Trial Outcomes & Findings for Oral Omega-3 Fatty Acids in the Treatment of Dry Eye Syndrome (NCT NCT01107964)

Results Overview

The Ocular Surface Disease Index Score is a validated, scored questionnaire that measures subjective symptoms of dry eye. Possible scores range from 0 (no symptoms of dry eye) to 100 (severest symptoms of dry eye). Change = (Day 45 score - Baseline score)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

27 participants

Primary outcome timeframe

Baseline and Day 45

Results posted on

2017-12-22

Participant Flow

Participant milestones

Participant milestones
Measure	Omega-3-acid Ethyl Esters Oral Omega-3-acid ethyl esters: 1 gram capsule by mouth four times daily for 45 days	Corn Oil Capsule Placebo corn oil capsule: 1 gram by mouth 4 times daily for 45 days
Overall Study STARTED	13	14
Overall Study COMPLETED	12	13
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oral Omega-3 Fatty Acids in the Treatment of Dry Eye Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Omega-3-acid Ethyl Esters n=13 Participants Oral Omega-3-acid ethyl esters: 1 gram capsule by mouth four times daily for 45 days	Corn Oil Capsule n=14 Participants Placebo corn oil capsule: 1 gram by mouth 4 times daily for 45 days	Total n=27 Participants Total of all reporting groups
Age, Continuous	54 years n=5 Participants	60 years n=7 Participants	58 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Day 45

Population: Throughout the study, we evaluated the worse eye of each patient, defined as the eye with the the higher Lissamine Green Staining Score or the eye with the lower Schirmer-1 Test Value in the event of equality.

The Ocular Surface Disease Index Score is a validated, scored questionnaire that measures subjective symptoms of dry eye. Possible scores range from 0 (no symptoms of dry eye) to 100 (severest symptoms of dry eye). Change = (Day 45 score - Baseline score)

Outcome measures

Outcome measures
Measure	Omega-3-acid Ethyl Esters n=12 eyes Oral Omega-3-acid ethyl esters: 1 gram capsule by mouth four times daily for 45 days	Corn Oil Capsule n=13 eyes Placebo corn oil capsule: 1 gram by mouth 4 times daily for 45 days
Change From Baseline of the Ocular Surface Disease Index Score at Day 45	-28.4 units on a scale Interval -36.4 to -11.8	-5.8 units on a scale Interval -39.6 to 1.3

SECONDARY outcome

Timeframe: Baseline and Day 45

Population: Throughout the study, we evaluated the worse eye of each patient, defined as the eye with the the higher Lissamine Green Staining Score or the eye with the lower Schirmer-1 Test Value in the event of equality.

Schirmer-1 Test Value is a measurement of tear production. The amount of tears are measured in total millimeters after 5 minutes has elapsed. Low levels of tear production are associated with dry eye. Change = (Day 45 value - Baseline value).

Outcome measures

Outcome measures
Measure	Omega-3-acid Ethyl Esters n=12 eyes Oral Omega-3-acid ethyl esters: 1 gram capsule by mouth four times daily for 45 days	Corn Oil Capsule n=13 eyes Placebo corn oil capsule: 1 gram by mouth 4 times daily for 45 days
Change From Baseline of Schirmer-1 Test Value at Day 45	-2.5 millimeters Interval -3.0 to 1.0	1.0 millimeters Interval -4.0 to 4.0

SECONDARY outcome

Timeframe: Baseline and Day 45

Population: Throughout the study, we evaluated the worse eye of each patient, defined as the eye with the the higher Lissamine Green Staining Score or the eye with the lower Schirmer-1 Test Value in the event of equality.

Lissamine Green Staining Score is a measure of ocular surface irregularity secondary to dry eye. Possible scores range from 0 (no ocular surface irregularity secondary to dry eye) to 9 (severe ocular surface irregularity secondary to dry eye). Change = (Day 45 score - Baseline score)

Outcome measures

Outcome measures
Measure	Omega-3-acid Ethyl Esters n=12 eyes Oral Omega-3-acid ethyl esters: 1 gram capsule by mouth four times daily for 45 days	Corn Oil Capsule n=13 eyes Placebo corn oil capsule: 1 gram by mouth 4 times daily for 45 days
Change From Baseline of Lissamine Green Staining Score at Day 45	1.0 units on a scale Interval -1.5 to 1.0	-1.0 units on a scale Interval -2.0 to 0.0

SECONDARY outcome

Timeframe: Baseline and Day 45

Population: Throughout the study, we evaluated the worse eye of each patient, defined as the eye with the the higher Lissamine Green Staining Score or the eye with the lower Schirmer-1 Test Value in the event of equality.

Fluorescein Tear Break-Up Time is a measurement in seconds of tear film stability. The shorter the Fluorescein Tear Break-Up Time, the lower the tear film stability. Lower tear film stability is associated with dry eye. Change = (Day 45 value - Baseline value).

Outcome measures

Outcome measures
Measure	Omega-3-acid Ethyl Esters n=12 eyes Oral Omega-3-acid ethyl esters: 1 gram capsule by mouth four times daily for 45 days	Corn Oil Capsule n=13 eyes Placebo corn oil capsule: 1 gram by mouth 4 times daily for 45 days
Change From Baseline of Fluorescein Tear Break-Up Time (Seconds) at Day 45	1.7 time in seconds Interval 0.3 to 3.8	0.3 time in seconds Interval -0.7 to 4.3

Adverse Events

Omega-3-acid Ethyl Esters

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Corn Oil Capsule

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Omega-3-acid Ethyl Esters n=13 participants at risk Oral Omega-3-acid ethyl esters: 1 gram capsule by mouth four times daily for 45 days	Corn Oil Capsule n=14 participants at risk Placebo corn oil capsule: 1 gram by mouth 4 times daily for 45 days
Reproductive system and breast disorders Breast tenderness	7.7% 1/13 • Number of events 1 • Adverse event data were collected for the entire duration of the 45 day trial.	0.00% 0/14 • Adverse event data were collected for the entire duration of the 45 day trial.
Gastrointestinal disorders Dyspepsia	0.00% 0/13 • Adverse event data were collected for the entire duration of the 45 day trial.	7.1% 1/14 • Number of events 1 • Adverse event data were collected for the entire duration of the 45 day trial.
Gastrointestinal disorders Diarrhea	7.7% 1/13 • Number of events 1 • Adverse event data were collected for the entire duration of the 45 day trial.	0.00% 0/14 • Adverse event data were collected for the entire duration of the 45 day trial.

Additional Information

Dr. David Liang

Milton S. Hershey Medical Center

Phone: 717-497-9469

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place