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Dry Eye Assessment and Management (DREAM©) Study: Study design and baseline characteristics.

ABSTRACT: PURPOSE:Describe trial design and baseline characteristics of participants in the DRy Eye Assessment and Management (DREAM©) Study. DESIGN:Prospective, multi-center, randomized, double-masked "real-world" clinical trial assessing efficacy and safety of oral omega-3 (?3) supplementation for the treatment of dry eye disease (DED). METHODS:RESULTS: Mean age of participants was 58.0?±?13.2?years. Mean OSDI score at baseline was 44.4?±?14.2. Mean conjunctival staining score (scale 0-6) was 3.0?±?1.4, corneal staining score (scale 0-15) was 3.9?±?2.7, tear break-up time was 3.1?±?1.5?s, and Schirmer test was 9.6?±?6.5?mm/5?min. CONCLUSIONS:DREAM© participants mirror real world patients who seek intervention for their DED-related symptoms despite their current treatments. Results regarding the efficacy of omega-3 supplementation will be helpful to clinicians and patients with moderate to severe DED who are considering omega-3 as a treatment. This trial design may be a model for future RCT's on nutritional supplements and DED treatments seeking to provide useful information for clinical practice. TRIAL REGISTRATION:ClinicalTrials.gov number NCT02128763.

SUBMITTER: Asbell PA

PROVIDER: S-EPMC7250048 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Dry Eye Assessment and Management (DREAM©) Study: Study design and baseline characteristics.

Asbell Penny A PA Maguire Maureen G MG Peskin Ellen E Bunya Vatinee Y VY Kuklinski Eric J EJ

Contemporary clinical trials 20180606

<h4>Purpose</h4>Describe trial design and baseline characteristics of participants in the DRy Eye Assessment and Management (DREAM©) Study.<h4>Design</h4>Prospective, multi-center, randomized, double-masked "real-world" clinical trial assessing efficacy and safety of oral omega-3 (ω3) supplementation for the treatment of dry eye disease (DED).<h4>Methods</h4>RESULTS: Mean age of participants was 58.0 ± 13.2 years. Mean OSDI score at baseline was 44.4 ± 14.2. Mean conjunctival staining score (sca ...[more]

PMID: 29883769

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Project description:PurposeTo evaluate how increasing age is associated with dry eye disease (DED) signs and symptoms in the Dry Eye Assessment and Management (DREAM) study. This study was undertaken to better understand how DED signs and symptoms differ across decades of life with goals to help assess detection and treatment of DED.DesignSecondary analysis of the DREAM study.SubjectsOne hundred twenty, 140, 185, and 90 participants aged < 50, 50 to 59, 60 to 69, and ≥ 70 years, respectively.MethodsWe performed a secondary analysis of data from the DREAM study, a multicenter randomized clinical trial, to evaluate the effect of omega-3 fatty acid supplementation for the treatment of DED. At baseline, 6 months, and 12 months follow-up, participants underwent an assessment of DED symptoms and signs using Ocular Surface Disease Index, Brief Pain Inventory, tear break-up time (TBUT) (in seconds), Schirmer test with anesthesia (mm/5 minutes), conjunctival staining, corneal staining, meibomian gland dysfunction evaluation, and tear osmolarity (mOsm/l). Multivariable generalized linear regression models were used to compare DED symptoms and signs across the 4 age groups among all participants and by sex.Main outcome measuresScores of DED symptoms, individual signs, and composite scores of DED signs.ResultsAmong 535 patients with DED, increasing age was significantly associated with worse TBUT (P = 0.01), corneal staining (P < 0.001), a composite severity score of DED signs (P = 0.007), and tear osmolarity (P = 0.001). Similar significant differences were found across 4 age groups of 334 women in TBUT, corneal staining score, composite severity score of DED signs, and tear osmolarity (all P < 0.05) but not in men.ConclusionWe found that corneal staining, TBUT, tear osmolarity, and a composite severity score of DED signs were significantly more severe with increasing age in women but not in men; worsening symptoms did not increase with increasing age.Financial disclosuresThe author(s) have no proprietary or commercial interest in any materials discussed in this article.

Dataset Information

Dry Eye Assessment and Management (DREAM©) Study: Study design and baseline characteristics.

Publications

Dry Eye Assessment and Management (DREAM©) Study: Study design and baseline characteristics.

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