Phase 3 N=535 Randomized Quadruple-blind Treatment

Dry Eye Assessment and Management Study

Dry Eye

Bottom Line

View on ClinicalTrials.gov: NCT02128763 ↗

Enrolled (actual)

535

Serious AEs

6.7%

Results posted

Jan 2019

Primary outcome: Primary: Mean of Change From Baseline in Ocular Surface Disease Index (OSDI) Score at 6 and 12 Months — -13.9; -12.5 units on a scale — p=0.40

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Omega-3 supplements (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Pennsylvania
Primary completion: Sep 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean of Change From Baseline in Ocular Surface Disease Index (OSDI) Score at 6 and 12 Months	-13.9; -12.5	0.40
SECONDARY Greater Than or Equal to 10 Point Decrease in Ocular Surface Disease Index (OSDI) (at Least 10 Point Improvement in Symptoms)	202; 91	0.09
SECONDARY Change in Brief Ocular Discomfort Index (BODI) Pain Interference Subscale	-9.4; -8.9	0.77
SECONDARY Change From Baseline in SF-36 Physical Health Subscale	0.1; 0.1	0.95
SECONDARY Change From Baseline in SF-36 Mental Health Subscale	-0.9; 0.4	0.051
SECONDARY Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of EPA	2.2; 0.0	<0.001 sig
SECONDARY Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of DHA	1.6; 0.0	<0.001 sig
SECONDARY Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of Oleic Acid	-0.1; -0.1	0.40
SECONDARY Change in Conjunctival Staining Score	-0.4; -0.4	0.77
SECONDARY Change in Schirmer's Test mm	0.4; 0.3	0.95
SECONDARY Change in Tear Film Break up Time, in Seconds	0.7; 0.6	0.25
SECONDARY Change in Corneal Fluorescein Staining Score	-0.6; -0.7	0.61
SECONDARY Change in Visual Acuity	-0.5; -0.2	0.42
SECONDARY Change in Use of Artificial Tears and Other Treatments for Dry Eye Disease	171; 93; 80; 36; 40; 23	0.60

Summary

The objective of the DREAM study is to evaluate the effectiveness and safety of supplementation with omega-3 fatty acids in relieving the symptoms of moderate to severe dry eye disease.

Eligibility Criteria

Inclusion Criteria

Greater than or equal to 2 of the following 4 signs in the same eye at screening and baseline visits (Same signs must be present at Screening and Baseline visits): Conjunctival staining present greater than or equal to 1 (out of possible score of 6 per eye), Corneal fluorescein staining present greater than or equal to 4 (out of a possible score of 15 per eye), Tear film break up time (TBUT) less than or equal to 7 seconds, Schirmer's test greater than or equal to 1 to less than or equal to 7 mm in 5 minutes.
Ocular Surface Disease Index (OSDI) score: 25-80 at screening, 21-80 at baseline.
Symptoms of DED for greater than or equal to 6 months.
Use of or desire to use artificial tears at least 2 times per day in preceding 2 weeks.
Ability to swallow large, soft gelcaps

Exclusion Criteria

Allergic to ingredients in supplements or placebo
Contact lens wear
Pregnant, nursing, or lactating
Current ocular infection, inflammation, or acute allergic conjunctivitis
History of: ocular herpetic keratitis, ocular surgery in past 6 months, LASIK surgery, use of glaucoma medicine or surgery for glaucoma, liver disease, atrial fibrillation, hemophilia or bleeding tendencies
Currently on anticoagulation therapy
Eyelid abnormalities or extensive ocular scarring
Use of EPA/DHA supplements in excess of 1200 mg per dayi
Current use, insufficient washout period, or intent to change specific treatments for dry eye disease

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02128763). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.