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Randomized Controlled Trial
. 2021 Jul 1;40(7):869-876.
doi: 10.1097/ICO.0000000000002580.

Ocular Discomfort and Quality of Life Among Patients in the Dry Eye Assessment and Management Study

Rony R Sayegh  1 , Yinxi Yu  2 , John T Farrar  3 , Eric J Kuklinski  4 , Roni M Shtein  5 , Penny A Asbell  6 , Maureen G Maguire  2 ; Dry Eye Assessment and Management (DREAM) Study Research Group
Affiliations
Randomized Controlled Trial

Ocular Discomfort and Quality of Life Among Patients in the Dry Eye Assessment and Management Study

Rony R Sayegh et al. Cornea. .

Abstract

Purpose: To assess the association of severity of ocular discomfort with measures of quality of life among patients with moderate to severe dry eye disease (DED).

Methods: This is a prospective, observational, cohort study within a randomized clinical trial. Patients (N = 535) in the Dry Eye Assessment and Management study with moderate to severe DED completed the Ocular Surface Disease Index on DED symptoms, the SF-36 on quality of life, and the Brief Ocular Discomfort Inventory questionnaire and had a comprehensive ophthalmic assessment by a study-certified clinician. The ocular discomfort on average over the past week was scored on an 11-point scale (0 for no discomfort and 10 for discomfort as bad as you can imagine).

Results: The average ocular discomfort scores for patients ranged from 0 to 10, with a mean of 4.28. Discomfort scores did not vary with demographic characteristics, signs of DED, self-reported depression, or self-reported nonocular pain conditions. Ocular discomfort scores did correlate moderately to strongly with total Ocular Surface Disease Index scores (Spearman correlation coefficient, rs, 0.47-0.67) and with measures of interference with activities of daily living [general activity level, mood, walking ability, ability for normal work, relations with other people, sleep, and enjoyment of life (rs = 0.39-0.65)].

Conclusions: Among patients in the Dry Eye Assessment and Management study, worse ocular discomfort was associated with worse overall DED symptoms and interfered to a greater degree with activities of daily living. Ocular discomfort is an important part of the assessment of patients with DED.

Trial registration: ClinicalTrials.gov NCT02128763.

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Conflict of interest statement

R. R. Sayegh has received personal fees from Allergan and Novartis. P. A. Asbell has received research grants from the National Eye Institute, MC2 Therapeutics, Miotech, and Regeneron; personal fees from Shire, Medscape, MC2 Therapeutics, Miotech, Bausch & Lomb, ECLA, Astra Zeneca, Topovert, Regeneron, Blephex, Senju, Axero, Eyepoint, Novaliq, Kala, Dompe, Alcon, Allados, Motive, and Sun; and nonfinancial support from ECLA and Regeneron. J. T. Farrar has received research grants and contracts from the US Food and Drug Administration and National Institutes of Health and consulting fees from Analgesic Solutions, Aptinyx, Biogen, Opioid Post-Marketing Consortium, Daiichi Sankyo, DepoMed, Evadera, Jansen, Lilly, Novartis, Vertex, and Pfizer; payment for or data and safety monitoring committee services from NIH-NIA and Cara Therapeutics. M. G. Maguire has received grants from the National Eye Institute and Foundation Fighting Blindness; personal fees from Genentech and Regenera for data and safety monitoring committee services. The remaining authors have no conflicts of interest to disclose.

Figures

Figure 1.
Figure 1.
Mean Ocular Surface Disease Index (OSDI) scores by severity of average ocular discomfort in the last week at baseline and 12 months.
Figure 2
Figure 2
Mean scores for SF-36 summary scores by severity of average ocular discomfort in the last week at baseline and 12 months
Figure 3.
Figure 3.
Mean scores for interference with areas on the Brief Ocular Discomfort Index (BODI) by severity of average ocular discomfort in the last week at baseline and 12 months.
See this image and copyright information in PMC

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