Evaluation of Hyperemia With the Use of Ocular Prostaglandin Analogues

NCT ID: NCT00539526

Last Updated: 2019-04-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-09-30

Brief Summary

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This study will evaluate hyperemia and ocular surface tolerability in patients on prostaglandin analogues

Detailed Description

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Conditions

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Open Angle Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

bimatoprost 0.03%

Group Type EXPERIMENTAL

Bimatoprost 0.03%

Intervention Type DRUG

bimatoprost 0.03%, 1 drop nightly for 3 months

2

travoprost 0.004%

Group Type ACTIVE_COMPARATOR

travoprost 0.004%

Intervention Type DRUG

travoprost 0.004% eye drops, 1 drop nightly for 3 months

3

latanoprost 0.005%

Group Type ACTIVE_COMPARATOR

latanoprost 0.005% eye drops

Intervention Type DRUG

latanoprost 0.005%, 1 drop nightly for 3 months

Interventions

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Bimatoprost 0.03%

bimatoprost 0.03%, 1 drop nightly for 3 months

Intervention Type DRUG

travoprost 0.004%

travoprost 0.004% eye drops, 1 drop nightly for 3 months

Intervention Type DRUG

latanoprost 0.005% eye drops

latanoprost 0.005%, 1 drop nightly for 3 months

Intervention Type DRUG

Other Intervention Names

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Lumigan® Travatan® Z Xalatan®

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of open-angle glaucoma (pseudoexfoliative or pigmentary glaucomas are allowed) or ocular hypertension

Exclusion Criteria

* Known contraindication to latanoprost, bimatoprost or travoprost
* Uncontrolled systemic disease
* Active ocular disease other than glaucoma or ocular hypertension
* Pregnant or lactating women or women of childbearing potential NOT utilizing a medically acceptable form of birth control
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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San Diego, California, United States

Site Status

Countries

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United States

References

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Whitson JT, Trattler WB, Matossian C, Williams J, Hollander DA. Ocular surface tolerability of prostaglandin analogs in patients with glaucoma or ocular hypertension. J Ocul Pharmacol Ther. 2010 Jun;26(3):287-92. doi: 10.1089/jop.2009.0134.

Reference Type BACKGROUND
PMID: 20578283 (View on PubMed)

Other Identifiers

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MA-LUM-07-003

Identifier Type: -

Identifier Source: org_study_id

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