Dataset Information

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

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.

SUBMITTER: Sayegh RR

PROVIDER: S-EPMC8175479 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature

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Publications

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

Sayegh Rony R RR Yu Yinxi Y Farrar John T JT Kuklinski Eric J EJ Shtein Roni M RM Asbell Penny A PA Maguire Maureen G MG

Cornea 20210701 7

<h4>Purpose</h4>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).<h4>Methods</h4>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 qu ...[more]

PMID: 33290317

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Project description:BackgroundPhysical cooling of the eye surface relieves ocular discomfort, but translating this event to drug treatment of dry eye discomfort not been studied. Here, we synthesized a water-soluble TRPM8 receptor agonist called cryosim-3 (C3, 1-diisopropylphosphorylnonane) which selectively activates TRPM8 (linked to cooling) but not TRPV1 or TRPA1 (linked to nociception) and tested C3 in subjects with mild forms of dry eye disease.MethodsA set of 1-dialkylphosphoryalkanes were tested for activation of TRPM8, TRPV1 and TRPA1 receptors in transfected cells. The bioactivity profiles were compared by perioral, topical, and intravenous delivery to anesthetized rats. The selected lead candidate C3 or vehicle (water) was applied with a cotton gauze pad to upper eyelids of patients with dry eye disease (n = 30). Cooling sensation, tear film break-up time (TBUT), basal tear secretion, and corneal staining were evaluated. C3 was then applied four times daily for 2 weeks to patients using a pre-loaded single unit applicator containing 2 mg/mL of C3 in water (n = 20) or water only. TBUT, basal tear secretion, and corneal staining, and three questionnaires surveys of ocular discomfort (VAS scale, OSDI, and CVS symptoms) were analyzed before and at 1 and 2 weeks thereafter.ResultsC3 was a selective and potent TRPM8 agonist without TRPV1 or TRPA1 activity. In test animals, the absence of shaking behavior after C3 perioral administration made it the first choice for further study. C3 increased tear secretion in an animal model of dry eye disease and did not irritate when wiped on eyes of volunteers. C3 singly applied (2 mg/ml) produced significant cooling in <5 min, an effecting lasting 46 min with an increase in tear secretion for 60 min. C3 applied for 2 weeks also significantly increased basal tear secretion with questionnaire surveys of ocular discomfort indices clearly showing improvement of symptoms at 1 and 2 weeks. No complaints of irritation or pain were reported by any subject.ConclusionsC3 is a promising candidate for study of TRPM8 function on the eye surface and for relief of dry eye discomfort.Trial registrationISRCTN24802609 and ISRCTN13359367 . Registered 23 March 2015 and 2 September 2015.

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Dataset Information

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

Purpose

Methods

Results

Conclusions

Publications

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

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