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24-hour IOP-lowering Effect of 0.01% Bimatoprost

University of California San Diego logo

University of California San Diego

Status and phase

Completed
Phase 4

Conditions

Glaucoma
Ocular Hypertension
Intraocular Pressure

Treatments

Drug: 0.01% bimatoprost

Study type

Interventional

Funder types

Other

Identifiers

NCT01271686
UCSD 101705 bimatoprost

Details and patient eligibility

About

This study will evaluate the 24-hour IOP-lowering efficacy of 0.01% bimatoprost once daily in patients with glaucoma or ocular hypertension

Full description

Objectives To investigate the 24 h effects of bimatoprost 0.01% monotherapy on intraocular pressure (IOP) and ocular perfusion pressure (OPP).

Design Prospective, open-label experimental study.

Setting Single tertiary ophthalmic clinic.

Participants Sixteen patients with diagnosed primary open-angle glaucoma (POAG) or ocular hypertension (ages, 49-77 years).

Interventions Baseline data of 24 h IOP in untreated patients were collected in a sleep laboratory. Measurements of IOP were taken using a pneumatonometer every 2 h in the sitting and supine body positions during the 16 h diurnal/wake period and in the supine position during the 8 h nocturnal/sleep period. After baseline measurements were taken, patients were treated with bimatoprost 0.01% one time per day at bedtime for 4 weeks, and then 24 h IOP data were collected under the same laboratory conditions.

Primary outcome measure of nocturnal IOP mean under bimatoprost 0.01% treatment was compared with baseline.

Enrollment

16 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • primary open-angle glaucoma or ocular hypertension

Exclusion criteria

  • Women of childbearing potential previous glaucoma surgery presence of other eye disease

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

16 participants in 1 patient group

0.01% bimatoprost
Experimental group
Description:
bimatoprost 0.01% one time per day at bedtime for 4 weeks.
Treatment:
Drug: 0.01% bimatoprost

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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