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Diurnal and Nocturnal Effect of Travatan With SofZia Preservative on Intraocular Pressure and Ocular Perfusion Pressure

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Completed

Conditions

Open Angle Glaucoma
Ocular Hypertension

Study type

Observational

Funder types

Other

Identifiers

NCT01779778
12-0175

Details and patient eligibility

About

The purpose of this research study is to determine the diurnal and nocturnal effects of Travoprost with SofZia (Travatan Z) on intraocular pressure and ocular perfusion pressure.

Full description

The investigators hypothesize that Travatan Z will significantly lower intraocular pressure and increase ocular perfusion pressure during both the diurnal and nocturnal period, during a 24-hour evaluation, compared to baseline. The investigators further hypothesize that the medication effects will persist at 72 hours after discontinuation of the drug.

Enrollment

40 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of open-angle glaucoma or ocular hypertension, including pigment dispersion glaucoma and pseudoexfoliation glaucoma
  • Age ≥ 18 or ≤ 90 years, of either gender, or any race/ethnicity

Exclusion criteria

  • Females who are currently pregnant or planning to become pregnant, as determined by history during the study period
  • Diagnosis of any other form of glaucoma other than open-angle
  • Schaffer angle grade < 2 in either eye by gonioscopy
  • Chronic, recurrent, or severe inflammatory eye disease
  • Intraocular surgery within 6 months or laser within 3 months
  • History of active, recurrent, or chronic ocular infection with the Herpes Simplex Virus
  • History of cystoid macular edema
  • Inability to safely discontinue all ocular medications for 4 weeks
  • Patients who smoke or have irregular daily sleep patterns
  • Patients who have started or changed glucocorticoids therapy in the last 3 months
  • Patients who are currently undergoing medical marijuana therapy
  • Any use of a non-FDA approved medication for glaucoma in the last 3 months

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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