Trusopt and Cosopt; Ocular Perfusion Pressure and Blood Flow: New Long-term Prospective Data

NCT ID: NCT01145898

Last Updated: 2014-01-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To analyze Cosopt® in terms of its effects on ocular perfusion pressure and comprehensive ocular blood flow and in relation to visual field progression and optic nerve structural changes in an ongoing 3 year prospective study involving 120 patients with open angle glaucoma.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

To analyze Cosopt® in terms of its effects on ocular perfusion pressure and comprehensive ocular blood flow and in relation to visual field progression and optic nerve structural changes in an ongoing 3 year prospective study involving 120 patients with open angle glaucoma.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glaucoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Glaucoma patients

Patients with Glaucoma

(Cosopt®, prostaglandin)

Intervention Type DRUG

We did NOT provide any intervention, we observed groups of patients already on these drugs as observers only.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

(Cosopt®, prostaglandin)

We did NOT provide any intervention, we observed groups of patients already on these drugs as observers only.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cosopt is a trade name drug which is a combination of dorzolamide and timolol.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age: 30 years or older.
2. Diagnosis: confirmed open-angle glaucoma in at least one eye:

1. glaucomatous visual field loss on Humphrey 24-2 or 10-2 perimetry
2. glaucomatous optic disc cupping
3. agreement between two baseline exams for reliability
3. Best corrected visual acuity at least 20/60 in at least one eye.
4. Prior Humphrey visual fields demonstrate acceptable reliability standards.

Exclusion Criteria

1. Extensive Humphrey visual field damage consisting of either a mean deviation (MD) \< -15 decibels or a clinically determined threat to fixation in both hemifields.
2. Evidence of exfoliation or pigment dispersion.
3. History of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy.
4. History of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis).
5. History or signs of intraocular trauma.
6. Severe or potentially progressive retinal disease such as retinal degeneration, diabetic retinopathy, and retinal detachment.
7. Any abnormality preventing reliable applanation tonometry.
8. Current use of any ophthalmic or systemic steroid which may interfere with this investigation.
9. Cataract surgery within the past year.
10. Resting pulse \< 50 beats per minute.
11. Severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Indiana University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alon Harris, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Indiana University School of Medicine, Department of Ophthalmology

Indianapolis, Indiana, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Cosopt and OAG progression

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Eye Pressure Lowering Surgery
NCT01931904 RECRUITING