Latanoprost-PPDS	Drug: Latanoprost-PPDS; Control of IOP compared to baseline for the medium dose of Latanoprost-PPDS for 4 months or until loss of efficacy
Experimental: 3 High Latanoprost-PPDS	Drug: Latanoprost-PPDS; Control of IOP compared to baseline for the high dose of Latanoprost-PPDS for 4 months or until loss of efficacy

Outcome Measures

Primary Outcome Measures

1. IOP change from baseline [12 Weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Artesia	California	United States	90701
2		Sacramento	California	United States	95815
3		Bel Air	Maryland	United States	21014
4		Minneapolis	Minnesota	United States	55404
5		St. Louis	Missouri	United States	63131
6		Lynbrook	New York	United States	11563
7		High Point	North Carolina	United States	27262
8		Philadelphia	Pennsylvania	United States	19148

Sponsors and Collaborators

• Mati Therapeutics Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mati Therapeutics Inc.
• ClinicalTrials.gov Identifier: NCT00650702
• Other Study ID Numbers: PPL GLAU 02
• First Posted: Apr 2, 2008
• Last Update Posted: Sep 19, 2013
• Last Verified: Mar 1, 2011

• Keywords provided by Mati Therapeutics Inc.: glaucoma, ocular hypertension, IOP
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Latanoprost

Study Results

No Results Posted as of Sep 19, 2013