Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

DRy Eye Outcome and Prescription Study (DROPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03652415
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : August 31, 2018
Sponsor:
Collaborator:
Fight for Sight
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

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.

Condition or disease Intervention/treatment
Dry Eye Dry Eye Syndrome Blepharitis Meibomian Gland Dysfunction Eye Pain Punctate Epithelial Keratitis Punctate Keratitis Tear Film Insufficiency Kerato Conjunctivitis Sicca Eye Diseases Device: Artificial tears (classified by MHRA as a medical device)

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 635 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Dry Eye Outcome and Prescription Study
Actual Study Start Date : August 23, 2018
Estimated Primary Completion Date : August 23, 2021
Estimated Study Completion Date : August 23, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears


Intervention Details:
  • Device: Artificial tears (classified by MHRA as a medical device)
    Use of artificial tears
    Other Name: Lubricant drops or ointment


Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652415


Contacts
Layout table for location contacts
Contact: Jelle Vehof 02071889055 maria.bell@kcl.ac.uk

Locations
Layout table for location information
United Kingdom
Guys and St Thomas' Hospital Recruiting
London, United Kingdom
Contact: Chris Hammond    02071889055    maria.bell@kcl.ac.uk   
Guys and St Thomas's Hospital Recruiting
London, United Kingdom
Contact: Jelle Vehof    02071889055    maria.bell@kcl.ac.uk   
Contact    02071889055    maria.bell@kcl.ac.uk   
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Fight for Sight

Additional Information:

Layout table for additonal information
Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03652415    
Other Study ID Numbers: 233506
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctivitis
Keratitis
Blepharitis
Eye Pain
Xerophthalmia
Keratoconjunctivitis
Eye Diseases
Conjunctival Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Eyelid Diseases
Eye Manifestations
Signs and Symptoms
Pain
Neurologic Manifestations
Lubricant Eye Drops
Ophthalmic Solutions
Pharmaceutical Solutions