Trial Outcomes & Findings for The Effects of Dietary Supplementation With Omega-3 Fatty Acids on Symptoms of Dry Eye (NCT NCT03141931)

NCT ID: NCT03141931

Last Updated: 2020-06-11

Results Overview

Measured using the Ocular Surface Disease Index questionnaire. Ocular surface disease index is assessed on a scale of 0 to 100 with higher score representing greater disability. Scores can range from 10 to 100.

Recruitment status

COMPLETED

Study phase

Target enrollment

119 participants

Primary outcome timeframe

3 months

Results posted on

2020-06-11

Participant Flow

Participant milestones

Participant milestones
Measure	Lacritec Combination of flaxseed oil, borage oil and fish oil omega-3 fatty acids Lacritec: Concentrated Omega-3 Triglycerides-fish 332 mg Equiv. Eicosapentaenoic Acid (EPA) 134 mg Equiv. Docosahexaenoic Acid (DHA) 66.8 mg Flax Seed Oil (Linseed Oil) 334 mg Equiv. Oleic acid 58.5 mg Equiv. Linoleic acid 58.5 mg Equiv. Linolenic acid 192 mg Borago officinalis seed oil fixed (Borage) 434 mg Equiv. gamma-Linolenic acid 95.5 mg	Placebo Polyethylene glycol, Oleic acid, Propylene glycol Placebo: polyethylene glycol (500mg), oleic acid (659mg) and propylene glycol (115mg)
Overall Study STARTED	61	58
Overall Study COMPLETED	49	52
Overall Study NOT COMPLETED	12	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effects of Dietary Supplementation With Omega-3 Fatty Acids on Symptoms of Dry Eye

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Supplement n=61 Participants Combination of flaxseed oil, borage oil and fish oil omega-3 fatty acids Lacritec: Concentrated Omega-3 Triglycerides-fish 332 mg Equiv. Eicosapentaenoic Acid (EPA) 134 mg Equiv. Docosahexaenoic Acid (DHA) 66.8 mg Flax Seed Oil (Linseed Oil) 334 mg Equiv. Oleic acid 58.5 mg Equiv. Linoleic acid 58.5 mg Equiv. Linolenic acid 192 mg Borago officinalis seed oil fixed (Borage) 434 mg Equiv. gamma-Linolenic acid 95.5 mg	Placebo n=58 Participants Polyethylene glycol, Oleic acid, Propylene glycol Placebo: polyethylene glycol (500mg), oleic acid (659mg) and propylene glycol (115mg)	Total n=119 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	49 Participants n=5 Participants	42 Participants n=7 Participants	91 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Age, Continuous	38.9 years STANDARD_DEVIATION 18.2 • n=5 Participants	44.1 years STANDARD_DEVIATION 19.2 • n=7 Participants	41.43 years STANDARD_DEVIATION 18.83 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	37 Participants n=7 Participants	81 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	21 Participants n=7 Participants	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	61 Participants n=5 Participants	58 Participants n=7 Participants	119 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	35 Participants n=5 Participants	25 Participants n=7 Participants	60 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	33 Participants n=7 Participants	59 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Australia	61 Participants n=5 Participants	58 Participants n=7 Participants	119 Participants n=5 Participants
Ocular Surface Disease Index	37 units on a scale n=5 Participants	36 units on a scale n=7 Participants	36 units on a scale n=5 Participants
Ocular Comfort Index	40.6 units on a scale n=5 Participants	38.9 units on a scale n=7 Participants	39.0 units on a scale n=5 Participants
Dry Eye Questionnaire - 5	12.43 units on a scale n=5 Participants	11.5 units on a scale n=7 Participants	11.80 units on a scale n=5 Participants
Non-invasive tear break-up time	11.7 seconds STANDARD_DEVIATION 5.1 • n=5 Participants	12.0 seconds STANDARD_DEVIATION 6.4 • n=7 Participants	11.70 seconds STANDARD_DEVIATION 6.28 • n=5 Participants
Tear Evaporation	58.03 g.m^2.h n=5 Participants	58.36 g.m^2.h n=7 Participants	58.24 g.m^2.h n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: All participant received at-least one dose of treatment.