Evaluation of Hyperemia With the Use of Ocular Prostaglandin Analogues

April 10, 2019 updated by: Allergan
This study will evaluate hyperemia and ocular surface tolerability in patients on prostaglandin analogues

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
bimatoprost 0.03%
Drug: Bimatoprost 0.03%
bimatoprost 0.03%, 1 drop nightly for 3 months
Other Names:
  • Lumigan®
Active Comparator: 2
travoprost 0.004%
Drug: travoprost 0.004%
travoprost 0.004% eye drops, 1 drop nightly for 3 months
Other Names:
  • Travatan® Z
Active Comparator: 3
latanoprost 0.005%
Drug: latanoprost 0.005% eye drops
latanoprost 0.005%, 1 drop nightly for 3 months
Other Names:
  • Xalatan®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Conjunctival Hyperemia Scores at Month 3
Time Frame: Baseline, Month 3
Change from baseline in mean conjunctival hyperemia scores at month 3. Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia was graded using a 5-point scale in which 0=no redness and +3=deep, diffuse redness. A negative number change from baseline indicates improvement.
Baseline, Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Corneal Staining With Fluorescein at Month 3
Time Frame: Baseline, Month 3
Change from baseline in corneal staining with fluorescein at month 3. The cornea is the transparent front part of the eye which covers the iris and pupil. To detect the presence or absence of corneal puncta (tiny disruptions in the surface of the eye), fluorescein dye is administered into the eye and the eye is graded using a 5-point scale where 0 equals no puncta (best), and 3 equals too many puncta to count (worst). A negative number change from baseline indicates improvement.
Baseline, Month 3
Change From Baseline in Tear Break-Up Time (TBUT) at Month 3
Time Frame: Baseline, Month 3
Change from baseline in TBUT at month 3. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement.
Baseline, Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

October 2, 2007

First Submitted That Met QC Criteria

October 3, 2007

First Posted (Estimate)

October 4, 2007

Study Record Updates

Last Update Posted (Actual)

April 24, 2019

Last Update Submitted That Met QC Criteria

April 10, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA-LUM-07-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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