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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

NCT ID: NCT00845299

Last Updated: 2013-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-12-31

Brief Summary

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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

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Conditions

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Glaucoma Ocular Hypertension

Keywords

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glaucoma ocular hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Latanoprost punctal plug and use of artificial tears containing Benzalkonium Chloride

Group Type EXPERIMENTAL

Latanoprost punctal plug

Intervention Type DRUG

Control of IOP compared to baseline for the experimental dose of Latanoprost punctal plug for 6 weeks or until loss of efficacy.

artificial tears preserved with Benzalkonium Chloride

Intervention Type DRUG

2

Latanoprost punctal plug only

Group Type EXPERIMENTAL

Latanoprost punctal plug

Intervention Type DRUG

Control of IOP compared to baseline for the experimental dose of Latanoprost punctal plug for 6 weeks or until loss of efficacy.

Interventions

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Latanoprost punctal plug

Control of IOP compared to baseline for the experimental dose of Latanoprost punctal plug for 6 weeks or until loss of efficacy.

Intervention Type DRUG

artificial tears preserved with Benzalkonium Chloride

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mati Therapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oscar Cuzzani, MD

Role: STUDY_DIRECTOR

QLT Inc.

Locations

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Menlo Park, California, United States

Site Status

Countries

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United States

Other Identifiers

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PPL GLAU 04

Identifier Type: -

Identifier Source: org_study_id