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. 2018 Aug:71:70-79.
doi: 10.1016/j.cct.2018.06.002. Epub 2018 Jun 6.

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

Penny A Asbell  1 , Maureen G Maguire  2 , Ellen Peskin  2 , Vatinee Y Bunya  2 , Eric J Kuklinski  3 ; Dry Eye Assessment and Management (DREAM©) Study Research Group
Affiliations

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

Penny A Asbell et al. Contemp Clin Trials. 2018 Aug.

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 (ω3) 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.

Keywords: Baseline characteristics; Clinical trial design; Dry eye disease; Inflammation; Nutritional trial design; Omega-3 fatty acid.

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Figures

Fig. 1.
Fig. 1.
CONSORT Diagram for the DRy Eye Assessment and Management (DREAM©) Study.
See this image and copyright information in PMC

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