Glaucoma Biomarkers
Condition: Glaucoma; Healthy
MeSH terms: Glaucoma
Intervention: Variation in eye pressure response to timolol and latanoprost treatment
Intervention description: 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 MeSH terms: Timolol; Latanoprost
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 135.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: glaucoma; aqueous humor dynamics; intraocular pressure

Summary:

      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.
    

Eligibility criteria:

        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.

          -  Nonprescription and prescription topical ophthalmic products and systemic medications
             other than those mentioned in the exclusion criteria will be allowed during the study.

          -  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.

        Exclusion Criteria:

          -  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.