DRy Eye Outcome and Prescription Study (DROPS)

Dry Eye Outcome and Prescription Study

The DRy eye Outcome and Prescription Study (DROPS) is a large observational multicentre study exploring the 'real world' effectiveness of artificial tears in dry eye disease and determinants of efficacy. The aim is to include at least 635 symptomatic dry eye patients who are prescribed artificial tears. All trainees and fellows in London are invited to become collaborators: collaborators are asked to consent patients, assess signs at baseline, and give patients questionnaires at baseline and 4 weeks (for home completion). In tandem, we are conducting a qualitative review of ophthalmologists' prescribing behaviours for dry eye disease.

Study Overview

• Status: Unknown
• Conditions: Eye Diseases; Dry Eye; Eye Pain; Meibomian Gland Dysfunction; Dry Eye Syndrome; Blepharitis; Tear Film Insufficiency; Kerato Conjunctivitis Sicca; Punctate Epithelial Keratitis; Punctate Keratitis
• Intervention / Treatment: Device: Artificial tears (classified by MHRA as a medical device)

• Study Type: Observational
• Enrollment (Anticipated): 635

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • Guys and St Thomas's Hospital
    • Contact: Jelle Vehof; Phone Number: 02071889055; Email: maria.bell@kcl.ac.uk
    • Contact: Phone Number: 02071889055; Email: maria.bell@kcl.ac.uk
  • London, United Kingdom
    • Recruiting
    • Guys and St Thomas' Hospital
    • Contact: Chris Hammond; Phone Number: 02071889055; Email: maria.bell@kcl.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients attending hospital ophthalmology outpatient clinics and emergency care (Eye Casualty). Dry eye can be the presenting problem or a secondary problem.

Description

Inclusion Criteria:

• adult patients (18 years and over) with symptoms* of dry eye disease (with or without signs, with or without blepharitis) who start one or more artificial tears. *Symptoms of dry eye disease include: foreign body sensation, dryness, irritation, itching, burning, stinging or grittiness. When signs are present, symptoms of visual disturbance such as poor vision and blurred vision are sufficient as a symptom of dry eye disease too
• must have best corrected visual acuity in at least one eye of at least 6/12.

Exclusion Criteria:

• lacks capacity (e.g. dementia)
• poor understanding of English
• active other apparent ocular surface disease (including conjunctivitis, abrasion, recurrent erosion syndrome, episcleritis, inflamed pingueculum or pterygium, tumour, infectious keratitis).
• immune ocular pathology (including scleritis and uveitis).
• recent (within the last 3 months) or planned ocular surgery or intravitreal injections.
• current use of other ocular medication, e.g. antiglaucoma drops, g ciclosporine.
• use of artificial tears or ointment in the last 1 month.
• gross lid abnormalities, including significant ectropion or entropion; facial nerve palsy; thyroid eye disease; trichiasis.

For the qualitative interview study:

Subject inclusion criteria

- London NHS Consultant with at least 6 months experience as a Consultant, with a special interest in Cornea and External Diseases, Accident and Emergency and Primary Care, or General Ophthalmology

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OSDI	Ocular Surface Disease Index, consists of 12 questions asking about frequency of dry eye symptoms, each scored on a 0-4 scale. Total score varies from 0 to 100, the lower the better. This score is calculated by the sum of the scores for all 12 questions answered multiplied by 100, which is divided by the total number of questions answered times four. It has 3 subscales: vision-related function, ocular symptoms, and environmental triggers, similarly calculated and similarly varying from 0 to 100.	1 month
SANDE	Symptom Assessment iN Dry Eye. The two-item SANDE questionnaire score is calculated by multiplying the frequency of symptoms score with the severity of symptoms score and obtaining the square root, leading to a score from 0 to 100. The lower the score, the less severe the symptoms. The answers are given on a 100mm horizontal visual analogue scale.	1 month

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: Fight for Sight

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 23, 2018
• Primary Completion (ANTICIPATED): August 23, 2021
• Study Completion (ANTICIPATED): August 23, 2021

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: August 28, 2018
• First Posted (ACTUAL): August 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 29, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Lacrimal Apparatus Diseases; Conjunctival Diseases; Corneal Diseases; Eyelid Diseases; Eye Manifestations; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Keratitis; Conjunctivitis; Meibomian Gland Dysfunction; Keratoconjunctivitis; Blepharitis; Xerophthalmia; Eye Pain; Pharmaceutical Solutions; Ophthalmic Solutions; Lubricant Eye Drops
• Other Study ID Numbers: 233506

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No