Study of the Effects of Artificial Tears on the Response to the Latanoprost Punctal Plug Delivery System in Subjects With Ocular Hypertension or Open-Angle Glaucoma

Phase 2

Completed

• Conditions: Ocular Hypertension; Glaucoma
• Interventions: Drug: Latanoprost punctal plug; Drug: artificial tears preserved with Benzalkonium Chloride

• Registration Number: NCT00845299
• Lead Sponsor: Mati Therapeutics Inc.

Brief Summary

The purpose of this study is to determine the effect of artificial tears preserved with Benzalkonium Chloride (AT-BAK) on the IOP response to the L-PPDS and to evaluate the safety of the L-PPDS in subjects with OH or OAG following treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-02-16
• Study First Submitted QC: 2009-02-17
• Study First Posted: 2009-02-18
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Disposition First Submitted: 2011-03-01
• Disposition First Submitted QC: 2011-03-01
• Disposition First Posted: 2011-03-16
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-16
• Last Update Posted: 2013-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Over 18 years 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 with a known sensitivity to latanoprost, BAK, or any other products required for the study
• Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic topical medications.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Latanoprost punctal plug	Latanoprost punctal plug and use of artificial tears containing Benzalkonium Chloride
2	Latanoprost punctal plug	Latanoprost punctal plug only
1	artificial tears preserved with Benzalkonium Chloride	Latanoprost punctal plug and use of artificial tears containing Benzalkonium Chloride

Primary Outcome Measures

Name	Time	Method
IOP change from baseline	6 weeks