Dry EyeDROPSNCT03652415
DRy Eye Outcome and Prescription Study
An observational study of Dry Eye and Dry Eye Syndrome, run by Guy's and St Thomas' NHS Foundation Trust at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye, Dry Eye Syndrome, Blepharitis
- What is being tested?
- Artificial tears (classified by MHRA as a medical device)
- Type of treatment
- Medical device
- How many people
- 635 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 23 Aug 2018to 23 Aug 2021
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients attending hospital ophthalmology outpatient clinics and emergency care (Eye Casualty). Dry eye can be the presenting problem or a secondary problem.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Guys and St Thomas' Hospital
London
Chris Hammond, 02071889055, maria.bell@kcl.ac.uk
- Recruiting
Guys and St Thomas's Hospital
London
Jelle Vehof, 02071889055, maria.bell@kcl.ac.uk
02071889055, maria.bell@kcl.ac.uk
About this study
Official title: 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.
- Conditions
- Dry Eye, Dry Eye Syndrome, Blepharitis, Meibomian Gland Dysfunction, Eye Pain, Punctate Epithelial Keratitis
- Being tested
- Artificial tears (classified by MHRA as a medical device)
- Medical subject headings
- Dry Eye Syndromes, Blepharitis, Meibomian Gland Dysfunction, Eye Pain, Xerophthalmia, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial tears (classified by MHRA as a medical device)Device
Also called Lubricant drops or ointment
Use of artificial tears
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start23 Aug 2018
- Primary completion23 Aug 2021 (estimated)
- Study completion23 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 635 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Fight for Sight
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652415
- Sponsor's protocol ID
- 233506
- Acronym
- DROPS
- Status last verified
- Aug 2018
- First submitted
- 23 Aug 2018
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dry Eye Outcome and Prescription Study
- ClinicalTrials.gov ID
- NCT03652415
- Acronym / sponsor ID
- DROPS / 233506
- Conditions
- Dry Eye, Dry Eye Syndrome, Blepharitis, Meibomian Gland Dysfunction, Eye Pain, Punctate Epithelial Keratitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 635 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Fight for Sight
- Study start
- 23 Aug 2018 (actual)
- Primary completion
- 23 Aug 2021 (estimated)
- Study completion
- 23 Aug 2021 (estimated)
- First posted
- 29 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending hospital ophthalmology outpatient clinics and emergency care (Eye Casualty). Dry eye can be the presenting problem or a secondary problem.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial tears (classified by MHRA as a medical device)Also: Lubricant drops or ointmentUse of artificial tears | Device | – |
Primary outcome
OSDI
Time frame: 1 month
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.
SANDE
Time frame: 1 month
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye and Dry Eye Syndrome, run by Guy's and St Thomas' NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jelle Vehof (02071889055, maria.bell@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OSDI (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.