September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Baseline Characteristics in the Dry Eye Assessment and Management (DREAM) Study
Author Affiliations & Notes
  • Milton M Hom
    Optometry, Private Practice, Azusa, California, United States
  • Footnotes
    Commercial Relationships   Milton Hom, Allergan (F), AMO (F), Bausch and Lomb (F), OptoVue (C), Shire (C)
  • Footnotes
    Support  NIH Grants U10 EY022881 and U10 EY022879
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 2844. doi:
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      Milton M Hom; Baseline Characteristics in the Dry Eye Assessment and Management (DREAM) Study. Invest. Ophthalmol. Vis. Sci. 2016;57(12):2844.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : To describe the DREAM study population as defined by eligibility criteria intended to identify patients with moderate to severe dry eye disease (DED). DREAM is a multicenter clinical trial to evaluate oral omega-3 fatty acid supplementation for DED.

Methods : Candidates are evaluated for eligibility at a Screening Visit and, approximately 2 weeks later, a Baseline visit by study certified clinicians and staff at more than 20 clinical centers throughout the United States. To qualify for the study, adult patients must have an Ocular Surface Disease Index (OSDI) score of 25-80 at Screening and 21-80 at Baseline, have symptoms of DED for at least 6 months, and use or desire to use artificial tears at least 2 times a day. In addition, at least one eye of the patient must have 2 reproducible signs of DED defined as 1) Conjunctival lissamine green staining score ≥1 out of a highest possible score of 6; 2) corneal fluorescein staining score ≥4 out of 15; Tear break-up time ≤7 seconds, and Schirmer test (with anesthesia) ≥1 and ≤7mm/5 minutes. Patients using other DED treatments are eligible if they commit to continuing those treatments throughout the study.

Results : Among the first 265 patients enrolled, the mean (standard deviation - SD) age was 57.8 (13.5) years, 219 (83%) were female, 50 (19%) Hispanic, 183 (59%) White, 26 (10%) Black, 11 (4%), Asian, and 242 (91%) had both eyes qualify. OSDI total scores were distributed over the entire allowable range with a mean (SD) of 46.5 (15.4) at Screening and 41.9 (15.6) at Baseline (Table 1). The mean score for the 3 OSDI subscales differed: 52.4 for environmental triggers, 44.7 for vision-related function, and 30.0 for ocular symptoms (p<0.001). The mean score for signs was similar at Baseline and Screening visits. The mean (SD) score at the Baseline visit was 3.2 (1.6) for conjunctival staining, 3.9 (3.2) for corneal staining, 3.1 (1.7) for tear break-up time, and 9.4 (7.1) for Schirmer test. Aside from artificial tears, 92 (35%) used cyclosporine drops, 55 (21%) used warm lid soaks, 33 (12%) used lubricating ointment, 27 (10%) used lid scrubs, and 22(8%) had punctal plugs.

Conclusions : Despite use of a variety of common treatments for DED by DREAM participants, the mean baseline OSDI score remained in the severe range.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

 

Table 1: OSDI scores at baseline/screening visits.

Table 1: OSDI scores at baseline/screening visits.

 

Table 2: Staining, tear break-up time and Schirmer scores at baseline/screening visits.

Table 2: Staining, tear break-up time and Schirmer scores at baseline/screening visits.

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