Trial Outcomes & Findings for Dry Eye Assessment and Management: Feasibility Study (NCT NCT01102257)

NCT ID: NCT01102257

Last Updated: 2012-08-23

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 23 participants
• Primary outcome timeframe: 90 +/- 14 days following initiation of drug regimen
• Results posted on: 2012-08-23

Participant Flow

Participant milestones

Measure	Omega-3 Supplement 5 Gel Capsules to be taken orally daily to give a total dose of 2000mg EPA and 1000 mg DHA	Olive Oil 5 Gel Capsules of olive oil to be taken orally daily
Overall Study STARTED	9	9
Overall Study COMPLETED	7	9
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Omega-3 Supplement 5 Gel Capsules to be taken orally daily to give a total dose of 2000mg EPA and 1000 mg DHA	Olive Oil 5 Gel Capsules of olive oil to be taken orally daily
Overall Study Adverse Event	1	0

Baseline Characteristics

Dry Eye Assessment and Management: Feasibility Study

Baseline characteristics by cohort

Measure	Omega-3 Supplement n=9 Participants 5 Gel Capsules taken orally to achieve a daily dose of 2000mg EPA and 1000mg DHA	Olive Oil n=9 Participants 5 Gel Capsules of olive oil taken orally daily	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Age Continuous	55 years STANDARD_DEVIATION 14 • n=5 Participants	57 years STANDARD_DEVIATION 15 • n=7 Participants	56 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	9 participants n=7 Participants	18 participants n=5 Participants

PRIMARY outcome

Timeframe: 90 +/- 14 days following initiation of drug regimen

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline and 3 Months

Outcome measures

Measure	Omega-3 Supplement n=7 Participants 5 Gel Capsules taken orally to achieve a daily dose of 2000mg EPA and 1000mg DHA	Olive Oil n=9 Participants 5 Gel Capsules of olive oil taken orally daily
Change in REd Blood Cell(RBC) Membrane Fatty Acid(FA) Content eicosapentaenoic acid(EPA)	1.46 Percentage Total Fatty Acids Interval 0.23 to 2.39	0.05 Percentage Total Fatty Acids Interval -0.01 to 0.09
Change in REd Blood Cell(RBC) Membrane Fatty Acid(FA) Content docosahexaenoic acid(DHA)	1.49 Percentage Total Fatty Acids Interval -0.36 to 1.9	0.25 Percentage Total Fatty Acids Interval -0.2 to 0.36
Change in REd Blood Cell(RBC) Membrane Fatty Acid(FA) Content Arachdinocic acid(AA)	-1.91 Percentage Total Fatty Acids Interval -3.17 to -0.97	-0.23 Percentage Total Fatty Acids Interval -0.84 to -0.05

SECONDARY outcome

Timeframe: 90 +/- 14 days following initiation of drug regimen

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 90 +/- 14 days following initiation of drug regimen

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 90 +/- 14 days following initiation of drug regimen

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 90 +/- 14 days following initiation of drug regimen

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 90 +/- 14 days following initiation of drug regimen

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 90 +/- 14 days following initiation of drug regimen

Outcome measures

Outcome data not reported

Adverse Events

Omega-3 Supplement

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Olive Oil

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Omega-3 Supplement n=4 participants at risk；n=9 participants at risk 5 Gel Capsules taken orally to achieve a daily dose of 2000mg EPA and 1000mg DHA	Olive Oil n=2 participants at risk；n=9 participants at risk 5 Gel Capsules of olive oil taken orally daily
Nervous system disorders Migraine	0.00% 0/9 • 6 months	11.1% 1/9 • Number of events 1 • 6 months
Respiratory, thoracic and mediastinal disorders Shortness of Breath	11.1% 1/9 • Number of events 1 • 6 months	0.00% 0/9 • 6 months
Immune system disorders Adnexal mass due to graft verus host disease	11.1% 1/9 • Number of events 1 • 6 months	0.00% 0/9 • 6 months

Other adverse events

Measure	Omega-3 Supplement n=4 participants at risk；n=9 participants at risk 5 Gel Capsules taken orally to achieve a daily dose of 2000mg EPA and 1000mg DHA	Olive Oil n=2 participants at risk；n=9 participants at risk 5 Gel Capsules of olive oil taken orally daily
Eye disorders watery eyes	100.0% 1/1 • Number of events 1 • 6 months	100.0% 1/1 • Number of events 1 • 6 months
Nervous system disorders thirst	100.0% 1/1 • Number of events 1 • 6 months	100.0% 1/1 • Number of events 1 • 6 months
Nervous system disorders nausea	100.0% 2/2 • Number of events 2 • 6 months	— 0/0 • 6 months

Additional Information

Dr. Penny Asbell

Mount Sinai School of Medicine

Phone: (212) 241-7977

Email: penny.asbell@mssm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place