Trial Outcomes & Findings for Study of the Safety and Efficacy of OmegaD Softgels in the Treatment of Dry Eye Disease (NCT NCT02980224)

Last Updated: 2019-12-13

Results Overview

The difference between Baseline (Day 1) and Day 84 in Tear Break Up Time. TBUT is a clinical test used to assess for evaporative dry eye disease. To measure TBUT, fluorescein is instilled into the patient's tear film and the patient is asked not to blink while the tear film is observed under a broad beam of cobalt blue illumination. The TBUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film, as observed via slit lamp examination.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

180 participants

Primary outcome timeframe

Baseline and 84 Days

Results posted on

2019-12-13

Participant Flow

Participant milestones

Participant milestones
Measure	OmegaD OmegaD Softgels OmegaD: OmegaD Softgels	Placebo Placebo Softgels Placebo: Placebo Softgels
Overall Study STARTED	89	91
Overall Study COMPLETED	85	88
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	OmegaD OmegaD Softgels OmegaD: OmegaD Softgels	Placebo Placebo Softgels Placebo: Placebo Softgels
Overall Study Adverse Event	4	1
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

Study of the Safety and Efficacy of OmegaD Softgels in the Treatment of Dry Eye Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OmegaD n=89 Participants OmegaD Softgels OmegaD: OmegaD Softgels	Placebo n=91 Participants Placebo Softgels Placebo: Placebo Softgels	Total n=180 Participants Total of all reporting groups
Age, Continuous	59.6 years STANDARD_DEVIATION 12.78 • n=93 Participants	61.5 years STANDARD_DEVIATION 12.53 • n=4 Participants	60.6 years STANDARD_DEVIATION 12.66 • n=27 Participants
Sex: Female, Male Female	78 Participants n=93 Participants	71 Participants n=4 Participants	149 Participants n=27 Participants
Sex: Female, Male Male	11 Participants n=93 Participants	20 Participants n=4 Participants	31 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	29 Participants n=93 Participants	23 Participants n=4 Participants	52 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	60 Participants n=93 Participants	68 Participants n=4 Participants	128 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	3 Participants n=93 Participants	5 Participants n=4 Participants	8 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	7 Participants n=93 Participants	4 Participants n=4 Participants	11 Participants n=27 Participants
Race (NIH/OMB) White	79 Participants n=93 Participants	82 Participants n=4 Participants	161 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	89 Participants n=93 Participants	91 Participants n=4 Participants	180 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and 84 Days

Population: Intent to Treat Population

Outcome measures

Outcome measures
Measure	OmegaD n=89 Participants OmegaD Softgels OmegaD: OmegaD Softgels	Placebo n=91 Participants Placebo Softgels Placebo: Placebo Softgels
Change From Baseline in Tear Break up Time(TBUT ) at Day 84	1.45 seconds Standard Error 0.261	1.23 seconds Standard Error 0.260

PRIMARY outcome

Timeframe: Baseline and 84 Days

Population: Intent to Treat Population

Difference from Baseline (Day 1) to Day 84 in the OSDI Questionnaire (dry eye symptom score). Responses evaluate a subjects experience of a symptom on the following scale: 0 (none of the time) 1. (some of the time) 2. (half of the time) 3. (most of the time) 4. (all of the time) The 12 questions are as follows: Have you experienced any of the following during the last week: 1. Eyes that are sensitive to light 2. Eyes that feel gritty 3. Painful or sore eyes 4. Blurred vision 5. Poor vision Have problems with your eyes limited you in performance of any of the following during the last week: 6. Reading 7. Driving at night 8. Working with a computer or bank machine (ATM) 9. Watching TV Have your eyes felt uncomfortable in any of the following situations during the last week: 10. Windy conditions 11. Places or areas with low humidity (very dry) 12. Areas that are air conditioned A higher score means a worse outcome. The scores for the 12 questions are added together.

Outcome measures

Outcome measures
Measure	OmegaD n=89 Participants OmegaD Softgels OmegaD: OmegaD Softgels	Placebo n=91 Participants Placebo Softgels Placebo: Placebo Softgels
Change From Baseline in Dry Eye Symptom Scores (OSDI Questionnaire)	-13.39 score on a scale Standard Error 1.804	-15.04 score on a scale Standard Error 1.794

SECONDARY outcome

Timeframe: 84 Days

Population: Safety Population

Number and Percentage of Subjects Reporting Adverse Events

Outcome measures

Outcome measures
Measure	OmegaD n=89 Participants OmegaD Softgels OmegaD: OmegaD Softgels	Placebo n=91 Participants Placebo Softgels Placebo: Placebo Softgels
The Frequency and Severity of Adverse Events Number of Subjects Reporting AEs	23 Participants	16 Participants
The Frequency and Severity of Adverse Events Number of Subjects Reporting 1 AE	17 Participants	9 Participants
The Frequency and Severity of Adverse Events Number of Subjects Reporting >1 AE	6 Participants	7 Participants
The Frequency and Severity of Adverse Events Number of Serious AEs	0 Participants	0 Participants
The Frequency and Severity of Adverse Events Subjects Reporting AEs leading to Discontinuation	4 Participants	1 Participants
The Frequency and Severity of Adverse Events Subjects with AEs leading to Drug Interrupti	1 Participants	0 Participants
The Frequency and Severity of Adverse Events Deaths	0 Participants	0 Participants
The Frequency and Severity of Adverse Events Number of Subjects Reporting 0 AEs	66 Participants	75 Participants

Adverse Events

OmegaD

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo

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	OmegaD n=89 participants at risk OmegaD Softgels OmegaD: OmegaD Softgels	Placebo n=91 participants at risk Placebo Softgels Placebo: Placebo Softgels
Gastrointestinal disorders Diarrhoea	4.5% 4/89 • Number of events 4 • 84 Days	0.00% 0/91 • 84 Days
Gastrointestinal disorders Abdominal discomfort	2.2% 2/89 • Number of events 2 • 84 Days	0.00% 0/91 • 84 Days
Gastrointestinal disorders Abdominal Pain	2.2% 2/89 • Number of events 2 • 84 Days	0.00% 0/91 • 84 Days
Infections and infestations Upper Respiratory Tract Infection	4.5% 4/89 • Number of events 4 • 84 Days	1.1% 1/91 • Number of events 1 • 84 Days

Additional Information

Jeremy Brace, President

Brace Consulting Group Inc.

Phone: 7274582823

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER