DRy Eye Outcome and Prescription Study

Dry Eye Clinical Trial

— DROPS  

Official title:

Dry Eye Outcome and Prescription Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03652415
• Other study ID #: 233506
• Status: Recruiting
• Start date: August 23, 2018
• Est. completion date: August 23, 2021

Study information

• Verified date: August 2018
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Jelle Vehof
• Phone: 02071889055
• Email: maria.bell[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 635
• Est. completion date: August 23, 2021
• Est. primary completion date: August 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Artificial tears (classified by MHRA as a medical device)
Use of artificial tears

Locations

Country	Name	City	State
United Kingdom	Guys and St Thomas' Hospital	London
United Kingdom	Guys and St Thomas's Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	Fight for Sight

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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