Mode
Text Size
Log in / Sign up
Phase 3 N=1,636 Randomized Prevention

Ocular Hypertension Treatment Study (OHTS)

Ocular Hypertension · Glaucoma

Enrolled (actual)
1,636
Serious AEs
1.5%
Results posted
Mar 2015
Primary outcome: Primary: Incidence of Primary Open-Angle Glaucoma in Hypotensive Patients — 9.5; 4.4; 20.0; 14.1 percent of participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Topical ocular hypotensive eye drops. (Drug)
Age
Adult, Older Adult · 40+ yrs
Sex
All
Sponsor
Washington University School of Medicine
Primary completion
Jun 2002

Outcome Measures

OutcomeResultp-value
PRIMARY
Incidence of Primary Open-Angle Glaucoma in Hypotensive Patients
9.5; 4.4; 20.0; 14.1

Summary

To determine whether medical reduction of intraocular pressure prevents or delays the onset of glaucomatous visual field loss and/or optic disc damage in ocular hypertensive participants judged to be at moderate risk for developing open-angle glaucoma. To produce natural history data to assist in identifying patients at most risk for developing open-angle glaucoma and those most likely to benefit from early medical treatment. To quantify risk factors for developing open-angle glaucoma among ocular hypertensive individuals.

Eligibility Criteria

Men and nonpregnant women between the ages of 40 and 80 with IOP greater than or equal to 24 mm Hg but less than or equal to 32 mm Hg in at least one eye and IOP greater than or equal to 21 but less than or equal to 32 mm Hg in the fellow eye, as well as normal visual fields and optic discs are eligible for the trial. Patients presenting with best-corrected visual acuity worse than 20/40 in either eye, previous intraocular surgery, a life-threatening or debilitating disease, secondary causes of elevated IOP, angle-closure glaucoma or anatomically narrow angles, other diseases that can cause visual field loss, background diabetic retinopathy, optic disc abnormalities that can produce visual field loss or obscure the interpretation of the optic disc, or unwillingness to undergo random assignment are excluded from the trial.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00000125). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search