Trial | NCT00650702  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    latanoprost timolol ...

  • Study Participants

    36
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.
Study Started
Mar 31
2008
Primary Completion
Feb 28
2009
Study Completion
Feb 28
2009
Last Update
Sep 19
2013
Estimate

Drug Latanoprost-PPDS

Control of IOP compared to baseline for the low dose of Latanoprost-PPDS for 4 months or until loss of efficacy

Drug Latanoprost-PPDS

Control of IOP compared to baseline for the medium dose of Latanoprost-PPDS for 4 months or until loss of efficacy

Drug Latanoprost-PPDS

Control of IOP compared to baseline for the high dose of Latanoprost-PPDS for 4 months or until loss of efficacy

1 Experimental

Low Latanoprost-PPDS

2 Experimental

Medium Latanoprost-PPDS

3 Experimental

High Latanoprost-PPDS

Criteria 

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.
No Results Posted