Trial Outcomes & Findings for An Open-label Extension Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert (NCT NCT02537015)
NCT ID: NCT02537015
Last Updated: 2019-04-02
Results Overview
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.
COMPLETED
PHASE2
81 participants
Baseline (Day 0, enrollment in this study) to end of study (Week 38)
2019-04-02
Participant Flow
Participants who completed the Phase 2 study FSV5-004 \[NCT02358369\] were eligible to enroll in this open-label extension study.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
81
|
|
Overall Study
COMPLETED
|
75
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Other Miscellaneous Reasons
|
1
|
Baseline Characteristics
An Open-label Extension Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert
Baseline characteristics by cohort
| Measure |
13 mg Bimatoprost Ocular Insert
n=81 Participants
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.
|
|---|---|
|
Age, Continuous
|
64.8 years
STANDARD_DEVIATION 9.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0, enrollment in this study) to end of study (Week 38)Population: Safety Population included all enrolled participants who had at least one 13 mg Bimatoprost Ocular Insert placed.
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.
Outcome measures
| Measure |
13 mg Bimatoprost Ocular Insert
n=81 Participants
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.
|
|---|---|
|
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity
Ocular, Mild
|
25.9 percentage of participants
|
|
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity
Ocular, Moderate
|
11.1 percentage of participants
|
|
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity
Ocular, Severe
|
0 percentage of participants
|
|
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity
Non-Ocular, Mild
|
6.2 percentage of participants
|
|
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity
Non-Ocular, Moderate
|
8.6 percentage of participants
|
|
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity
Non-Ocular, Severe
|
4.9 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 0 in study FSV5-004) to Weeks 4, 8, 12, 24 and 38Population: Per Protocol, this Outcome Measure previously registered on ClinicalTrials.gov as a Secondary Outcome Measure is an Other Pre-specified Outcome Measure.
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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 0, enrollment in this study) Weeks 4, 8, 12, 24 and 38The 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
Adverse Events
13 mg Bimatoprost Ocular Insert
Serious adverse events
| Measure |
13 mg Bimatoprost Ocular Insert
n=81 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
1/81 • Baseline (Day 0-enrollment in this study) to the end of study (Week 38)
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.2%
1/81 • Baseline (Day 0-enrollment in this study) to the end of study (Week 38)
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.2%
1/81 • Baseline (Day 0-enrollment in this study) to the end of study (Week 38)
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
1.2%
1/81 • Baseline (Day 0-enrollment in this study) to the end of study (Week 38)
|
|
Metabolism and nutrition disorders
Fluid overload
|
1.2%
1/81 • Baseline (Day 0-enrollment in this study) to the end of study (Week 38)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.2%
1/81 • Baseline (Day 0-enrollment in this study) to the end of study (Week 38)
|
|
Vascular disorders
Hypertension
|
1.2%
1/81 • Baseline (Day 0-enrollment in this study) to the end of study (Week 38)
|
Other adverse events
| Measure |
13 mg Bimatoprost Ocular Insert
n=81 participants at risk
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.
|
|---|---|
|
Eye disorders
Punctate keratitis
|
12.3%
10/81 • Baseline (Day 0-enrollment in this study) to the end of study (Week 38)
|
|
Eye disorders
Eye discharge
|
11.1%
9/81 • Baseline (Day 0-enrollment in this study) to the end of study (Week 38)
|
|
Eye disorders
Ocular discomfort
|
6.2%
5/81 • Baseline (Day 0-enrollment in this study) to the end of study (Week 38)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No presentation or publication of Institution's data relating to the Trial may occur until after the Trial has been completed at all sites. If Investigator desires to present or publish, investigator must submit any and all manuscripts, posters, abstracts, or other intended publications (hereinafter collectively referred to as "manuscripts") to Sponsor at least sixty (60) days prior to the actual submission of such manuscript(s) for publication.
- Publication restrictions are in place
Restriction type: OTHER