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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00803998
Other study ID # 93.01
Secondary ID
Status Completed
Phase N/A
First received December 5, 2008
Last updated October 31, 2013
Start date February 1994
Est. completion date December 2006

Study information

Verified date December 2008
Source The New York Eye & Ear Infirmary
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The Ocular Hypertension Treatment Study is a multi-center clinical trial sponsored by the National Eye Institute, designed to determine the efficacy and safety of topically administered eye lowering medication


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria:

- Qualifying IOP in at least one eye of each participant must be more than or equal 24 mmHg but less than or equal to 32 mm HG calculated from two separate consecutive determination taken at least 2 hours, but not greater than 12 weeks apart.

- Normal and reliable 30-2 Humphrey Visual Fields in both eyes.

- Normal Optic disc in both eyes on clinical examinations and stereoscopic photographs as determined by the Optic Disc Reading Center.

Exclusion Criteria:

- Visual acuity worse than 20/40 in either eye on qualifying exam.

- Previous intraocular surgery: laser trabeculoplasty, laser iridotomy, filtering surgery, combined cataract extraction/filtering procedures, penetrating keratoplasty and retinal detachment repair.

Study Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
The New York Eye & Ear Infirmary National Eye Institute (NEI)

References & Publications (1)

Gordon MO, Beiser JA, Brandt JD, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish RK 2nd, Wilson MR, Kass MA. The Ocular Hypertension Treatment Study: baseline factors that predict the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002 Jun;120(6):714-20; discussion 829-30. — View Citation

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