Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ocular Hypertension Treatment Study (OHTS) (OHTS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00000125
Recruitment Status : Active, not recruiting
First Posted : September 24, 1999
Results First Posted : March 19, 2015
Last Update Posted : June 6, 2018
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Michael Kass, Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE September 23, 1999
First Posted Date  ICMJE September 24, 1999
Results First Submitted Date March 6, 2015
Results First Posted Date March 19, 2015
Last Update Posted Date June 6, 2018
Study Start Date  ICMJE February 1994
Actual Primary Completion Date June 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2015)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00000125 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Ocular Hypertension Treatment Study (OHTS)
Official Title  ICMJE Ocular Hypertension Treatment Study (OHTS)
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.

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.

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 because 20 years approaches the median life expectancy of OHT patients in their 60's and 70's and half the median life expectancy of patients in their 40's and 50's. For the first time, patients with ocular hypertension and clinicians will have high quality data about the long-term risk of developing POAG and functional limitations associated with the disease. These data will facilitate patient-centered care so that patients and clinicians can decide on the appropriate frequency of tests and examinations and the potential benefit of preventative treatment.

Glaucoma is one of the leading causes of blindness in the United States and other industrialized countries. It is estimated that 2 million people in the United States have glaucoma and that 80,000 of these individuals are legally blind from the disease. Among African Americans, glaucoma is now recognized as the leading cause of blindness.

Elevated intraocular pressure (IOP), a common condition affecting 3 to 6 million people in the United States, is thought to be the leading risk factor for development of open-angle glaucoma. There is no consensus that medical reduction of intraocular pressure prevents or delays the onset of visual field and/or optic nerve damage in ocular hypertensive subjects.

Despite the lack of convincing evidence for the efficacy of medical treatment in ocular hypertension, approximately 1.5 million glaucoma suspects in the United States are being treated with costly ocular hypotensive medications that carry the potential for serious and even life-threatening side effects.

Clearly, there is a need for a well-controlled clinical trial to determine whether medical reduction of IOP can prevent or delay the onset of glaucomatous damage in ocular hypertensive subjects. Only then can clinicians and patients make rational choices and health care planners ensure that limited medical resources are being allocated in a safe and cost-effective manner.

The Ocular Hypertension Treatment Study (OHTS) is a long-term, randomized, controlled multicenter clinical trial. Ocular hypertensive subjects judged to be at moderate risk of developing primary open-angle glaucoma are randomly assigned to either close observation only or a stepped medical regimen. Medical treatment consists of all commercially available topical ocular hypotensive eye drops.

After completion of baseline measures (IOP, visual fields, disc photos) and randomization, the subjects are followed for a minimum of 5 years with automated threshold central static perimetry (Humphrey program 30-2) twice yearly and stereoscopic optic disc photographs once yearly. Study end points are reproducible visual field loss and/or progressive optic disc damage in either eye of a patient attributed to glaucoma by a Masked Endpoint Committee. All visual fields and optic disc photographs are read in a masked fashion in Reading Centers.

In the 1991 Baltimore Eye Survey, African Americans were shown to have a prevalence of open-angle glaucoma four to five times higher than whites. Given this high prevalence of glaucoma in the African American population, it is important to recruit and follow an adequate sample of African American subjects in the trial (approximately 25 percent of the total patient sample).

At the conclusion of this study, practitioners should be able to make reasonable estimates of risk for individual ocular hypertensive patients and to determine which ocular hypertensive individuals are most likely to benefit from early prophylactic medical treatment.

Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Ocular Hypertension
  • Glaucoma
Intervention  ICMJE Drug: Topical ocular hypotensive eye drops.
Topical ocular hypotensive eye drops.
Study Arms
  • No Intervention: Observation
    Close Observation.
  • Treatment
    Participants treated with commercially available topical ocular hypotensive eye drops.
    Intervention: Drug: Topical ocular hypotensive eye drops.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 2, 2011)
1636
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date March 2020
Actual Primary Completion Date June 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00000125
Other Study ID Numbers  ICMJE NEI-24
5U10EY009307-16 ( U.S. NIH Grant/Contract )
5U10EY009341-14 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Michael Kass, Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE National Eye Institute (NEI)
Investigators  ICMJE
Study Chair: Michael A Kass, MD Washington University Department of Ophthalmology and Visual Sciences
PRS Account Washington University School of Medicine
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP