Trial Outcomes & Findings for Safety and Efficacy of a Glaucoma Drug Delivery System (NCT NCT00824720)
NCT ID: NCT00824720
Last Updated: 2015-03-06
Results Overview
This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR). The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
at 14 days
Results posted on
2015-03-06
Participant Flow
Participant milestones
| Measure |
High Dose Bimatoprost Punctal Plug
punctal plug with bimatoprost, high dose
|
Low Dose Bimatoprost Punctal Plug
punctal plug with bimatoprost, low dose
|
Placebo
punctal plug without bimatoprost
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
16
|
20
|
|
Overall Study
COMPLETED
|
16
|
15
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
1
|
Reasons for withdrawal
| Measure |
High Dose Bimatoprost Punctal Plug
punctal plug with bimatoprost, high dose
|
Low Dose Bimatoprost Punctal Plug
punctal plug with bimatoprost, low dose
|
Placebo
punctal plug without bimatoprost
|
|---|---|---|---|
|
Overall Study
failed plug insertion
|
3
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy of a Glaucoma Drug Delivery System
Baseline characteristics by cohort
| Measure |
High Dose Bimatoprost Punctal Plug
n=16 Participants
punctal plug with bimatoprost, high dose
|
Low Dose Bimatoprost Punctal Plug
n=15 Participants
punctal plug with bimatoprost, low dose
|
Placebo
n=20 Participants
punctal plug without bimatoprost
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.7 years
STANDARD_DEVIATION 13.4 • n=99 Participants
|
64.6 years
STANDARD_DEVIATION 12.9 • n=107 Participants
|
64.5 years
STANDARD_DEVIATION 10.6 • n=206 Participants
|
65.2 years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
31 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: at 14 daysThis outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR). The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Outcome measures
| Measure |
High Dose Bimatoprost Punctal Plug
n=14 Participants
punctal plug with bimatoprost, high dose
|
Low Dose Bimatoprost Punctal Plug
n=15 Participants
punctal plug with bimatoprost, low dose
|
Placebo
n=19 Participants
punctal plug without bimatoprost
|
|---|---|---|---|
|
Visual Acuity - Right Eye
|
0.015 logMAR units
Standard Deviation 0.046
|
-0.044 logMAR units
Standard Deviation 0.092
|
-0.012 logMAR units
Standard Deviation 0.044
|
PRIMARY outcome
Timeframe: at 14 daysThis outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR. The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Outcome measures
| Measure |
High Dose Bimatoprost Punctal Plug
n=14 Participants
punctal plug with bimatoprost, high dose
|
Low Dose Bimatoprost Punctal Plug
n=15 Participants
punctal plug with bimatoprost, low dose
|
Placebo
n=19 Participants
punctal plug without bimatoprost
|
|---|---|---|---|
|
Visual Acuity - Left Eye
|
-0.011 logMARs
Standard Deviation 0.081
|
-0.008 logMARs
Standard Deviation 0.101
|
-0.019 logMARs
Standard Deviation 0.044
|
SECONDARY outcome
Timeframe: from baseline to 14 daysPopulation: The analysis population includes all subjects with a plug insertion that completed the study per protocol.
Outcome measures
| Measure |
High Dose Bimatoprost Punctal Plug
n=14 Participants
punctal plug with bimatoprost, high dose
|
Low Dose Bimatoprost Punctal Plug
n=15 Participants
punctal plug with bimatoprost, low dose
|
Placebo
n=19 Participants
punctal plug without bimatoprost
|
|---|---|---|---|
|
Intraocular Pressure (IOP)
|
-1.9 mmHg
Standard Deviation 2.3
|
-2.2 mmHg
Standard Deviation 3.5
|
-1.3 mmHg
Standard Deviation 3.6
|
Adverse Events
High Dose Bimatoprost Punctal Plug
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Low Dose Bimatoprost Punctal Plug
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High Dose Bimatoprost Punctal Plug
n=16 participants at risk
punctal plug with bimatoprost, high dose
|
Low Dose Bimatoprost Punctal Plug
n=15 participants at risk
punctal plug with bimatoprost, low dose
|
Placebo
n=20 participants at risk
punctal plug without bimatoprost
|
|---|---|---|---|
|
Nervous system disorders
cerebrovascular accident
|
6.2%
1/16
|
0.00%
0/15
|
0.00%
0/20
|
Other adverse events
| Measure |
High Dose Bimatoprost Punctal Plug
n=16 participants at risk
punctal plug with bimatoprost, high dose
|
Low Dose Bimatoprost Punctal Plug
n=15 participants at risk
punctal plug with bimatoprost, low dose
|
Placebo
n=20 participants at risk
punctal plug without bimatoprost
|
|---|---|---|---|
|
Eye disorders
Foreign body sensation
|
50.0%
8/16
|
33.3%
5/15
|
15.0%
3/20
|
|
Eye disorders
Eye pain
|
37.5%
6/16
|
13.3%
2/15
|
5.0%
1/20
|
|
Eye disorders
abnormal sensation in eyes
|
31.2%
5/16
|
20.0%
3/15
|
20.0%
4/20
|
|
Eye disorders
Conjunctival hyperaemia
|
18.8%
3/16
|
33.3%
5/15
|
10.0%
2/20
|
|
Eye disorders
corneal erosion
|
31.2%
5/16
|
13.3%
2/15
|
0.00%
0/20
|
|
Eye disorders
dry eye
|
18.8%
3/16
|
13.3%
2/15
|
0.00%
0/20
|
|
Eye disorders
erythema of eyelid
|
6.2%
1/16
|
0.00%
0/15
|
0.00%
0/20
|
|
Eye disorders
eye irritation
|
6.2%
1/16
|
0.00%
0/15
|
0.00%
0/20
|
|
Eye disorders
eye puritus
|
0.00%
0/16
|
0.00%
0/15
|
5.0%
1/20
|
|
Eye disorders
eyelid margin crusting
|
25.0%
4/16
|
6.7%
1/15
|
10.0%
2/20
|
|
Eye disorders
eyelid pain
|
31.2%
5/16
|
13.3%
2/15
|
5.0%
1/20
|
|
Eye disorders
eyelids puritus
|
0.00%
0/16
|
0.00%
0/15
|
5.0%
1/20
|
|
Eye disorders
inflammation of lacrimal passage
|
31.2%
5/16
|
26.7%
4/15
|
10.0%
2/20
|
|
Eye disorders
lacrimation increased
|
12.5%
2/16
|
33.3%
5/15
|
20.0%
4/20
|
|
Eye disorders
ocular hyperaemia
|
18.8%
3/16
|
13.3%
2/15
|
0.00%
0/20
|
|
Eye disorders
visual acuity reduced
|
0.00%
0/16
|
0.00%
0/15
|
5.0%
1/20
|
|
Infections and infestations
upper respiratory tract infection
|
0.00%
0/16
|
6.7%
1/15
|
0.00%
0/20
|
|
Injury, poisoning and procedural complications
contusion
|
0.00%
0/16
|
6.7%
1/15
|
0.00%
0/20
|
|
Injury, poisoning and procedural complications
procedural complication
|
6.2%
1/16
|
0.00%
0/15
|
10.0%
2/20
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal chest pain
|
0.00%
0/16
|
0.00%
0/15
|
5.0%
1/20
|
|
Nervous system disorders
sinus headache
|
0.00%
0/16
|
0.00%
0/15
|
5.0%
1/20
|
Additional Information
Brian Schwam MD/Director Clinical Affairs & Ocular Sciences
Vistakon
Phone: 904-443-1482
Results disclosure agreements
- Principal investigator is a sponsor employee Prior to submission for publication or presentation, the PI will provide the Sponsor 60 days for review of the manuscript. The Sponsor may request that the PI withhold the publication for an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER