Evaluation of the performance of new substitute tears in dry eye patients
| ISRCTN | ISRCTN16288419 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16288419 |
| Secondary identifying numbers | 2019/ST/048 |
- Submission date
- 28/07/2020
- Registration date
- 05/08/2020
- Last edited
- 20/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
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
Contact information
Scientific
Ospedale L. Sacco
Via GB Grassi 74
Milan
20157
Italy
 ORCID ID |
0000-0002-6317-8848 |
|---|---|
| Phone | +39-02-50319842 |
| stefano.barabino@unimi.it |
Study information
| Study design | Interventional double masked randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | Substitute tear containing hyaluronic acid and low concentration of hydrocortisone improves symptoms and signs of dry eye disease |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 07/03/2019 |
| Completion date | 10/04/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 10/06/2020 |
| Date of final enrolment | 10/04/2021 |
Locations
Countries of recruitment
- Italy
Study participating centre
via GB Grassi 74
Milan
20157
Italy
Sponsor information
Hospital/treatment centre
via GB Grassi 74
Milan
20157
Italy
| Phone | +39-02-50319842 |
|---|---|
| cloculistica.sacco@unimi.it | |
| Website | https://www.asst-fbf-sacco.it |
"ROR" |
https://ror.org/0025g8755 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/06/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 19/06/2023 | 20/06/2023 | Yes | No |
Editorial Notes
20/06/2023: Publication reference and total final enrolment added.
05/08/2020: Trial’s existence confirmed by Comitato Etico Milano Area 1.
