Plain English Summary
Background and study aims
Dry eye disease (when the eyes do not make enough tears, or the tears evaporate too quickly) is very common and affects millions of people around the world.
The aim of the study is verify the efficacy of a substitute tear containing 0.001% hydrocortisone to improve symptoms and inflammation in dry eye patients.
Who can participate?
Patients older than 18 years who have suffered from dry eye symptoms for at least 6 months
What does the study involve?
Participants will be randomly allocated to receive eye drops with or without 0.001% hydrocortisone. These will be used twice daily for one week to check for any problems. After the first week the drops will be used 4 times a day for 6 months. Participants will visit the clinic to be tested on day 7, 28, 56, 180.
What are the possible benefits and risks of participating?
The product used in the study has not demonstrated any side effects so far.
Where is the study run from?
Ocular Surface and Dry Eye Center, Sacco Hospital, Milan (Italy)
When is the study starting and how long is it expected to run for?
March 2019 to April 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Stefano Barabino, MD, PhD, at email@example.com
Evaluation of the performance of a substitute tear containing hyaluronic acid and a low concentration of hydrocortisone to control ocular surface inflammation and symptoms in patients with dry eye disease
Substitute tear containing hyaluronic acid and low concentration of hydrocortisone improves symptoms and signs of dry eye disease
Approved 19/9/2019 Milan Area 1 Ethic Committee (Luigi Sacco hospital, via G.B. Grasi 74, Milan, Italy; +39 0239043518; firstname.lastname@example.org), ref: 39408/2019
Interventional double masked randomized study
Primary study design
Secondary study design
Randomised parallel trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Dry eye disease
Patients are randomized in study and control group using a pre-defined list. All patients will use topical steroid Fluorometholone twice daily and treatment (HA + 0.001% hydrocortisone) or control (HA alone) eye drops twice daily for one week. At the end of the first week, patients will keep using eye drops 4 times a day for 6 months
2. HA + 0.001% hydrocortisone
Primary outcome measure
Symptom improvement measured by SANDE score at day 7, 28, 56, 180
Secondary outcome measures
1. Corneal fluorescein staining, NEI scale, at day 7, 28, 56,180
2. Lissamine green conjunctival staining, NEI scale, at day 7, 28, 56, 180
3. Tear break-up time (BUT), seconds, at day 7, 28, 56, 180
4. Intraocular pressure (IOP), mmHg, at day 7, 28, 56, 180
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Dry eye symptoms for at least 6 months, and one of the following signs:
1.1. Corneal fluorescein staining ≥3 (NEI National eye Institute grading scale)
1.2. Conjunctival lissamine green staining ≥3 (NEI National eye Institute grading scale)
1.3. T BUT (Tear Film Break up Time) ≤10 s
Target number of participants
Participant exclusion criteria
1. Patients changing systemic treatment during the study
2. Patients with other ocular surface diseases other than dry eye
5. Ocular surgery in the previous 3 months
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Ospedale L. Sacco-University of Milan
Clinica Oculistica via GB Grassi 74
investigator initiated and funded
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication
Intention to publish date
Participant level data
Basic results (scientific)