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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.

Project description:The aim of this research is to initiate a 5-year natural history study of dry eye disease (DED) using objectively assessed and patient-reported outcomes, to explore the hypothesis that DED is a progressive condition that has substantive and measurable impacts not only on the ocular surface, but on quality of life and visual functioning. Our objective for this report is to examine the baseline data.A multicenter, prospective, controlled, observational study of Level 2 (mild-to-moderate) DED patients based on International Task Force Delphi Panel severity grading, and controls, documented baseline measures (including tear film biomarkers and quality of life). Tear cytokine concentrations were also measured in the tear film. Patients were using artificial tears as needed.Two hundred seventeen DED patients and 67 gender- and age-matched controls were enrolled. A majority were females and Caucasian and groups did not differ significantly in terms of gender, race, or age. Differences between DED and matched controls, at baseline, included mean scores for Ocular Surface Disease Index (31.7 vs 4.1, P?<?0.0001), Schirmer test (5.7 vs 15.3 mm, P?<?0.0001), corneal staining (1.4 vs 0.2, P?<?0.0001), conjunctival staining (1.4 vs 0.3, P?<?0.0001), and tear break-up time (5.7 vs 8.5 s, P?<?0.0001). Tear cytokines levels were determined and included interferon-?, interleukin (IL)-1?, IL-2, IL-4, IL-6, IL-8, tumor necrosis factor-?, epidermal growth factor, IL-13, IL-17, IL-1?, and inducible protein-10. The mean levels of IL-8 and IL-6 were slightly higher in the DED group at baseline. Blurred vision was reported as moderate/severe/very severe at baseline in 57.6% of DED patients vs.10.5% of normal controls (P?<?0.0001). DED patients reported greater reductions in work and non-work productivity, as well as greater need for visits to ophthalmologists during the prior year.In this report of the baseline findings of a 5-year natural history study of DED, a striking disease burden is observed with regard to blurred vision, productivity, and visits to eye care practitioners in mild to moderate DED patients compared to normal subjects of similar ages and genders.ClinicalTrials.gov NCT00833235 on January 30, 2009.

Project description:PurposeThe Age-Related Eye Disease Study (AREDS) demonstrated beneficial effects of oral supplementation with antioxidant vitamins and minerals on the development of advanced age-related macular degeneration (AMD) in persons with at least intermediate AMD (bilateral large drusen with or without pigment changes). Observational data suggest that other oral nutrient supplements might further reduce the risk of progression to advanced AMD. The primary purpose of the Age-Related Eye Disease Study 2 (AREDS2) is to evaluate the efficacy and safety of lutein plus zeaxanthin (L+Z) and/or ?-3 long-chain polyunsaturated fatty acid (LCPUFA) supplementation in reducing the risk of developing advanced AMD. The study also assesses the reduction in zinc and the omission of ?-carotene from original AREDS formulation.DesignMulticenter, phase III, randomized, controlled clinical trial.ParticipantsPersons aged 50 to 85 with bilateral intermediate AMD or advanced AMD in 1 eye.MethodsAll participants were randomly assigned to placebo (n = 1012), L+Z (10 mg/2 mg; n = 1044), ?-3 LCPUFAs (eicosapentaenoic acid + docosahexaenoic acid [650 mg/350 mg]; n = 1069), or the combination of L+Z and ?-3 LCPUFAs (n = 1078). All participants were offered a secondary randomization to 1 of 4 variations of the original AREDS formulation keeping vitamins C (500 mg) and E (400 IU) and copper (2 mg) unchanged while varying zinc and ?-carotene as follows: Zinc remains at the original level (80 mg), lower only zinc to 25 mg, omit ?-carotene only, or lower zinc to 25 mg and omit ?-carotene.Main outcome measuresProgression to advanced AMD determined by centralized grading of annual fundus photographs.ResultsWe enrolled 4203 participants at 82 clinical centers located in the United States. Population characteristics at baseline were as follows: Mean age, 74 years; 57% female; 97% white; 7% current smokers; 19% with prior cardiovascular disease; and 44% and 50% taking statin-class cholesterol-lowering drugs and aspirin, respectively. Ocular characteristics include 59% with bilateral large drusen, 32% with advanced AMD in 1 eye and mean visual acuity of 20/32 in eyes without advanced AMD.ConclusionsThis report presents the AREDS2 study design and the participants' baseline demographic and ocular characteristics.

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

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

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