A Safety and Efficacy Study of Bimatoprost 0.01% in Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH)

• ClinicalTrials.gov Identifier: NCT01594970
• Recruitment Status: Completed
• First Posted: May 9, 2012
• Results First Posted: January 28, 2014
• Last Update Posted: January 28, 2014
• Sponsor: Allergan
• Information provided by (Responsible Party): Allergan

Study Description

Brief Summary:

This study will evaluate the safety and efficacy of bimatoprost 0.01% in subjects with elevated intraocular pressure (IOP) due to primary open-angle glaucoma (POAG) or ocular hypertension (OH).

Condition or disease	Intervention/treatment	Phase
Glaucoma, Open-Angle; Ocular Hypertension	Drug: Bimatoprost 0.01%	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 800 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: March 2012
• Actual Primary Completion Date: January 2013
• Actual Study Completion Date: January 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Bimatoprost 0.01% (Naive Monotherapy); 1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.	Drug: Bimatoprost 0.01%; 1 drop in the affected eye(s), administered in the evening for 12 weeks.; Other Name: LUMIGAN® 0.01%
Experimental: Bimatoprost 0.01% (Switched Monotherapy); 1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.	Drug: Bimatoprost 0.01%; 1 drop in the affected eye(s), administered in the evening for 12 weeks.; Other Name: LUMIGAN® 0.01%
Experimental: Bimatoprost 0.01% (with Adjunctive Therapy); 1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.	Drug: Bimatoprost 0.01%; 1 drop in the affected eye(s), administered in the evening for 12 weeks.; Other Name: LUMIGAN® 0.01%

Outcome Measures

Primary Outcome Measures :

1. Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale [ Time Frame: Week 12 ]
   Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5 point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of participants in each severity grade are presented.

Secondary Outcome Measures :

1. Change From Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, Week 6, Week 12 ]
   IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement).
2. Overall Percent Change From Baseline in IOP [ Time Frame: Baseline, Week 6, Week 12 ]
   IOP is a measure of the fluid pressure inside the eye. A negative number change response indicates a reduction in IOP (improvement).

Other Outcome Measures:

1. Change From Baseline in Hyperemia Severity in the Study Eye [ Time Frame: Baseline, Week 12 ]
   Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia was graded in the study eye on a 5 point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). 'Lower' categories refer to grades 0, 0.5 and 1, and 'higher' categories refer to grades 2 and 3. Change in hyperemia severity was classified as improved, no change or worsened based on the change in the hyperemia grading category from higher to lower, no change in category or lower to higher, respectively. The numbers of participants in each category are presented.

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Elevated IOP due to either primary open-angle glaucoma or ocular hypertension

Exclusion Criteria:

• None

Contacts and Locations

Locations

Korea, Republic of

Seoul, Korea, Republic of

Sponsors and Collaborators

Allergan

Investigators

• Study Director: Medical Director; Allergan

More Information

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

Park KH, Simonyi S, Kim CY, Sohn YH, Kook MS. Bimatoprost 0.01% in treatment-naïve patients with open-angle glaucoma or ocular hypertension: an observational study in the Korean clinical setting. BMC Ophthalmol. 2014 Dec 17;14:160. doi: 10.1186/1471-2415-14-160.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01594970
• Other Study ID Numbers: APMA-001211
• First Posted: May 9, 2012
• Results First Posted: January 28, 2014
• Last Update Posted: January 28, 2014
• Last Verified: January 2014

Additional relevant MeSH terms:

Glaucoma; Ocular Hypertension; Glaucoma, Open-Angle; Hypertension; Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Bimatoprost; Antihypertensive Agents