A Study of 0.03% Bimatoprost in the Treatment of Primary Open Angle Glaucoma and Ocular Hypertension (LOTUSDI)
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ClinicalTrials.gov Identifier: NCT02020512 |
Recruitment Status :
Completed
First Posted : December 25, 2013
Results First Posted : July 21, 2014
Last Update Posted : July 21, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Glaucoma, Open-Angle Ocular Hypertension | Drug: 0.03% Bimatoprost | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 87 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | July 2011 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | December 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: 0.03% Bimatoprost
0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
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Drug: 0.03% Bimatoprost
0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
Other Name: LUMIGAN® |
- Change From Baseline in Intraocular Pressure (IOP) in the Study Eye [ Time Frame: Baseline, Week 5 ]IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of open-angle glaucoma or ocular hypertension
- No use of Lumigan® in the past 3 months
Exclusion Criteria:
- Received laser therapy, glaucoma surgery, cataract surgery, or other ocular surgery within the past 3 months

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): NCT02020512
China | |
Guangzhou, China |
Study Director: | Medical Director | Allergan |
Responsible Party: | Allergan |
ClinicalTrials.gov Identifier: | NCT02020512 |
Other Study ID Numbers: |
CN-BIM-1102 |
First Posted: | December 25, 2013 Key Record Dates |
Results First Posted: | July 21, 2014 |
Last Update Posted: | July 21, 2014 |
Last Verified: | June 2014 |
Glaucoma Ocular Hypertension Glaucoma, Open-Angle Hypertension Vascular Diseases |
Cardiovascular Diseases Eye Diseases Bimatoprost Antihypertensive Agents |