Trial Outcomes & Findings for A Two Comparator, Controlled Phase 3 Study in Patients With and Without Evaporative Dry Eye (NCT NCT02871440)
NCT ID: NCT02871440
Last Updated: 2020-05-12
Results Overview
Measured using a Vapometer (g/m\^2\*h)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
40 participants
Primary outcome timeframe
Assessed at 4 weeks
Results posted on
2020-05-12
Participant Flow
Participant milestones
| Measure |
Eye Drop 1
Omega 3 Tear Formulation (1-2 drops in each eye for at least 2 times daily)
|
Eye Drop 2
Optive Advanced (1-2 drops in each eye for at least 2 times daily)
|
Eye Drop 3
Optive (1-2 drops in each eye for at least 2 times daily)
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
15
|
|
Overall Study
COMPLETED
|
12
|
13
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Two Comparator, Controlled Phase 3 Study in Patients With and Without Evaporative Dry Eye
Baseline characteristics by cohort
| Measure |
Eye Drop 1
n=12 Participants
Omega 3
|
Eye Drop 2
n=13 Participants
Optive Advanced
|
Eye Drop 3
n=15 Participants
Optive
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Age, Continuous
|
39.98 years
STANDARD_DEVIATION 20.07 • n=5 Participants
|
40.26 years
STANDARD_DEVIATION 20.84 • n=7 Participants
|
40.91 years
STANDARD_DEVIATION 20.69 • n=5 Participants
|
40.49 years
STANDARD_DEVIATION 20.26 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
24 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
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
14 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
15 participants
n=5 Participants
|
40 participants
n=4 Participants
|
|
Ocular Surface Disease Index
|
35.28 units on a scale
STANDARD_DEVIATION 16.26 • n=5 Participants
|
34.00 units on a scale
STANDARD_DEVIATION 14.34 • n=7 Participants
|
34.47 units on a scale
STANDARD_DEVIATION 15.67 • n=5 Participants
|
35.28 units on a scale
STANDARD_DEVIATION 16.14 • n=4 Participants
|
|
Tear Evaporation
|
78.3 g/m^2*h
STANDARD_DEVIATION 42.8 • n=5 Participants
|
67 g/m^2*h
STANDARD_DEVIATION 31.7 • n=7 Participants
|
75.3 g/m^2*h
STANDARD_DEVIATION 38.0 • n=5 Participants
|
78.0 g/m^2*h
STANDARD_DEVIATION 43.6 • n=4 Participants
|
|
Tear Break-Up Time
|
6.14 seconds
STANDARD_DEVIATION 2.73 • n=5 Participants
|
6.52 seconds
STANDARD_DEVIATION 2.95 • n=7 Participants
|
6.22 seconds
STANDARD_DEVIATION 2.74 • n=5 Participants
|
6.14 seconds
STANDARD_DEVIATION 2.73 • n=4 Participants
|
|
Tear Volume
|
13.20 mm
STANDARD_DEVIATION 9.06 • n=5 Participants
|
13.83 mm
STANDARD_DEVIATION 8.56 • n=7 Participants
|
13.48 mm
STANDARD_DEVIATION 8.93 • n=5 Participants
|
13.83 mm
STANDARD_DEVIATION 9.06 • n=4 Participants
|
PRIMARY outcome
Timeframe: Assessed at 4 weeksMeasured using a Vapometer (g/m\^2\*h)
Outcome measures
| Measure |
Eye Drop 1
n=12 Participants
Omega 3
|
Eye Drop 2
n=13 Participants
Optive Advanced
|
Eye Drop 3
n=15 Participants
Optive
|
|---|---|---|---|
|
Tear Evaporation Rate
|
77.7 g/m^2*h
Standard Deviation 42.4
|
67 g/m^2*h
Standard Deviation 31.7
|
75.3 g/m^2*h
Standard Deviation 38.0
|
SECONDARY outcome
Timeframe: Assessed at 4 weeksMeasured with fluorescein dye (seconds)
Outcome measures
| Measure |
Eye Drop 1
n=12 Participants
Omega 3
|
Eye Drop 2
n=13 Participants
Optive Advanced
|
Eye Drop 3
n=15 Participants
Optive
|
|---|---|---|---|
|
Tear Break-up Time
|
6.10 Seconds
Standard Deviation 2.76
|
6.52 Seconds
Standard Deviation 2.94
|
6.22 Seconds
Standard Deviation 2.73
|
SECONDARY outcome
Timeframe: Assessed at 4 weeksMeasured using visual analogue scales (0-100); 0 indicates no/less symptoms and 100 indicates maximum/worse symptoms.
Outcome measures
| Measure |
Eye Drop 1
n=12 Participants
Omega 3
|
Eye Drop 2
n=13 Participants
Optive Advanced
|
Eye Drop 3
n=15 Participants
Optive
|
|---|---|---|---|
|
Subjective Ocular Comfort
|
21 score on a scale
Standard Deviation 23.73
|
21 score on a scale
Standard Deviation 23.89
|
21 score on a scale
Standard Deviation 23.73
|
Adverse Events
Eye Drop 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Eye Drop 2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Eye Drop 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Eye Drop 1
n=12 participants at risk
Omega 3
|
Eye Drop 2
n=13 participants at risk
Optive Advanced
|
Eye Drop 3
n=15 participants at risk
Optive
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Bacterial Chest Infection
|
0.00%
0/12 • 4 weeks
All-cause mortality or serious adverse events were monitored/assessed. Since, total number of participants at risk will equal the number of participants started in the participant flow module, this section has been updated.
|
7.7%
1/13 • Number of events 1 • 4 weeks
All-cause mortality or serious adverse events were monitored/assessed. Since, total number of participants at risk will equal the number of participants started in the participant flow module, this section has been updated.
|
0.00%
0/15 • 4 weeks
All-cause mortality or serious adverse events were monitored/assessed. Since, total number of participants at risk will equal the number of participants started in the participant flow module, this section has been updated.
|
|
Eye disorders
Itchy and uncomfortable eyes
|
0.00%
0/12 • 4 weeks
All-cause mortality or serious adverse events were monitored/assessed. Since, total number of participants at risk will equal the number of participants started in the participant flow module, this section has been updated.
|
7.7%
1/13 • Number of events 1 • 4 weeks
All-cause mortality or serious adverse events were monitored/assessed. Since, total number of participants at risk will equal the number of participants started in the participant flow module, this section has been updated.
|
0.00%
0/15 • 4 weeks
All-cause mortality or serious adverse events were monitored/assessed. Since, total number of participants at risk will equal the number of participants started in the participant flow module, this section has been updated.
|
|
Eye disorders
Burning and Stinging in the eye
|
0.00%
0/12 • 4 weeks
All-cause mortality or serious adverse events were monitored/assessed. Since, total number of participants at risk will equal the number of participants started in the participant flow module, this section has been updated.
|
7.7%
1/13 • Number of events 1 • 4 weeks
All-cause mortality or serious adverse events were monitored/assessed. Since, total number of participants at risk will equal the number of participants started in the participant flow module, this section has been updated.
|
0.00%
0/15 • 4 weeks
All-cause mortality or serious adverse events were monitored/assessed. Since, total number of participants at risk will equal the number of participants started in the participant flow module, this section has been updated.
|
|
General disorders
Anemia and Vitamin D Deficiency
|
8.3%
1/12 • Number of events 1 • 4 weeks
All-cause mortality or serious adverse events were monitored/assessed. Since, total number of participants at risk will equal the number of participants started in the participant flow module, this section has been updated.
|
0.00%
0/13 • 4 weeks
All-cause mortality or serious adverse events were monitored/assessed. Since, total number of participants at risk will equal the number of participants started in the participant flow module, this section has been updated.
|
0.00%
0/15 • 4 weeks
All-cause mortality or serious adverse events were monitored/assessed. Since, total number of participants at risk will equal the number of participants started in the participant flow module, this section has been updated.
|
|
Eye disorders
Ocular irritation
|
0.00%
0/12 • 4 weeks
All-cause mortality or serious adverse events were monitored/assessed. Since, total number of participants at risk will equal the number of participants started in the participant flow module, this section has been updated.
|
7.7%
1/13 • Number of events 1 • 4 weeks
All-cause mortality or serious adverse events were monitored/assessed. Since, total number of participants at risk will equal the number of participants started in the participant flow module, this section has been updated.
|
6.7%
1/15 • Number of events 1 • 4 weeks
All-cause mortality or serious adverse events were monitored/assessed. Since, total number of participants at risk will equal the number of participants started in the participant flow module, this section has been updated.
|
|
Eye disorders
Lid Chalazion
|
8.3%
1/12 • Number of events 1 • 4 weeks
All-cause mortality or serious adverse events were monitored/assessed. Since, total number of participants at risk will equal the number of participants started in the participant flow module, this section has been updated.
|
0.00%
0/13 • 4 weeks
All-cause mortality or serious adverse events were monitored/assessed. Since, total number of participants at risk will equal the number of participants started in the participant flow module, this section has been updated.
|
0.00%
0/15 • 4 weeks
All-cause mortality or serious adverse events were monitored/assessed. Since, total number of participants at risk will equal the number of participants started in the participant flow module, this section has been updated.
|
|
Eye disorders
Dry white residue around the eyes 5 min after using study drops
|
8.3%
1/12 • Number of events 1 • 4 weeks
All-cause mortality or serious adverse events were monitored/assessed. Since, total number of participants at risk will equal the number of participants started in the participant flow module, this section has been updated.
|
0.00%
0/13 • 4 weeks
All-cause mortality or serious adverse events were monitored/assessed. Since, total number of participants at risk will equal the number of participants started in the participant flow module, this section has been updated.
|
0.00%
0/15 • 4 weeks
All-cause mortality or serious adverse events were monitored/assessed. Since, total number of participants at risk will equal the number of participants started in the participant flow module, this section has been updated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place