Trial · NCT00000125
Ocular Hypertension Treatment Study (OHTS)
NCT00000125, Phase 3, Completed, Washington University School of Medicine; results first posted 2015-03-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ocular Hypertension Treatment Study (OHTS). Trials, record NCT00000125. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00000125
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ocular Hypertension Treatment Study (OHTS)
- NCT number
- NCT00000125
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,636 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Ocular Hypertension, Glaucoma
- Interventions
- Topical ocular hypotensive eye drops.
- First posted
- 1999-09-24
- Last updated
- 2020-06-02
- Results first posted
- 2015-03-19
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | 1636 ocular hypertensive participants were randomized to either close observation or treatment with topical hypotensive eyedrops from February 1994 through June 2002. In June 2002 the observation participants were offered treatment with topical hypotensive eyedrops. | percent of participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Primary Open-Angle Glaucoma in Hypotensive Patients | Observation | Incidence of glaucoma at 5 yr (OHTS I, June 2002) | 9.5 | percent of participants | |
| Incidence of Primary Open-Angle Glaucoma in Hypotensive Patients | Treatment | Incidence of glaucoma at 5 yr (OHTS I, June 2002) | 4.4 | percent of participants | |
| Incidence of Primary Open-Angle Glaucoma in Hypotensive Patients | Observation | Incidence of glaucoma 13 yr (OHTS II, March 2009) | 20.0 | percent of participants | |
| Incidence of Primary Open-Angle Glaucoma in Hypotensive Patients | Treatment | Incidence of glaucoma 13 yr (OHTS II, March 2009) | 14.1 | percent of participants |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Observation | 819 | |
| Overall Study | STARTED | Treatment | 817 | |
| Overall Study | Completed OHTS Phase I, June 2002 | Observation | 706 | |
| Overall Study | Completed OHTS Phase I, June 2002 | Treatment | 702 | |
| Overall Study | COMPLETED | Observation | 580 | |
| Overall Study | COMPLETED | Treatment | 579 | |
| Overall Study | NOT COMPLETED | Observation | 239 | |
| Overall Study | NOT COMPLETED | Treatment | 238 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Ocular Adverse Event (Not Serious) | Eye disorders | Observation | 481 | 819 | |
| other | Ocular Adverse Event (Not Serious) | Eye disorders | Treatment | 570 | 817 | |
| serious | Ocular Serious Adverse Events (OHTS I, June 2002) | Eye disorders | Observation | 12 | 819 | |
| serious | Ocular Serious Adverse Events (OHTS I, June 2002) | Eye disorders | Treatment | 13 | 817 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Observation | ||
| Total, all-cause mortality | Treatment | ||
| Total, other adverse events | Observation | 481 | 819 |
| Total, other adverse events | Treatment | 570 | 817 |
| Total, serious adverse events | Observation | 12 | 819 |
| Total, serious adverse events | Treatment | 13 | 817 |
Source ClinicalTrials.gov
Papers68
The papers the trial lists on ClinicalTrials.gov.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10EY009307 | Ocular hypertension treatment study (OHTS) | KASS, MICHAEL A | WASHINGTON UNIVERSITY | NATIONAL EYE INSTITUTE | 1992 to 2009 | NIH RePORTER |
| U10EY009341 | Ocular Hypertension Treatment Study: Coordinating Center | GORDON, MAE O | WASHINGTON UNIVERSITY | NATIONAL EYE INSTITUTE | 1992 to 2009 | NIH RePORTER |
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Observation vs Treatment: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00000125
GET https://conductscience.org/api/trials/v1/NCT00000125/papers?page=2