Trial Outcomes & Findings for Safety and Efficacy of CBT-001 Ophthalmic Solution in Patients With Pterygium (NCT NCT03049852)
NCT ID: NCT03049852
Last Updated: 2020-02-24
Results Overview
The primary efficacy variable is the change from baseline (Day 1) in severity grade of pterygium vascularity at Week 4. Pterygium vascularity intensity is based on color coordinates as measured by digital image analysis of pterygium photographs. The quantitative analysis of photographs using a 5-point Pterygium Hyperemia Grading Scale (0 = absent, 1 = trace, 2 = mild, 3 = moderate, 4 = severe) will be conducted at an independent image reading center.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
75 participants
Primary outcome timeframe
Change from baseline at 4 weeks
Results posted on
2020-02-24
Participant Flow
Participant milestones
| Measure |
CBT-001 Ophthalmic Solution Single Dose
CBT-001 Ophthalmic Solution Single dose in one day
|
Vehicle Multi-dose
One drop in the study administered three times daily (TID) for 4 weeks
|
CBT-001 Ophthalmic Solution Multi-dose
One drop in the study administered three times daily (TID) for 4 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
25
|
26
|
|
Overall Study
COMPLETED
|
24
|
24
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
CBT-001 Ophthalmic Solution Single Dose
CBT-001 Ophthalmic Solution Single dose in one day
|
Vehicle Multi-dose
One drop in the study administered three times daily (TID) for 4 weeks
|
CBT-001 Ophthalmic Solution Multi-dose
One drop in the study administered three times daily (TID) for 4 weeks
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of CBT-001 Ophthalmic Solution in Patients With Pterygium
Baseline characteristics by cohort
| Measure |
CBT-001 Ophthalmic Solution Single Dose
n=24 Participants
One drop in the study administered one time
CBT-001: One drop in the study administered one time
|
Vehicle Multi-dose
n=25 Participants
One drop in the study administered three times daily (TID) for 4 weeks
Vehicle: One drop in the study administered three times daily (TID) for 4 weeks
|
CBT-001 Ophthalmic Solution Multi-dose
n=26 Participants
One drop in the study administered three times daily (TID) for 4 weeks
CBT-001: One drop in the study administered three times daily (TID) for 4 weeks
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.8 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
49.4 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
52.0 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
50.7 years
STANDARD_DEVIATION 11.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
25 participants
n=7 Participants
|
26 participants
n=5 Participants
|
75 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Change from baseline at 4 weeksPopulation: Modified Intent-to-Treat Population
The primary efficacy variable is the change from baseline (Day 1) in severity grade of pterygium vascularity at Week 4. Pterygium vascularity intensity is based on color coordinates as measured by digital image analysis of pterygium photographs. The quantitative analysis of photographs using a 5-point Pterygium Hyperemia Grading Scale (0 = absent, 1 = trace, 2 = mild, 3 = moderate, 4 = severe) will be conducted at an independent image reading center.
Outcome measures
| Measure |
Vehicle Multi-dose
n=23 Participants
One drop in the study administered three times daily (TID)
Vehicle: One drop in the study administered three times daily (TID) for 4 weeks
|
CBT-001 Ophthalmic Solution Multi-dose
n=25 Participants
One drop in the study administered three times daily (TID)
CBT-001: One drop in the study administered three times daily (TID) for 4 weeks
|
|---|---|---|
|
Pterygium Vascularity Change Assessed Using the Pterygium Hyperemia Grading Scale
|
0 grade
Standard Deviation 0.5
|
-0.8 grade
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: One dayPopulation: mITT
The ocular safety and tolerability are measured by biomicroscopy, ophthalmoscopy, intraocular pressure and visual acuity, and to assess general safety by physical exams, vital signs, clinical laboratory tests and adverse events reporting
Outcome measures
| Measure |
Vehicle Multi-dose
n=24 Participants
One drop in the study administered three times daily (TID)
Vehicle: One drop in the study administered three times daily (TID) for 4 weeks
|
CBT-001 Ophthalmic Solution Multi-dose
One drop in the study administered three times daily (TID)
CBT-001: One drop in the study administered three times daily (TID) for 4 weeks
|
|---|---|---|
|
Ocular and General Safety and Tolerability
Mild eye irritation
|
3 participants
|
—
|
|
Ocular and General Safety and Tolerability
Mild foreign body sensation
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Modified Intent-to-Treat Population
The Corneal Pterygium Lesion Length is measured from digital images of the eye by an independent image reading center.
Outcome measures
| Measure |
Vehicle Multi-dose
n=25 Participants
One drop in the study administered three times daily (TID)
Vehicle: One drop in the study administered three times daily (TID) for 4 weeks
|
CBT-001 Ophthalmic Solution Multi-dose
n=23 Participants
One drop in the study administered three times daily (TID)
CBT-001: One drop in the study administered three times daily (TID) for 4 weeks
|
|---|---|---|
|
Corneal Pterygium Lesion Length Change From Baseline
|
-0.11 mm
Standard Deviation 0.3
|
0.16 mm
Standard Deviation 0.36
|
Adverse Events
CBT-001 Ophthalmic Solution Single Dose
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Vehicle Multi-dose
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
CBT-001 Ophthalmic Solution Multi-dose
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CBT-001 Ophthalmic Solution Single Dose
n=24 participants at risk
One drop in the study administered one time
One drop in the study administered one time in one day
|
Vehicle Multi-dose
n=25 participants at risk
One drop in the study administered three times daily (TID)
Vehicle: One drop in the study administered three times daily (TID) for 4 weeks
|
CBT-001 Ophthalmic Solution Multi-dose
n=26 participants at risk
One drop in the study administered three times daily (TID)
CBT-001: One drop in the study administered three times daily (TID) for 4 weeks
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Transient ischaemic attack
|
0.00%
0/24 • 6 months
|
4.0%
1/25 • Number of events 1 • 6 months
|
0.00%
0/26 • 6 months
|
Other adverse events
| Measure |
CBT-001 Ophthalmic Solution Single Dose
n=24 participants at risk
One drop in the study administered one time
One drop in the study administered one time in one day
|
Vehicle Multi-dose
n=25 participants at risk
One drop in the study administered three times daily (TID)
Vehicle: One drop in the study administered three times daily (TID) for 4 weeks
|
CBT-001 Ophthalmic Solution Multi-dose
n=26 participants at risk
One drop in the study administered three times daily (TID)
CBT-001: One drop in the study administered three times daily (TID) for 4 weeks
|
|---|---|---|---|
|
Eye disorders
Conjunctival Discoloration
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
53.8%
14/26 • 6 months
|
|
Eye disorders
Foreign Body Sensation in Eyes
|
4.2%
1/24 • Number of events 1 • 6 months
|
0.00%
0/25 • 6 months
|
7.7%
2/26 • 6 months
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
7.7%
2/26 • 6 months
|
|
General disorders
Dysgeusia
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
7.7%
2/26 • 6 months
|
|
Infections and infestations
Influenza A infection
|
0.00%
0/24 • 6 months
|
8.0%
2/25 • 6 months
|
0.00%
0/26 • 6 months
|
|
Eye disorders
Eye irritation
|
12.5%
3/24 • Number of events 3 • 6 months
|
0.00%
0/25 • 6 months
|
0.00%
0/26 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place