Ocular Hypertension Treatment Study (OHTS) (OHTS)
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|ClinicalTrials.gov Identifier: NCT00000125|
Recruitment Status : Completed
First Posted : September 24, 1999
Results First Posted : March 19, 2015
Last Update Posted : June 2, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Ocular Hypertension Glaucoma||Drug: Topical ocular hypotensive eye drops.||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1636 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ocular Hypertension Treatment Study (OHTS)|
|Actual Study Start Date :||February 1994|
|Actual Primary Completion Date :||June 2002|
|Actual Study Completion Date :||June 30, 2019|
No Intervention: Observation
Participants treated with commercially available topical ocular hypotensive eye drops.
Drug: Topical ocular hypotensive eye drops.
Topical ocular hypotensive eye drops.
- Incidence of Primary Open-Angle Glaucoma in Hypotensive Patients [ Time Frame: 5 yrs (OHTS I, June 2002) and 13.0 yrs (completion of both phases of OHTS, March 2009) ]Comparison of the cumulative proportion of participants who develop primary open-angle glaucoma in the observation and medication groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000125
|Study Chair:||Michael A Kass, MD||Washington University Department of Ophthalmology and Visual Sciences|