Trial Outcomes & Findings for Evaluation of BOL-303242-X Versus Vehicle for the Treatment of Inflammation Following Cataract Surgery (NCT NCT00905450)
NCT ID: NCT00905450
Last Updated: 2020-09-22
Results Overview
Anterior chamber (AC) cells will be assessed using a 0 to 4 grading scale by an ophthalmologist using slip lamp biomicroscopy. A slit lamp examination of the lids, conjunctiva, limbus, cornea, anterior chamber, vitreous, and lens was performed without pupil dilation. Accumulation of white blood cells in aqueous was assessed. Pigment cells and red blood cells are to be ignored. The grades were defined as: 0 = No cells seen; 1 = 1 - 5 cells; 2 = 6 - 15 cells; 3 = 16 - 30 cells; 4 = \>30 cells. Complete resolution of AC cells was defined as Grade 0.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
415 participants
Primary outcome timeframe
8 days
Results posted on
2020-09-22
Participant Flow
Participant milestones
| Measure |
1% Twice a Day
BOL-303242-X ophthalmic suspension 1% Twice a Day
|
2% Once a Day
BOL-303242-X ophthalmic suspension 2% Once a Day
|
2% Twice a Day
BOL-303242-X ophthalmic suspension 2% Twice a Day
|
2% Four Times a Day
BOL-303242-X ophthalmic suspension 2% Four times a Day
|
3% Once a Day
BOL-303242-X ophthalmic suspension 3% Once a Day
|
3% Twice a Day
BOL-303242-X ophthalmic suspension 3% Twice a Day
|
3% Four Times a Day
BOL-303242-X ophthalmic suspension 3% Four times a Day
|
Vehicle
Vehicle for BOL-303242-X ophthalmic suspension
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
60
|
28
|
28
|
60
|
59
|
60
|
60
|
60
|
|
Overall Study
COMPLETED
|
59
|
27
|
28
|
60
|
59
|
58
|
58
|
59
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
0
|
0
|
2
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of BOL-303242-X Versus Vehicle for the Treatment of Inflammation Following Cataract Surgery
Baseline characteristics by cohort
| Measure |
1% Twice a Day
n=60 Participants
BOL-303242-X ophthalmic suspension 1% Twice a Day
|
2% Once a Day
n=28 Participants
BOL-303242-X ophthalmic suspension 2% Once a Day
|
2% Twice a Day
n=28 Participants
BOL-303242-X ophthalmic suspension 2% Twice a Day
|
2% Four Times a Day
n=60 Participants
BOL-303242-X ophthalmic suspension 2% Four times a Day
|
3% Once a Day
n=59 Participants
BOL-303242-X ophthalmic suspension 3% Once a Day
|
3% Twice a Day
n=60 Participants
BOL-303242-X ophthalmic suspension 3% Twice a Day
|
3% Four Times a Day
n=60 Participants
BOL-303242-X ophthalmic suspension 3% Four times a Day
|
Vehicle
n=60 Participants
Vehicle for BOL-303242-X ophthalmic suspension
|
Total
n=415 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
65.4 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
67.9 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
68.9 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
69.5 years
STANDARD_DEVIATION 7.1 • n=4 Participants
|
68.2 years
STANDARD_DEVIATION 10.8 • n=21 Participants
|
67.3 years
STANDARD_DEVIATION 10.7 • n=8 Participants
|
68.5 years
STANDARD_DEVIATION 10.3 • n=8 Participants
|
67.1 years
STANDARD_DEVIATION 10.8 • n=24 Participants
|
67.8 years
STANDARD_DEVIATION 10.4 • n=42 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
31 Participants
n=8 Participants
|
32 Participants
n=24 Participants
|
222 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
28 Participants
n=8 Participants
|
29 Participants
n=8 Participants
|
28 Participants
n=24 Participants
|
193 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 8 daysAnterior chamber (AC) cells will be assessed using a 0 to 4 grading scale by an ophthalmologist using slip lamp biomicroscopy. A slit lamp examination of the lids, conjunctiva, limbus, cornea, anterior chamber, vitreous, and lens was performed without pupil dilation. Accumulation of white blood cells in aqueous was assessed. Pigment cells and red blood cells are to be ignored. The grades were defined as: 0 = No cells seen; 1 = 1 - 5 cells; 2 = 6 - 15 cells; 3 = 16 - 30 cells; 4 = \>30 cells. Complete resolution of AC cells was defined as Grade 0.
Outcome measures
| Measure |
1% Twice a Day
n=60 Participants
BOL-303242-X ophthalmic suspension 1% Twice a Day
|
2% Once a Day
n=28 Participants
BOL-303242-X ophthalmic suspension 2% Once a Day
|
2% Twice a Day
n=28 Participants
BOL-303242-X ophthalmic suspension 2% Twice a Day
|
2% Four Times a Day
n=60 Participants
BOL-303242-X ophthalmic suspension 2% Four times a Day
|
3% Once a Day
n=59 Participants
BOL-303242-X ophthalmic suspension 3% Once a Day
|
3% Twice a Day
n=60 Participants
BOL-303242-X ophthalmic suspension 3% Twice a Day
|
3% Four Times a Day
n=60 Participants
BOL-303242-X ophthalmic suspension 3% Four times a Day
|
Vehicle
n=60 Participants
Vehicle for BOL-303242-X ophthalmic suspension
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.
|
35 Participants
|
19 Participants
|
15 Participants
|
47 Participants
|
42 Participants
|
45 Participants
|
42 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: 8 daysA slit lamp examination of the lids, conjunctiva, limbus, cornea, anterior chamber, vitreous, and lens will be performed without pupil dilation. Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). The grades for flare were 0=None to 4=Very Severe effect. Complete resolution of AC flare was defined as Grade 0.
Outcome measures
| Measure |
1% Twice a Day
n=60 Participants
BOL-303242-X ophthalmic suspension 1% Twice a Day
|
2% Once a Day
n=28 Participants
BOL-303242-X ophthalmic suspension 2% Once a Day
|
2% Twice a Day
n=28 Participants
BOL-303242-X ophthalmic suspension 2% Twice a Day
|
2% Four Times a Day
n=60 Participants
BOL-303242-X ophthalmic suspension 2% Four times a Day
|
3% Once a Day
n=59 Participants
BOL-303242-X ophthalmic suspension 3% Once a Day
|
3% Twice a Day
n=60 Participants
BOL-303242-X ophthalmic suspension 3% Twice a Day
|
3% Four Times a Day
n=60 Participants
BOL-303242-X ophthalmic suspension 3% Four times a Day
|
Vehicle
n=60 Participants
Vehicle for BOL-303242-X ophthalmic suspension
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare.
|
15 Participants
|
6 Participants
|
7 Participants
|
18 Participants
|
21 Participants
|
23 Participants
|
18 Participants
|
11 Participants
|
Adverse Events
1% Twice a Day
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
2% Once a Day
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
2% Twice a Day
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
2% Four Times a Day
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
3% Once a Day
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
3% Twice a Day
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
3% Four Times a Day
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1% Twice a Day
n=60 participants at risk
BOL-303242-X ophthalmic suspension 1% Twice a Day
|
2% Once a Day
n=28 participants at risk
BOL-303242-X ophthalmic suspension 2% Once a Day
|
2% Twice a Day
n=28 participants at risk
BOL-303242-X ophthalmic suspension 2% Twice a Day
|
2% Four Times a Day
n=60 participants at risk
BOL-303242-X ophthalmic suspension 2% Four times a Day
|
3% Once a Day
n=59 participants at risk
BOL-303242-X ophthalmic suspension 3% Once a Day
|
3% Twice a Day
n=60 participants at risk
BOL-303242-X ophthalmic suspension 3% Twice a Day
|
3% Four Times a Day
n=60 participants at risk
BOL-303242-X ophthalmic suspension 3% Four times a Day
|
Vehicle
n=60 participants at risk
Vehicle for BOL-303242-X ophthalmic suspension
|
|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Cystoid macular edema
|
0.00%
0/60 • 18 days
|
0.00%
0/28 • 18 days
|
0.00%
0/28 • 18 days
|
0.00%
0/60 • 18 days
|
1.7%
1/59 • 18 days
|
0.00%
0/60 • 18 days
|
0.00%
0/60 • 18 days
|
0.00%
0/60 • 18 days
|
|
Eye disorders
Subretinal neovascularization
|
0.00%
0/60 • 18 days
|
0.00%
0/28 • 18 days
|
0.00%
0/28 • 18 days
|
0.00%
0/60 • 18 days
|
0.00%
0/59 • 18 days
|
1.7%
1/60 • 18 days
|
0.00%
0/60 • 18 days
|
0.00%
0/60 • 18 days
|
Other adverse events
| Measure |
1% Twice a Day
n=60 participants at risk
BOL-303242-X ophthalmic suspension 1% Twice a Day
|
2% Once a Day
n=28 participants at risk
BOL-303242-X ophthalmic suspension 2% Once a Day
|
2% Twice a Day
n=28 participants at risk
BOL-303242-X ophthalmic suspension 2% Twice a Day
|
2% Four Times a Day
n=60 participants at risk
BOL-303242-X ophthalmic suspension 2% Four times a Day
|
3% Once a Day
n=59 participants at risk
BOL-303242-X ophthalmic suspension 3% Once a Day
|
3% Twice a Day
n=60 participants at risk
BOL-303242-X ophthalmic suspension 3% Twice a Day
|
3% Four Times a Day
n=60 participants at risk
BOL-303242-X ophthalmic suspension 3% Four times a Day
|
Vehicle
n=60 participants at risk
Vehicle for BOL-303242-X ophthalmic suspension
|
|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
3.3%
2/60 • 18 days
|
0.00%
0/28 • 18 days
|
0.00%
0/28 • 18 days
|
6.7%
4/60 • 18 days
|
1.7%
1/59 • 18 days
|
1.7%
1/60 • 18 days
|
0.00%
0/60 • 18 days
|
0.00%
0/60 • 18 days
|
|
Eye disorders
Eye pain
|
11.7%
7/60 • 18 days
|
14.3%
4/28 • 18 days
|
7.1%
2/28 • 18 days
|
0.00%
0/60 • 18 days
|
5.1%
3/59 • 18 days
|
3.3%
2/60 • 18 days
|
3.3%
2/60 • 18 days
|
10.0%
6/60 • 18 days
|
|
Eye disorders
Photophobia
|
11.7%
7/60 • 18 days
|
14.3%
4/28 • 18 days
|
0.00%
0/28 • 18 days
|
1.7%
1/60 • 18 days
|
1.7%
1/59 • 18 days
|
6.7%
4/60 • 18 days
|
6.7%
4/60 • 18 days
|
8.3%
5/60 • 18 days
|
|
Eye disorders
AC Inflammation
|
3.3%
2/60 • 18 days
|
3.6%
1/28 • 18 days
|
0.00%
0/28 • 18 days
|
3.3%
2/60 • 18 days
|
1.7%
1/59 • 18 days
|
5.0%
3/60 • 18 days
|
3.3%
2/60 • 18 days
|
6.7%
4/60 • 18 days
|
|
Eye disorders
Ocular hyperaemia
|
8.3%
5/60 • 18 days
|
3.6%
1/28 • 18 days
|
0.00%
0/28 • 18 days
|
1.7%
1/60 • 18 days
|
1.7%
1/59 • 18 days
|
3.3%
2/60 • 18 days
|
5.0%
3/60 • 18 days
|
3.3%
2/60 • 18 days
|
|
Eye disorders
Lacrimation increased
|
5.0%
3/60 • 18 days
|
7.1%
2/28 • 18 days
|
0.00%
0/28 • 18 days
|
3.3%
2/60 • 18 days
|
1.7%
1/59 • 18 days
|
3.3%
2/60 • 18 days
|
3.3%
2/60 • 18 days
|
3.3%
2/60 • 18 days
|
|
Eye disorders
Corneal edema
|
3.3%
2/60 • 18 days
|
14.3%
4/28 • 18 days
|
3.6%
1/28 • 18 days
|
1.7%
1/60 • 18 days
|
0.00%
0/59 • 18 days
|
1.7%
1/60 • 18 days
|
1.7%
1/60 • 18 days
|
5.0%
3/60 • 18 days
|
|
Eye disorders
Foreign body sensation in eyes
|
6.7%
4/60 • 18 days
|
0.00%
0/28 • 18 days
|
0.00%
0/28 • 18 days
|
1.7%
1/60 • 18 days
|
0.00%
0/59 • 18 days
|
3.3%
2/60 • 18 days
|
5.0%
3/60 • 18 days
|
3.3%
2/60 • 18 days
|
|
Eye disorders
Dry eye
|
5.0%
3/60 • 18 days
|
7.1%
2/28 • 18 days
|
0.00%
0/28 • 18 days
|
1.7%
1/60 • 18 days
|
0.00%
0/59 • 18 days
|
3.3%
2/60 • 18 days
|
1.7%
1/60 • 18 days
|
0.00%
0/60 • 18 days
|
|
Eye disorders
Eye pruritis
|
6.7%
4/60 • 18 days
|
7.1%
2/28 • 18 days
|
0.00%
0/28 • 18 days
|
0.00%
0/60 • 18 days
|
1.7%
1/59 • 18 days
|
1.7%
1/60 • 18 days
|
1.7%
1/60 • 18 days
|
0.00%
0/60 • 18 days
|
|
Eye disorders
Iritis
|
0.00%
0/60 • 18 days
|
0.00%
0/28 • 18 days
|
3.6%
1/28 • 18 days
|
1.7%
1/60 • 18 days
|
1.7%
1/59 • 18 days
|
1.7%
1/60 • 18 days
|
1.7%
1/60 • 18 days
|
6.7%
4/60 • 18 days
|
|
Eye disorders
Conjunctival hyperemia
|
1.7%
1/60 • 18 days
|
0.00%
0/28 • 18 days
|
3.6%
1/28 • 18 days
|
0.00%
0/60 • 18 days
|
1.7%
1/59 • 18 days
|
0.00%
0/60 • 18 days
|
0.00%
0/60 • 18 days
|
5.0%
3/60 • 18 days
|
|
Eye disorders
AC Flare
|
0.00%
0/60 • 18 days
|
0.00%
0/28 • 18 days
|
7.1%
2/28 • 18 days
|
0.00%
0/60 • 18 days
|
0.00%
0/59 • 18 days
|
0.00%
0/60 • 18 days
|
0.00%
0/60 • 18 days
|
5.0%
3/60 • 18 days
|
|
Eye disorders
Eye inflammation
|
0.00%
0/60 • 18 days
|
0.00%
0/28 • 18 days
|
0.00%
0/28 • 18 days
|
0.00%
0/60 • 18 days
|
0.00%
0/59 • 18 days
|
5.0%
3/60 • 18 days
|
0.00%
0/60 • 18 days
|
0.00%
0/60 • 18 days
|
|
Eye disorders
Ciliary hyperemia
|
1.7%
1/60 • 18 days
|
0.00%
0/28 • 18 days
|
0.00%
0/28 • 18 days
|
3.3%
2/60 • 18 days
|
0.00%
0/59 • 18 days
|
5.0%
3/60 • 18 days
|
0.00%
0/60 • 18 days
|
0.00%
0/60 • 18 days
|
|
Investigations
Intraocular pressure increased
|
3.3%
2/60 • 18 days
|
0.00%
0/28 • 18 days
|
0.00%
0/28 • 18 days
|
3.3%
2/60 • 18 days
|
0.00%
0/59 • 18 days
|
1.7%
1/60 • 18 days
|
1.7%
1/60 • 18 days
|
5.0%
3/60 • 18 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Contact sponsor directly for details.
- Publication restrictions are in place
Restriction type: OTHER