NCT03652415

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
635

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

August 23, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2021

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

3 years

First QC Date

August 23, 2018

Last Update Submit

August 29, 2018

Conditions

Dry EyeDry Eye SyndromeBlepharitisMeibomian Gland DysfunctionEye PainPunctate Epithelial KeratitisPunctate KeratitisTear Film InsufficiencyKerato Conjunctivitis SiccaEye Diseases

Outcome Measures

Primary Outcomes (2)

  • 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

Interventions

Artificial tears (classified by MHRA as a medical device)DEVICE

Use of artificial tears

Also known as: Lubricant drops or ointment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Guys and St Thomas' Hospital

London, United Kingdom

RECRUITING

Guys and St Thomas's Hospital

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Dry Eye SyndromesBlepharitisMeibomian Gland DysfunctionEye PainXerophthalmiaEye Diseases

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEyelid DiseasesEye ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsConjunctival Diseases

Central Study Contacts

Jelle Vehof

CONTACT

02071889055maria.bell@kcl.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2018

First Posted

August 29, 2018

Study Start

August 23, 2018

Primary Completion

August 23, 2021

Study Completion

August 23, 2021

Last Updated

August 31, 2018

Record last verified: 2018-08

Locations

GB(2)