Ocular Hypertension Treatment Study (OHTS)

Phase 3

Completed

• Conditions: Ocular Hypertension; Glaucoma
• Interventions: Drug: Topical ocular hypotensive eye drops.

• Registration Number: NCT00000125
• Lead Sponsor: Washington University School of Medicine

Brief 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.
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Detailed Description

OHTS Phase 3 will re-examine study participants 20 plus years after enrollment to document clinical status and the incidence and severity of self-reported functional limitations. The 279 participants who developed POAG in OHTS Phase 1 or 2 will have more than 10 years of post-POAG follow-up by Phase 3. The timing of re-examination at 20 years is meaningful b...

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 1994-02
• Study First Submitted: 1999-09-23
• Study First Submitted QC: 1999-09-23
• Study First Posted: 1999-09-24
• Primary Completion: 2002-06
• Results First Submitted: 2015-03-06
• Results First Submitted QC: 2015-03-06
• Results First Posted: 2015-03-19
• Study Completion: 2019-06-30
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-20
• Last Update Posted: 2020-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1636

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Topical ocular hypotensive eye drops.	Participants treated with commercially available topical ocular hypotensive eye drops.

Primary Outcome Measures

Name	Time	Method
Incidence of Primary Open-Angle Glaucoma in Hypotensive Patients	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.