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 stefano.barabino@unimi.it
Trial website
Contact information
Type
Scientific
Primary contact
Prof Stefano Barabino
ORCID ID
https://orcid.org/0000-0002-6317-8848
Contact details
Ospedale L. Sacco
Via GB Grassi 74
Milan
20157
Italy
+39-02-50319842
stefano.barabino@unimi.it
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
2019/ST/048
Study information
Scientific title
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
Acronym
Study hypothesis
Substitute tear containing hyaluronic acid and low concentration of hydrocortisone improves symptoms and signs of dry eye disease
Ethics approval
Approved 19/9/2019 Milan Area 1 Ethic Committee (Luigi Sacco hospital, via G.B. Grasi 74, Milan, Italy; +39 0239043518; comitato.etico@asst-fbf-sacco.it), ref: 39408/2019
Study design
Interventional double masked randomized study
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Dry eye disease
Intervention
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
Intervention type
Drug
Phase
Not Applicable
Drug names
1. Fluorometholone
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
07/03/2019
Overall trial end date
10/04/2021
Reason abandoned (if study stopped)
Eligibility
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. Patients changing systemic treatment during the study
2. Patients with other ocular surface diseases other than dry eye
3. Pregnancy
4. Diabetes
5. Ocular surgery in the previous 3 months
Recruitment start date
10/06/2020
Recruitment end date
10/04/2021
Locations
Countries of recruitment
Italy
Trial participating centre
Ospedale L. Sacco-University of Milan
Clinica Oculistica
via GB Grassi 74
Milan
20157
Italy
Sponsor information
Organisation
Luigi Sacco Hospital
Sponsor details
via GB Grassi 74
Milan
20157
Italy
+39-02-50319842
cloculistica.sacco@unimi.it
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
01/06/2021
Participant level data
Other
Basic results (scientific)
Publication list