Trial Outcomes & Findings for Phase 3 Study of the Safety and Efficacy of OmegaD Softgels in the Treatment of Dry Eye Disease (NCT NCT04181593)
NCT ID: NCT04181593
Last Updated: 2024-07-29
Results Overview
Mean change from baseline in tear osmolarity to Day 84 in the study eye. One eye (the designated study eye) was was analyzed for each participant. Lower values in tear osmolarity are considered to be better, therefore the larger the number for the change from baseline to Day 84 is considered to be better.
COMPLETED
PHASE3
322 participants
84 days
2024-07-29
Participant Flow
Participant milestones
| Measure |
OmegaD
OmegaD Softgels
Omega 3 fatty acid Softgels. 4 Softgels administered daily at bedtime
|
Placebo
Placebo Softgels
Mineral oil Softgels, 4 Softgels administered daily at bedtime
|
|---|---|---|
|
Overall Study
STARTED
|
157
|
165
|
|
Overall Study
COMPLETED
|
157
|
165
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 3 Study of the Safety and Efficacy of OmegaD Softgels in the Treatment of Dry Eye Disease
Baseline characteristics by cohort
| Measure |
OmegaD
n=157 Participants
OmegaD Softgels
Omega 3 fatty acid: Omega 3 fatty acid Softgels
|
Placebo
n=165 Participants
Placebo Softgels
Placebos: Mineral oil Softgels
|
Total
n=322 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.5 years
STANDARD_DEVIATION 13.4 • n=99 Participants
|
56.5 years
STANDARD_DEVIATION 14.0 • n=107 Participants
|
57.0 years
STANDARD_DEVIATION 1.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
128 Participants
n=99 Participants
|
140 Participants
n=107 Participants
|
268 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
37 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
109 Participants
n=99 Participants
|
118 Participants
n=107 Participants
|
227 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
157 Participants
n=99 Participants
|
165 Participants
n=107 Participants
|
322 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 84 daysPopulation: Mean change from baseline to Day 84
Mean change from baseline in tear osmolarity to Day 84 in the study eye. One eye (the designated study eye) was was analyzed for each participant. Lower values in tear osmolarity are considered to be better, therefore the larger the number for the change from baseline to Day 84 is considered to be better.
Outcome measures
| Measure |
OmegaD
n=150 Eyes
OmegaD Softgels
Omega 3 fatty acid: Omega 3 fatty acid Softgels
|
Placebo
n=159 Eyes
Placebo Softgels
Placebos: Mineral oil Softgels
|
|---|---|---|
|
Tear Osmolarity
|
13.4 mOsm/L
Standard Deviation 17.1
|
11.8 mOsm/L
Standard Deviation 13.2
|
PRIMARY outcome
Timeframe: 84 daysPopulation: Mean change from baseline to Day 84
Mean change from baseline in OSDI to Day 84 in the study eye. One eye (the designated study eye) was was analyzed for each participant. The OSDI is a patient reported outcome measured on a scale from 0 to 100 where higher scores represent greater disability. The overall score is calculated using a chart based on the sum of patient responses to 12 questions each rated on a scale from 0 to 4 where higher scores represent worse outcomes.
Outcome measures
| Measure |
OmegaD
n=151 Eyes
OmegaD Softgels
Omega 3 fatty acid: Omega 3 fatty acid Softgels
|
Placebo
n=162 Eyes
Placebo Softgels
Placebos: Mineral oil Softgels
|
|---|---|---|
|
Ocular Surface Disease Index (OSDI)
|
19.9 score on a scale
Standard Deviation 20.1
|
19.4 score on a scale
Standard Deviation 18.5
|
SECONDARY outcome
Timeframe: 84 daysPopulation: Mean change from baseline to Day 84
Mean change from baseline in TBUT to Day 84 in the study eye. One eye (the designated study eye) was was analyzed for each participant. TBUT is measured as the number of seconds the tear film takes to break up following administration of a drop of fluorescein dye to the eye. Longer times (higher values) represent better outcomes.
Outcome measures
| Measure |
OmegaD
n=150 Eyes
OmegaD Softgels
Omega 3 fatty acid: Omega 3 fatty acid Softgels
|
Placebo
n=159 Eyes
Placebo Softgels
Placebos: Mineral oil Softgels
|
|---|---|---|
|
Tear Break Up Time (TBUT)
|
0.6 Seconds
Standard Deviation 1.7
|
0.6 Seconds
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: 84 daysPopulation: Mean change from baseline to Day 84
Mean change from baseline in Schirmers Test to Day 84 in the study eye. One eye (the designated study eye) was was analyzed for each participant. The test measures the distance in mm that tears travel along the Schirmer test strip (filter strip) after 5 minutes following the placement of the strip in the eye. Higher values represent better outcomes.
Outcome measures
| Measure |
OmegaD
n=150 Eyes
OmegaD Softgels
Omega 3 fatty acid: Omega 3 fatty acid Softgels
|
Placebo
n=159 Eyes
Placebo Softgels
Placebos: Mineral oil Softgels
|
|---|---|---|
|
Schirmers Test
|
1.13 mm
Standard Deviation 6.99
|
0.53 mm
Standard Deviation 6.34
|
Adverse Events
OmegaD
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
OmegaD
n=157 participants at risk
OmegaD Softgels
Omega 3 fatty acid: Omega 3 fatty acid Softgels
|
Placebo
n=165 participants at risk
Placebo Softgels
Placebos: Mineral oil Softgels
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.2%
5/157 • Number of events 5 • 84 days
|
3.6%
6/165 • Number of events 6 • 84 days
|
|
Eye disorders
Conjunctival hyperemia
|
1.9%
3/157 • Number of events 3 • 84 days
|
1.8%
3/165 • Number of events 3 • 84 days
|
|
Gastrointestinal disorders
Diarrhea
|
1.3%
2/157 • Number of events 2 • 84 days
|
1.8%
3/165 • Number of events 3 • 84 days
|
|
Gastrointestinal disorders
Dyspepsia
|
1.9%
3/157 • Number of events 3 • 84 days
|
0.61%
1/165 • Number of events 1 • 84 days
|
|
Gastrointestinal disorders
Gastroenteritis viral
|
0.00%
0/157 • 84 days
|
1.2%
2/165 • Number of events 2 • 84 days
|
|
Infections and infestations
Influenza
|
1.3%
2/157 • Number of events 2 • 84 days
|
0.61%
1/165 • Number of events 1 • 84 days
|
|
Nervous system disorders
Insomnia
|
1.3%
2/157 • Number of events 2 • 84 days
|
0.61%
1/165 • Number of events 1 • 84 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place