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This study will evaluate the 24-hour IOP-lowering efficacy of 0.01% bimatoprost once daily in patients with glaucoma or ocular hypertension
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.01% bimatoprost | Experimental | bimatoprost 0.01% one time per day at bedtime for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.01% bimatoprost | Drug | 0.01% bimatoprost once in the evening for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nocturnal Intraocular Pressure (IOP) Change | Nocturnal IOP means under bimatoprost 0.01% treatment were compared with baseline. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Liu, PhD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Shiley Eye Center | La Jolla | California | 92093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22918671 | Result | Tung JD, Tafreshi A, Weinreb RN, Slight JR, Medeiros FA, Liu JH. Twenty-four-hour effects of bimatoprost 0.01% monotherapy on intraocular pressure and ocular perfusion pressure. BMJ Open. 2012 Aug 23;2(4):e001106. doi: 10.1136/bmjopen-2012-001106. Print 2012. |
| Label | URL |
|---|---|
| Open access publication | View source |
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Subjects who smoked, had previous glaucoma surgery in either eye, had a history of ocular trauma or a sleep disorder, or had an irregular sleep schedule were excluded.
Experimental subjects were recruited consecutively from patients with diagnosed bilateral primary open angle glaucoma or ocular hypertension at the Hamilton Glaucoma Center of the University of California, San Diego.
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.01% Bimatoprost | 0.01% bimatoprost: 0.01% bimatoprost eye drop once in the evening both eyes for 4 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.01% Bimatoprost | 0.01% bimatoprost: 0.01% bimatoprost once in the evening for 4 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Nocturnal Intraocular Pressure (IOP) Change | Nocturnal IOP means under bimatoprost 0.01% treatment were compared with baseline. | Posted | Mean | Standard Deviation | mmHg | 4 weeks |
|
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.01% Bimatoprost | 0.01% bimatoprost: 0.01% bimatoprost eye drop once in the evening both eyes for 4 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Liu | University of California, San Diego | 858 534-7056 | joliu@ucsd.edu |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069580 | Bimatoprost |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 16 |
| 0 |
| 16 |
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| D011465 |
| Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |