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
Last Update Posted : March 23, 2017
|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 ]
- Change from baseline in dry eye symptom scores (OSDI questionnaire) [ Time Frame: Baseline and 84 Days ]
- The proportion of subjects with Meibomian gland dysfunction of grade 0 for both meibomian orifice size and telangiectasia [ Time Frame: 84 Days ]
- The mean change from baseline in tear osmolarity [ Time Frame: Baseline and 84 Days ]
- The mean change from screening in Schirmer's test score at Day 84 [ Time Frame: Baseline and 84 Days ]
- The frequency and severity of adverse events [ Time Frame: 84 Days ]
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|