Phase 3
N=1,636
Ocular Hypertension Treatment Study (OHTS)
Ocular Hypertension · Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT00000125 ↗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
| Outcome | Result | p-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.
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.