Condition category
Eye Diseases
Date applied
28/07/2020
Date assigned
05/08/2020
Last edited
05/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

https://www.asst-fbf-sacco.it

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

Publication citations

Additional files

Editorial Notes

05/08/2020: Trial’s existence confirmed by Comitato Etico Milano Area 1.