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DRy Eye Outcome and Prescription Study

NCT ID: NCT03652415

Last Updated: 2018-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

635 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-23

Study Completion Date

2021-08-23

Brief Summary

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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.

Detailed Description

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Conditions

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Dry Eye Dry Eye Syndrome Blepharitis Meibomian Gland Dysfunction Eye Pain Punctate Epithelial Keratitis Punctate Keratitis Tear Film Insufficiency Kerato Conjunctivitis Sicca Eye Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Artificial tears (classified by MHRA as a medical device)

Use of artificial tears

Intervention Type DEVICE

Other Intervention Names

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Lubricant drops or ointment

Eligibility Criteria

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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.


\- 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

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:
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fight for Sight

OTHER

Sponsor Role collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Guys and St Thomas' Hospital

London, , United Kingdom

Site Status RECRUITING

Guys and St Thomas's Hospital

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Jelle Vehof

Role: CONTACT

Phone: 02071889055

Email: [email protected]

Facility Contacts

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Chris Hammond

Role: primary

Jelle Vehof

Role: primary

Role: backup

Other Identifiers

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233506

Identifier Type: -

Identifier Source: org_study_id