Trial Outcomes & Findings for Safety and Efficacy of a Drug Delivery System in Glaucoma (NCT NCT01016691)
NCT ID: NCT01016691
Last Updated: 2015-03-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
Baseline to Day 1
Results posted on
2015-03-06
Participant Flow
Participant milestones
| Measure |
High Dose Drug Device/ Bimatoprost 0.03%
high dose drug device during first period, bimatoprost 0.03% during second period.
|
Low Dose Drug Device / Bimatoprost 0.03%
low-dose drug device during first period, bimatoprost 0.03% during second period.
|
Placebo Device / Bimatoprost 0.03%
placebo device during first period, bimatoprost 0.03% during second period.
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
12
|
18
|
|
Overall Study
COMPLETED
|
17
|
12
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of a Drug Delivery System in Glaucoma
Baseline characteristics by cohort
| Measure |
High Dose Drug Device/ Bimatoprost 0.03%
n=17 Participants
high dose drug device during first period, bimatoprost 0.03% during second period.
|
Low Dose Drug Device / Bimatoprost 0.03%
n=12 Participants
low-dose drug device during first period, bimatoprost 0.03% during second period.
|
Placebo Device / Bimatoprost 0.03%
n=18 Participants
placebo device during first period, bimatoprost 0.03% during second period.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.8 years
STANDARD_DEVIATION 9.78 • n=5 Participants
|
66.3 years
STANDARD_DEVIATION 11.37 • n=7 Participants
|
63.1 years
STANDARD_DEVIATION 9.07 • n=5 Participants
|
63.4 years
STANDARD_DEVIATION 8.68 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
12 participants
n=7 Participants
|
18 participants
n=5 Participants
|
47 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 1Population: per-protocol population
Outcome measures
| Measure |
High Dose Drug Device/ Bimatoprost 0.03%
n=14 Participants
high dose drug device during first period, bimatoprost 0.03% during second period.
|
Low Dose Drug Device / Bimatoprost 0.03%
n=11 Participants
low-dose drug device during first period, bimatoprost 0.03% during second period.
|
Placebo Device / Bimatoprost 0.03%
n=15 Participants
placebo device during first period, bimatoprost 0.03% during second period.
|
|---|---|---|---|
|
Mean Change in Intraocular Pressure at Day 1
|
-4.16 mmHg
Standard Deviation 3.409
|
-4.57 mmHg
Standard Deviation 3.645
|
-0.60 mmHg
Standard Deviation 2.331
|
SECONDARY outcome
Timeframe: Baseline to Day 2Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Day 3Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Day 4Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 4 to Day 5Outcome measures
Outcome data not reported
Adverse Events
High Dose Drug Device/ Bimatoprost 0.03%
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Low Dose Drug Device / Bimatoprost 0.03%
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo Device / Bimatoprost 0.03%
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High Dose Drug Device/ Bimatoprost 0.03%
n=17 participants at risk
high dose drug device during first period, bimatoprost 0.03% during second period.
|
Low Dose Drug Device / Bimatoprost 0.03%
n=12 participants at risk
low-dose drug device during first period, bimatoprost 0.03% during second period.
|
Placebo Device / Bimatoprost 0.03%
n=18 participants at risk
placebo device during first period, bimatoprost 0.03% during second period.
|
|---|---|---|---|
|
Eye disorders
Conjunctival Hyperemia
|
29.4%
5/17 • Number of events 5
|
33.3%
4/12 • Number of events 4
|
27.8%
5/18 • Number of events 5
|
|
Eye disorders
Eye Irritation
|
0.00%
0/17
|
16.7%
2/12 • Number of events 2
|
0.00%
0/18
|
|
Eye disorders
Eye Pain
|
0.00%
0/17
|
0.00%
0/12
|
5.6%
1/18 • Number of events 1
|
|
Eye disorders
Eye Pruritus
|
11.8%
2/17 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
0.00%
0/18
|
|
Eye disorders
Eyelid Pruritus
|
0.00%
0/17
|
16.7%
2/12 • Number of events 2
|
0.00%
0/18
|
|
Eye disorders
Eyelid Margin Crusting
|
0.00%
0/17
|
0.00%
0/12
|
5.6%
1/18 • Number of events 1
|
|
Eye disorders
Eyelid Oedema
|
5.9%
1/17 • Number of events 1
|
0.00%
0/12
|
5.6%
1/18 • Number of events 1
|
|
Eye disorders
Foreign Body Sensation in Eye
|
5.9%
1/17 • Number of events 1
|
8.3%
1/12 • Number of events 2
|
0.00%
0/18
|
|
Eye disorders
Punctate Keratitis
|
0.00%
0/17
|
8.3%
1/12 • Number of events 2
|
0.00%
0/18
|
|
Eye disorders
Ocular Hyperemia
|
0.00%
0/17
|
0.00%
0/12
|
5.6%
1/18 • Number of events 1
|
|
Eye disorders
Lid Margin Discharge
|
0.00%
0/17
|
0.00%
0/12
|
5.6%
1/18 • Number of events 1
|
|
Eye disorders
Abnormal Sensation in Eye
|
5.9%
1/17 • Number of events 1
|
0.00%
0/12
|
0.00%
0/18
|
|
Eye disorders
Eye Disorder
|
0.00%
0/17
|
0.00%
0/12
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/17
|
0.00%
0/12
|
5.6%
1/18 • Number of events 1
|
|
Injury, poisoning and procedural complications
Medical Device Complication
|
17.6%
3/17 • Number of events 3
|
8.3%
1/12 • Number of events 1
|
16.7%
3/18 • Number of events 3
|
|
Injury, poisoning and procedural complications
Medical Device Discomfort
|
5.9%
1/17 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
5.9%
1/17 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/17
|
8.3%
1/12 • Number of events 1
|
0.00%
0/18
|
|
Nervous system disorders
Headache
|
0.00%
0/17
|
—
0/0
|
11.1%
2/18 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
5.9%
1/17 • Number of events 1
|
0.00%
0/12
|
0.00%
0/18
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication requires written consent of the sponsor.
- Publication restrictions are in place
Restriction type: OTHER