Trial Outcomes & Findings for Study to Assess the Safety and Efficacy of BOL-303242-X Ophthalmic Suspension in Dry Eye Syndrome (NCT NCT01163643)
NCT ID: NCT01163643
Last Updated: 2020-09-25
Results Overview
Total corneal staining score was calculated by adding the individual grades from 5 regions of the corneal surface (1: Central; 2: Superior; 3: Temporal; 4: Nasal; 5: Inferior). Grade 0 = none and Grade 3 = severe. The minimum total score possible was 0 and the maximum total score possible was 15. Higher scores indicated worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
356 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-09-25
Participant Flow
Participant milestones
| Measure |
2% BOL-303242-X Ophthalmic Suspension
2% BOL-303242-X ophthalmic suspension
2% BOL-303242-X ophthalmic suspension: 2% BOL-303242-X ophthalmic suspension BID for 12 weeks.
|
2% BOL-303242-X Ophthalmic Suspension in the Morning
2% BOL-303242-X ophthalmic suspension in the morning (AM) and vehicle in the afternoon (PM)
2% BOL-303242-X ophthalmic suspension AM: 2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks.
|
2% BOL-303242-X Ophthalmic Suspension PM
Vehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM.
2% BOL-303242-X ophthalmic suspension PM: Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks.
|
1% BOL-303242-X Ophthalmic Suspension
1% BOL-303242-X ophthalmic suspension
1% BOL-303242-X ophthalmic suspension: 1% BOL-303242-X ophthalmic suspension BID for 12 weeks.
|
0.3% BOL-303242-X Ophthalmic Suspension
0.3% BOL-303242-X ophthalmic suspension
0.3% BOL-303242-X ophthalmic suspension: 0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks.
|
Vehicle
Vehicle twice daily (BID)
Placebo Comparator: Vehicle: Placebo Comparator: Vehicle BID for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
68
|
37
|
35
|
74
|
69
|
73
|
|
Overall Study
COMPLETED
|
62
|
35
|
33
|
69
|
61
|
66
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
2
|
5
|
8
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Assess the Safety and Efficacy of BOL-303242-X Ophthalmic Suspension in Dry Eye Syndrome
Baseline characteristics by cohort
| Measure |
2% BOL-303242-X Ophthalmic Suspension
n=68 Participants
2% BOL-303242-X ophthalmic suspension
2% BOL-303242-X ophthalmic suspension: 2% BOL-303242-X ophthalmic suspension BID for 12 weeks.
|
2% BOL-303242-X Ophthalmic Suspension in the Morning
n=37 Participants
2% BOL-303242-X ophthalmic suspension in the morning (AM) and vehicle in the afternoon (PM)
2% BOL-303242-X ophthalmic suspension AM: 2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks.
|
2% BOL-303242-X Ophthalmic Suspension PM
n=35 Participants
Vehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM.
2% BOL-303242-X ophthalmic suspension PM: Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks.
|
1% BOL-303242-X Ophthalmic Suspension
n=74 Participants
1% BOL-303242-X ophthalmic suspension
1% BOL-303242-X ophthalmic suspension: 1% BOL-303242-X ophthalmic suspension BID for 12 weeks.
|
0.3% BOL-303242-X Ophthalmic Suspension
n=69 Participants
0.3% BOL-303242-X ophthalmic suspension
0.3% BOL-303242-X ophthalmic suspension: 0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks.
|
Vehicle
n=73 Participants
Vehicle twice daily (BID)
Placebo Comparator: Vehicle: Placebo Comparator: Vehicle BID for 12 weeks.
|
Total
n=356 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
48.6 years
STANDARD_DEVIATION 17.79 • n=5 Participants
|
50.6 years
STANDARD_DEVIATION 16.99 • n=7 Participants
|
51.8 years
STANDARD_DEVIATION 18.10 • n=5 Participants
|
46.3 years
STANDARD_DEVIATION 17.64 • n=4 Participants
|
46.5 years
STANDARD_DEVIATION 15.91 • n=21 Participants
|
49.5 years
STANDARD_DEVIATION 17.56 • n=8 Participants
|
48.4 years
STANDARD_DEVIATION 17.29 • n=8 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
50 Participants
n=8 Participants
|
242 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
114 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Randomized participants with Week 12 results were included, with no imputation of missing data at Week 12.
Total corneal staining score was calculated by adding the individual grades from 5 regions of the corneal surface (1: Central; 2: Superior; 3: Temporal; 4: Nasal; 5: Inferior). Grade 0 = none and Grade 3 = severe. The minimum total score possible was 0 and the maximum total score possible was 15. Higher scores indicated worse outcome.
Outcome measures
| Measure |
2% BOL-303242-X Ophthalmic Suspension
n=64 Participants
2% BOL-303242-X ophthalmic suspension
2% BOL-303242-X ophthalmic suspension: 2% BOL-303242-X ophthalmic suspension BID for 12 weeks.
|
2% BOL-303242-X Ophthalmic Suspension in the Morning
n=35 Participants
2% BOL-303242-X ophthalmic suspension in the morning (AM) and vehicle in the afternoon (PM)
2% BOL-303242-X ophthalmic suspension AM: 2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks.
|
2% BOL-303242-X Ophthalmic Suspension PM
n=33 Participants
Vehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM.
2% BOL-303242-X ophthalmic suspension PM: Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks.
|
1% BOL-303242-X Ophthalmic Suspension
n=71 Participants
1% BOL-303242-X ophthalmic suspension
1% BOL-303242-X ophthalmic suspension: 1% BOL-303242-X ophthalmic suspension BID for 12 weeks.
|
0.3% BOL-303242-X Ophthalmic Suspension
n=64 Participants
0.3% BOL-303242-X ophthalmic suspension
0.3% BOL-303242-X ophthalmic suspension: 0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks.
|
Vehicle
n=67 Participants
Vehicle twice daily (BID)
Placebo Comparator: Vehicle: Placebo Comparator: Vehicle BID for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Mean Corneal Staining Score
|
4.0 score on a scale
Standard Deviation 3.19
|
3.9 score on a scale
Standard Deviation 3.87
|
3.9 score on a scale
Standard Deviation 3.66
|
4.4 score on a scale
Standard Deviation 3.53
|
4.1 score on a scale
Standard Deviation 3.03
|
3.7 score on a scale
Standard Deviation 3.33
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Randomized participants with Week 12 results were included, with no imputation of missing data at Week 12.
Each symptom (ocular discomfort, dryness, grittiness, and stinging) was assessed to the nearest millimeter on a 0 - 10 cm Visual Analog Scale (VAS) by the subject. The worst VAS dry eye symptom was utilized in the analysis. The minimum for the worst symptom was 0 and the maximum for the worst symptom was 10.
Outcome measures
| Measure |
2% BOL-303242-X Ophthalmic Suspension
n=64 Participants
2% BOL-303242-X ophthalmic suspension
2% BOL-303242-X ophthalmic suspension: 2% BOL-303242-X ophthalmic suspension BID for 12 weeks.
|
2% BOL-303242-X Ophthalmic Suspension in the Morning
n=34 Participants
2% BOL-303242-X ophthalmic suspension in the morning (AM) and vehicle in the afternoon (PM)
2% BOL-303242-X ophthalmic suspension AM: 2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks.
|
2% BOL-303242-X Ophthalmic Suspension PM
n=33 Participants
Vehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM.
2% BOL-303242-X ophthalmic suspension PM: Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks.
|
1% BOL-303242-X Ophthalmic Suspension
n=71 Participants
1% BOL-303242-X ophthalmic suspension
1% BOL-303242-X ophthalmic suspension: 1% BOL-303242-X ophthalmic suspension BID for 12 weeks.
|
0.3% BOL-303242-X Ophthalmic Suspension
n=65 Participants
0.3% BOL-303242-X ophthalmic suspension
0.3% BOL-303242-X ophthalmic suspension: 0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks.
|
Vehicle
n=67 Participants
Vehicle twice daily (BID)
Placebo Comparator: Vehicle: Placebo Comparator: Vehicle BID for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Mean Worst Visual Analog Scale(VAS) Dry Eye Symptom
|
2.256 score on a scale
Standard Deviation 2.3172
|
2.954 score on a scale
Standard Deviation 2.4688
|
2.290 score on a scale
Standard Deviation 2.4885
|
2.407 score on a scale
Standard Deviation 2.6070
|
2.535 score on a scale
Standard Deviation 2.5565
|
2.026 score on a scale
Standard Deviation 2.1849
|
Adverse Events
2% BOL-303242-X Ophthalmic Suspension
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
2% BOL-303242-X Ophthalmic Suspension in the Morning
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
2% BOL-303242-X Ophthalmic Suspension PM
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
1% BOL-303242-X Ophthalmic Suspension
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
0.3% BOL-303242-X Ophthalmic Suspension
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
2% BOL-303242-X Ophthalmic Suspension
n=67 participants at risk
2% BOL-303242-X ophthalmic suspension
2% BOL-303242-X ophthalmic suspension: 2% BOL-303242-X ophthalmic suspension BID for 12 weeks.
|
2% BOL-303242-X Ophthalmic Suspension in the Morning
n=37 participants at risk
2% BOL-303242-X ophthalmic suspension in the morning (AM) and vehicle in the afternoon (PM)
2% BOL-303242-X ophthalmic suspension AM: 2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks.
|
2% BOL-303242-X Ophthalmic Suspension PM
n=34 participants at risk
Vehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM.
2% BOL-303242-X ophthalmic suspension PM: Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks.
|
1% BOL-303242-X Ophthalmic Suspension
n=73 participants at risk
1% BOL-303242-X ophthalmic suspension
1% BOL-303242-X ophthalmic suspension: 1% BOL-303242-X ophthalmic suspension BID for 12 weeks.
|
0.3% BOL-303242-X Ophthalmic Suspension
n=69 participants at risk
0.3% BOL-303242-X ophthalmic suspension
0.3% BOL-303242-X ophthalmic suspension: 0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks.
|
Vehicle
n=71 participants at risk
Vehicle twice daily (BID)
Placebo Comparator: Vehicle: Placebo Comparator: Vehicle BID for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Urinary Tract Infection
|
1.5%
1/67 • 12 weeks
The safety population included participants who received at least 1 dose of study drug. Participants confirmed to have never took a dose of study drug were excluded from safety analyses. Of the randomized participants, there was one 2% BOL-303242-X Ophthalmic Suspension participant, one 2% BOL-303242-X Ophthalmic Suspension PM participant, one 1% BOL-303242-X Ophthalmic Suspension participant, and 2 Vehicle participants who did not take at least one dose of study drug.
|
5.4%
2/37 • 12 weeks
The safety population included participants who received at least 1 dose of study drug. Participants confirmed to have never took a dose of study drug were excluded from safety analyses. Of the randomized participants, there was one 2% BOL-303242-X Ophthalmic Suspension participant, one 2% BOL-303242-X Ophthalmic Suspension PM participant, one 1% BOL-303242-X Ophthalmic Suspension participant, and 2 Vehicle participants who did not take at least one dose of study drug.
|
2.9%
1/34 • 12 weeks
The safety population included participants who received at least 1 dose of study drug. Participants confirmed to have never took a dose of study drug were excluded from safety analyses. Of the randomized participants, there was one 2% BOL-303242-X Ophthalmic Suspension participant, one 2% BOL-303242-X Ophthalmic Suspension PM participant, one 1% BOL-303242-X Ophthalmic Suspension participant, and 2 Vehicle participants who did not take at least one dose of study drug.
|
2.7%
2/73 • 12 weeks
The safety population included participants who received at least 1 dose of study drug. Participants confirmed to have never took a dose of study drug were excluded from safety analyses. Of the randomized participants, there was one 2% BOL-303242-X Ophthalmic Suspension participant, one 2% BOL-303242-X Ophthalmic Suspension PM participant, one 1% BOL-303242-X Ophthalmic Suspension participant, and 2 Vehicle participants who did not take at least one dose of study drug.
|
4.3%
3/69 • 12 weeks
The safety population included participants who received at least 1 dose of study drug. Participants confirmed to have never took a dose of study drug were excluded from safety analyses. Of the randomized participants, there was one 2% BOL-303242-X Ophthalmic Suspension participant, one 2% BOL-303242-X Ophthalmic Suspension PM participant, one 1% BOL-303242-X Ophthalmic Suspension participant, and 2 Vehicle participants who did not take at least one dose of study drug.
|
7.0%
5/71 • 12 weeks
The safety population included participants who received at least 1 dose of study drug. Participants confirmed to have never took a dose of study drug were excluded from safety analyses. Of the randomized participants, there was one 2% BOL-303242-X Ophthalmic Suspension participant, one 2% BOL-303242-X Ophthalmic Suspension PM participant, one 1% BOL-303242-X Ophthalmic Suspension participant, and 2 Vehicle participants who did not take at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Contact sponsor directly for details.
- Publication restrictions are in place
Restriction type: OTHER