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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 : Completed
First Posted : September 24, 1999
Results First Posted : March 19, 2015
Last Update Posted : June 2, 2020
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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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.


Condition or disease Intervention/treatment Phase
Ocular Hypertension Glaucoma Drug: Topical ocular hypotensive eye drops. Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1636 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Observation
Close Observation.
Treatment
Participants treated with commercially available topical ocular hypotensive eye drops.
 Drug: Topical ocular hypotensive eye drops.
Topical ocular hypotensive eye drops.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Sponsors and Collaborators
Washington University School of Medicine
National Eye Institute (NEI)
Investigators
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Study Chair: Michael A Kass, MD Washington University Department of Ophthalmology and Visual Sciences
  Study Documents (Full-Text)

Documents provided by Washington University School of Medicine:
Informed Consent Form  [PDF] February 6, 2019

More Information
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Publications:
Bailey JN, Loomis SJ, Kang JH, Allingham RR, Gharahkhani P, Khor CC, Burdon KP, Aschard H, Chasman DI, Igo RP Jr, Hysi PG, Glastonbury CA, Ashley-Koch A, Brilliant M, Brown AA, Budenz DL, Buil A, Cheng CY, Choi H, Christen WG, Curhan G, De Vivo I, Fingert JH, Foster PJ, Fuchs C, Gaasterland D, Gaasterland T, Hewitt AW, Hu F, Hunter DJ, Khawaja AP, Lee RK, Li Z, Lichter PR, Mackey DA, McGuffin P, Mitchell P, Moroi SE, Perera SA, Pepper KW, Qi Q, Realini T, Richards JE, Ridker PM, Rimm E, Ritch R, Ritchie M, Schuman JS, Scott WK, Singh K, Sit AJ, Song YE, Tamimi RM, Topouzis F, Viswanathan AC, Verma SS, Vollrath D, Wang JJ, Weisschuh N, Wissinger B, Wollstein G, Wong TY, Yaspan BL, Zack DJ, Zhang K, Study EN; ANZRAG Consortium, Weinreb RN, Pericak-Vance MA, Small K, Hammond CJ, Aung T, Liu Y, Vithana EN, MacGregor S, Craig JE, Kraft P, Howell G, Hauser MA, Pasquale LR, Haines JL, Wiggs JL. Genome-wide association analysis identifies TXNRD2, ATXN2 and FOXC1 as susceptibility loci for primary open-angle glaucoma. Nat Genet. 2016 Feb;48(2):189-94. doi: 10.1038/ng.3482. Epub 2016 Jan 11.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00000125    
Other Study ID Numbers: NEI-24
5U10EY009307-16 ( U.S. NIH Grant/Contract )
5U10EY009341-14 ( U.S. NIH Grant/Contract )
First Posted: September 24, 1999    Key Record Dates
Results First Posted: March 19, 2015
Last Update Posted: June 2, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
 Eye Diseases
Antihypertensive Agents
Ophthalmic Solutions
Pharmaceutical Solutions