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Status unknownNCT03652415DROPSUpdated Aug 31, 2018

DRy Eye Outcome and Prescription Study

An observational study in Dry Eye, Dry Eye Syndrome and Blepharitis, sponsored by Guy's and St Thomas' NHS Foundation Trust. Status unknown at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-31.

Sponsored by Guy's and St Thomas' NHS Foundation Trust · Observational

The sponsor has not verified this record recently (last verified Aug 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
635
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Dry Eye
  • Dry Eye Syndrome
  • Blepharitis
  • Meibomian Gland Dysfunction
  • Eye Pain
  • Punctate Epithelial Keratitis
  • Punctate Keratitis
  • Tear Film Insufficiency
  • Kerato Conjunctivitis Sicca
  • Eye Diseases
03

In context

Dry Eye Syndromes

1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.

This study's planned enrollment of 635 is above the median of 89 across 190 observational studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 295 studies on the registry; 80 are open to participants now.

Browse Guy's and St Thomas' NHS Foundation Trust studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
635 participants (estimated)
Target follow-up
1 Month
Patient registry
Yes

Interventions

  • DeviceArtificial tears (classified by MHRA as a medical device)

    Use of artificial tears

    Also known as: Lubricant drops or ointment

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 month

  2. 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.

    Time frame: 1 month

07

Study locations

2 of 2 sites recruiting
  • Guys and St Thomas' Hospital
    London, United Kingdom
    Recruiting
  • Guys and St Thomas's Hospital
    London, United Kingdom
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2018 (actual). Primary completion is estimated for Aug 2021, 36 months after the start.

Of 53 non-industry observational studies under Dry Eye Syndromes, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 64. This study's planned 36 months is above that.

Counting every sponsor, half of 69 studies reached it within 12 months; a quarter within 5 and three quarters within 64.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 23, 2018
First posted
Aug 29, 2018
StartActual
Aug 23, 2018
Primary completionEst.
Aug 23, 2021
CompletionEst.
Aug 23, 2021
Last update
Aug 31, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03652415
Lead sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
Fight for Sight
Responsible party
Sponsor
First posted
Aug 29, 2018
Start date
Aug 23, 2018
Primary completion
Aug 23, 2021 (estimated)
Completion
Aug 23, 2021 (estimated)
Last update
Aug 31, 2018

Study contacts

Jelle Vehof
Contact
maria.bell@kcl.ac.uk
02071889055

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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