Glaucoma Biomarkers

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

Clinical Phase

PHASE4

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2016-08-30

Brief Summary

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

Glaucoma is a major cause of blindness. The inability to predict a patient's IOP response to medications is a critical barrier for the clinician to consistently provide highly effective IOP-based treatments. Current trial-and error approaches to glaucoma management are inefficient and have not addressed this barrier as there are no predictive factors for drug response. Our long-term goal is to improve outcomes by identifying biomarkers and environmental factors that profile a patient at risk for glaucoma by age-of-onset, rate of disease progression, "poor response" to treatment, and large IOP fluctuation. Our purpose of this research project is to address this critical barrier by focusing on physiological factors that predict IOP response to drugs.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Aqueous Humor Dynamic Components That Determine Intraocular Pressure Variance

NCT04412096

Glaucoma OHT - Ocular Hypertension

COMPLETED PHASE4

Comparison of Latanoprost Vs. Timolol

NCT00579969

Glaucoma

TERMINATED PHASE2

Study of Corneal Biomechanics in Glaucoma Patients Using Brillouin Microscopy

NCT06993597

Glaucoma

RECRUITING

A Study of Glaucoma or Ocular Hypertension in Patients Within the United States

NCT00800267

Ocular Hypertension Glaucoma

COMPLETED PHASE3

Safety and Efficacy Study of Bimatoprost, Latanoprost, and Travoprost in Patients With Elevated Intraocular Pressure (IOP) and Open-angle Glaucoma (OAG)

NCT00716742

Open-Angle Glaucoma Ocular Hypertension

COMPLETED

Detailed Description

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

Conditions

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

Glaucoma Healthy

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

timolol

To compare the variation in response to timolol between individuals

Group Type EXPERIMENTAL

Variation in eye pressure response to timolol and latanoprost treatment

Intervention Type DRUG

Arm 1 is to test for variation in eye pressure response to timolol. Arm 2 is to test for variation in eye pressure response to latanoprost.

latanoprost

To compare the variation in response to latanoprost between individuals

Group Type ACTIVE_COMPARATOR

Variation in eye pressure response to timolol and latanoprost treatment

Intervention Type DRUG

Arm 1 is to test for variation in eye pressure response to timolol. Arm 2 is to test for variation in eye pressure response to latanoprost.

Interventions

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

Variation in eye pressure response to timolol and latanoprost treatment

Arm 1 is to test for variation in eye pressure response to timolol. Arm 2 is to test for variation in eye pressure response to latanoprost.

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* Either gender.
* Any self-declared ethnoracial category.
* Greater than or equal to 40 years.
* Healthy eyes with the crystalline lens, without glaucoma (cup:disc ratio \< 0.8 both eyes; asymmetry of cup:disc ratio between eyes \< 0.2).
* Open angles.
* Ability to cooperate for aqueous humor dynamic studies.

Exclusion Criteria

* Contact lenses removed prior to topical fluorescein instillation, and not used until the end of each fluorophotometry session.
* Able to participate on site over the multi-visit study period.

* Women who are pregnant due to IOP changes.
* Any form of glaucoma, including extremely narrow angle with complete or partial closure.
* Current use of any glaucoma medication, either topically or orally.
* Chronic or recurrent inflammatory eye disease.
* Ocular trauma within the past 6 months.
* Ocular infection or ocular inflammation in the past 3 months.
* Clinically significant retinal disease.
* Any abnormality preventing reliable fluorophotometry of either eye, such as corneal scarring or severe dry eye that results in punctate fluorescein staining of the cornea.
* Intraocular surgery within 6 months.
* Serious hypersensitivity to any components of the study medications or risk from treatment with glaucoma medications, such as severe asthma or emphysema.
* Subjects must be on a stable regimen for at least 30 days prior to the Visit 1 regarding a chronic systemic medication that may affect IOP (i.e., sympathomimetic agents, beta-blockers, alpha-adrenergic agonists, alpha-adrenergic blockers, calcium channel blockers, angiotensin converting enzyme inhibitors, etc.). Any change of such medication during the study period will result in exclusion.
* Use of any glucocorticoid by any route. Subject must be washed out of the glucocorticoid for at least 2 weeks before study entry.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes