Study of the Safety and Efficacy of OmegaD Softgels in the Treatment of Dry Eye Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02980224|
Recruitment Status : Completed
First Posted : December 2, 2016
Results First Posted : September 11, 2019
Last Update Posted : December 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye||Drug: OmegaD Drug: Placebo||Phase 3|
Inflammation is a key component of dry eye disease. Increasing the systemic levels of omega-3 fatty acids relative to omega-6 levels can mediate immune responses. Evaluating whether omega-3 supplementation can improve dry eye disease signs, symptoms and associated measures of inflammation may present a new therapeutic option for dry eye disease.
The primary objective of this study is to evaluate the safety and efficacy of twice daily (BID) dosing of OmegaD softgels in subjects with dry eye disease.
Male and female subjects between 18 years and 90 years of age, with patient-reported dry eye symptoms and a clinical diagnosis of dry eye disease supported by global clinical assessment will be screened and enrolled. Each subject must have, in at least one eye, tear osmolarity of ≥ 312 mOsm/L and meibomian gland dysfunction as defined by a grade of 1 or 2 on the meibomian orifice size scale at both Screening and Baseline in at least one eye. In addition, Tear break up time (TBUT) must be ≤ 7 seconds in both eyes at both Screening and Baseline and the Schirmer's test score in both eye(s) must be ≥ 5 mm at Baseline.
Approximately 164 subjects will be randomized (1:1) to 1 of 2 treatment arms and treated for 84 days (12 weeks) with either OmegaD softgels; 2 softgels BID or placebo softgels; 2 softgels BID. The study will be double-masked with OmegaD and placebo being identical-appearing softgels.
Subjects will participate in safety and efficacy assessments throughout the study. Efficacy assessments will include, tear osmolarity, meibomian gland dysfunction grading, TBUT, Schirmer's Test, and dry eye symptoms based on the OSDI questionnaire, Safety assessments will include, slit lamp examination and adverse events.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Multicenter, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of OmegaD Softgels in the Treatment of Dry Eye Disease|
|Actual Study Start Date :||October 2016|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||February 2017|
Placebo Comparator: Placebo
- Change From Baseline in Tear Break up Time(TBUT ) at Day 84 [ Time Frame: Baseline and 84 Days ]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.
- Change From Baseline in Dry Eye Symptom Scores (OSDI Questionnaire) [ Time Frame: Baseline and 84 Days ]
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)
- (some of the time)
- (half of the time)
- (most of the time)
- (all of the time)
The 12 questions are as follows:
Have you experienced any of the following during the last week:
- Eyes that are sensitive to light
- Eyes that feel gritty
- Painful or sore eyes
- Blurred vision
Have problems with your eyes limited you in performance of any of the following during the last week:
- Driving at night
- Working with a computer or bank machine (ATM)
Have your eyes felt uncomfortable in any of the following situations during the last week:
- Windy conditions
- Places or areas with low humidity (very dry)
- Areas that are air conditioned
A higher score means a worse outcome. The scores for the 12 questions are added together.
- The Frequency and Severity of Adverse Events [ Time Frame: 84 Days ]Number and Percentage of Subjects Reporting Adverse Events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980224
|United States, California|
|Artesia, California, United States|
|Mission Hills, California, United States|
|Rancho Cordova, California, United States|
|United States, Connecticut|
|Danbury, Connecticut, United States|
|United States, Florida|
|Crystal River, Florida, United States|
|Deerfield Beach, Florida, United States|
|Fort Myers, Florida, United States|
|United States, Kansas|
|Pittsburg, Kansas, United States|
|United States, Kentucky|
|Edgewood, Kentucky, United States|
|United States, Ohio|
|Cincinnati, Ohio, United States|
|Cleveland, Ohio, United States|