Trial Outcomes & Findings for Ocular Hypertension Treatment Study (OHTS) (NCT NCT00000125)
NCT ID: NCT00000125
Last Updated: 2020-06-02
Results Overview
Comparison of the cumulative proportion of participants who develop primary open-angle glaucoma in the observation and medication groups.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1636 participants
Primary outcome timeframe
5 yrs (OHTS I, June 2002) and 13.0 yrs (completion of both phases of OHTS, March 2009)
Results posted on
2020-06-02
Participant Flow
Participant milestones
| Measure |
Observation
Close Observation
|
Treatment
Topical ocular hypotensive eye drops.
|
|---|---|---|
|
Overall Study
STARTED
|
819
|
817
|
|
Overall Study
Completed OHTS Phase I, June 2002
|
706
|
702
|
|
Overall Study
COMPLETED
|
580
|
579
|
|
Overall Study
NOT COMPLETED
|
239
|
238
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ocular Hypertension Treatment Study (OHTS)
Baseline characteristics by cohort
| Measure |
Observation
n=819 Participants
Observation only
|
Treatment
n=817 Participants
Topical Antiglaucoma Agents: Topical Antiglaucoma Agents
|
Total
n=1636 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.6 years
STANDARD_DEVIATION 9.7 • n=93 Participants
|
55.2 years
STANDARD_DEVIATION 9.5 • n=4 Participants
|
55.4 years
STANDARD_DEVIATION 9.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
346 Participants
n=93 Participants
|
359 Participants
n=4 Participants
|
705 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
473 Participants
n=93 Participants
|
458 Participants
n=4 Participants
|
931 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Native American
|
3 participants
n=93 Participants
|
1 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
10 participants
n=93 Participants
|
4 participants
n=4 Participants
|
14 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
African American
|
205 participants
n=93 Participants
|
203 participants
n=4 Participants
|
408 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
35 participants
n=93 Participants
|
24 participants
n=4 Participants
|
59 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
560 participants
n=93 Participants
|
577 participants
n=4 Participants
|
1137 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 participants
n=93 Participants
|
8 participants
n=4 Participants
|
14 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 5 yrs (OHTS I, June 2002) and 13.0 yrs (completion of both phases of OHTS, March 2009)Population: 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.
Comparison of the cumulative proportion of participants who develop primary open-angle glaucoma in the observation and medication groups.
Outcome measures
| Measure |
Observation
n=819 Participants
Observation only from February 1994 through June 2002.Observation participants were offered topical antiglaucoma agents after June 2002 through study close out March 2009.
|
Treatment
n=817 Participants
Topical ocular hypotensive eye drops from February 1994 through March 2009.
|
|---|---|---|
|
Incidence of Primary Open-Angle Glaucoma in Hypotensive Patients
Incidence of glaucoma at 5 yr (OHTS I, June 2002)
|
9.5 percent of participants
|
4.4 percent of participants
|
|
Incidence of Primary Open-Angle Glaucoma in Hypotensive Patients
Incidence of glaucoma 13 yr (OHTS II, March 2009)
|
20.0 percent of participants
|
14.1 percent of participants
|
Adverse Events
Observation
Serious events: 12 serious events
Other events: 481 other events
Deaths: 0 deaths
Treatment
Serious events: 13 serious events
Other events: 570 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Observation
n=819 participants at risk
Observation only from February 1994 to June 2002 .
|
Treatment
n=817 participants at risk
Topical Antiglaucoma Agents: Topical Antiglaucoma Agents from February 1994 to June 2002.
|
|---|---|---|
|
Eye disorders
Ocular Serious Adverse Events (OHTS I, June 2002)
|
1.5%
12/819 • Adverse events collected during OHTS I, from February 1994 to June 2002.
Specific ocular adverse events are unknown because adverse events were only collected with regard to organ system.
|
1.6%
13/817 • Adverse events collected during OHTS I, from February 1994 to June 2002.
Specific ocular adverse events are unknown because adverse events were only collected with regard to organ system.
|
Other adverse events
| Measure |
Observation
n=819 participants at risk
Observation only from February 1994 to June 2002 .
|
Treatment
n=817 participants at risk
Topical Antiglaucoma Agents: Topical Antiglaucoma Agents from February 1994 to June 2002.
|
|---|---|---|
|
Eye disorders
Ocular Adverse Event (Not Serious)
|
58.7%
481/819 • Adverse events collected during OHTS I, from February 1994 to June 2002.
Specific ocular adverse events are unknown because adverse events were only collected with regard to organ system.
|
69.8%
570/817 • Adverse events collected during OHTS I, from February 1994 to June 2002.
Specific ocular adverse events are unknown because adverse events were only collected with regard to organ system.
|
Additional Information
Michael Kass MD
Washington University School of Medicine
Phone: 314-362-5713
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place