An Open-label Extension Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert (OLE2)
|ClinicalTrials.gov Identifier: NCT02537015|
Recruitment Status : Completed
First Posted : September 1, 2015
Results First Posted : February 26, 2019
Last Update Posted : April 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Primary Open-Angle Glaucoma Ocular Hypertension||Drug: Bimatoprost||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Extension (OLE 2) Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert in Subjects With Open-angle Glaucoma or Ocular Hypertension Who Have Completed Study FSV5-004|
|Actual Study Start Date :||August 10, 2015|
|Actual Primary Completion Date :||August 11, 2016|
|Actual Study Completion Date :||August 11, 2016|
Experimental: 13 mg Bimatoprost Ocular Insert
13 mg Bimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new 13 mg Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks.
Bimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks.
Other Name: "Lumigan" is the branded name of bimatoprost in eye drop form
- Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity [ Time Frame: Baseline (Day 0, enrollment in this study) to end of study (Week 38) ]An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study. An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye. The investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity.
- Change From Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline (Day 0 in study FSV5-004) to Weeks 4, 8, 12, 24 and 38 ]IOP is a measurement of the fluid pressure inside the eye. IOP measurements were taken at 8 am (Time (T)=0 hour) at Weeks 4, 8, 12, 24 and 38. Diurnal IOP measurements were also taken at 10 am (T=2 hour), and 4 pm (T=8 hour) at Weeks 12, 24 and 38. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement. Baseline is defined as the IOP assessment done at the Randomization visit (Day 0) of study FSV5-004.
- Percentage of Participants by Subject-Reported Comfort Assessment Categories [ Time Frame: Baseline (Day 0, enrollment in this study) Weeks 4, 8, 12, 24 and 38 ]The participant assessed their overall comfort with ocular inserts using the following rating choices: Not aware of inserts, very comfortable; Aware of inserts, and comfortable; Tolerable, but mild discomfort; Moderate discomfort or Severe discomfort. The percentage of participants in each rating category is reported.
- Bimatoprost Ocular Insert Retention Duration [ Time Frame: Baseline (Day 0, enrollment in this study) to the end of study (Week 38) ]Insert duration was defined as the total duration (in days) that any ocular insert remained in place for each subject, measured from the date of Insert removal minus date of Insert placement + 1.
- Percentage of Participants Who Received Rescue Treatment [ Time Frame: Baseline (Day 0, enrollment in this study) to the end of study (Week 38) ]Rescue treatment with topical bimatoprost was available for each eye if deemed necessary by the investigator to achieve desired IOP.
- Change From Baseline in Endothelial Cell Count [ Time Frame: Baseline (Day 0, enrollment in this study) to end of study (Week 38) ]Density (number of cells/mm^2) of corneal endothelial cells was determined at four sites using specular microscopy of the central corneal endothelium at Baseline and at Week 38.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537015
|United States, Arkansas|
|Fayetteville, Arkansas, United States, 72704|
|United States, California|
|Sall Medical Research Center|
|Artesia, California, United States, 90701|
|Eye Research Foundation|
|Newport Beach, California, United States, 92663|
|United States, Georgia|
|Clayton Eye Center|
|Morrow, Georgia, United States, 30260|
|United States, North Carolina|
|Mundorf Eye Center|
|Charlotte, North Carolina, United States, 28204|
|Cornerstone Health Care; Cornerstone Eye Care|
|High Point, North Carolina, United States, 27262|
|United States, Tennessee|
|University Eye Specialists|
|Maryville, Tennessee, United States, 37803|
|Total Eye Care|
|Memphis, Tennessee, United States, 38119|
|United States, Texas|
|R&R Eye Research, LLC|
|San Antonio, Texas, United States, 78229|
|Study Director:||Michelle Chen, PhD||Allergan|