Evaluation of symptoms and signs of evaporative dry eye with a lipid-enhanced artificial tear drop
| ISRCTN | ISRCTN10208997 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10208997 |
| EudraCT/CTIS number | Nil Known |
- Submission date
- 14/08/2024
- Registration date
- 16/08/2024
- Last edited
- 16/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
This study aimed to assess how well an eye drop containing propylene glycol (PG) and hydroxypropyl guar (HPG) (Systane complete) can help with dry-eye symptoms and eye health in people with evaporative dry eye (EDE).
Who can participate?
Participants in the study were adults aged 18 to 50 with EDE.
What does the study involve?
Participants were asked to use the PG-HPG eye drops three times a day for 90 days. The researchers evaluated the effectiveness of the treatment by looking at several factors, including dry eye symptoms and dry eye signs (tear osmolarity, tear meniscus height, lipid layer thickness, noninvasive tear break-up time, fluorescein tear break-up time, corneal staining and Schirmer’s test I).
What are the possible benefits and risks of participating?
The potential benefits include personalized evaluation of the ocular surface performed during the study, which allows for tailored assessment of the disease and the provision of Systane Complete treatment free of charge to participants. Possible adverse effects may include transient discomfort from some of the tests, such as eye irritation or a sensation of a foreign body, but these symptoms are generally short-lived.
Where is the study run from?
Centro de la Vision (Chile)
When is the study starting and how long is it expected to run for?
December 2022 to March 2024
Who is funding the study?
Alcon Laboratories (USA)
Who is the main contact?
Dr Cristián Cartes, ccartesindo@gmail.com
Contact information
Public, Scientific, Principal Investigator
Ricardo Matte Perez 0347
Santiago
7500956
Chile
 ORCID ID |
0000-0002-8121-6158 |
|---|---|
| Phone | +56 985007180 |
| ccartes@centrodelavision.cl |
Study information
| Study design | Single-center interventional pre-post design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Effect of a propylene glycol-hydroxypropyl guar nanoemulsion in symptoms and ocular surface parameters in patients with evaporative dry-eye |
| Study objectives | The use of propylene glycol-hydroxypropyl guar nanoemulsion teardrop improves dry eye symptoms in patients with evaporative dry eye |
| Ethics approval(s) |
Approved 15/12/2022, Centro de la Vision Ethics Committee (Camino el Alba 9500, Santiago, 7600830, Chile; +56 233030000; hborel@centrodelavision.cl), ref: NA |
| Health condition(s) or problem(s) studied | Evaporative dry eye |
| Intervention | Participants were instructed to instill propylene glycol-hydroxypropyl guar nanoemulsion (Systane Complete) in both eyes three times a day for 90 days. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Systane Complete |
| Primary outcome measure | Dry eye symptoms (Ocular surface disease index questionnaire; OSDI) at baseline, 1 month, and 3 months |
| Secondary outcome measures | 1. Tear break-up time and corneal staining (National Eye Institute scale) were assessed at baseline and at 3 months 2. Osmolarity (measured in mosm/L) was evaluated at baseline and at 3 months using the TearLab Osmometer 3. Lipid layer thickness (categorized as normal/mild/moderate/severe), non-invasive tear break-up time (measured in seconds), and tear meniscus were assessed at baseline and at 3 months using the Keratograph 5M device |
| Overall study start date | 15/12/2022 |
| Completion date | 30/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 30 |
| Key inclusion criteria | 1. 18 and 50 years 2. Symptomatic dry-eye disease, according to (Dry eye workshop II) DEWS II criteria |
| Key exclusion criteria | 1. Contact lens wearers 2. Previous ocular surgery 3. History of major systemic or ocular conditions 4. Active ocular inflammation or inflammatory and autoimmune conditions (I.E. ocular cicatricial pemphigoid, Sjögren’s disease) 5. Glaucoma medications or other concomitant use of drops 6. Schirmer’s test <10 mm |
| Date of first enrolment | 01/09/2023 |
| Date of final enrolment | 20/01/2024 |
Locations
Countries of recruitment
- Chile
Study participating centre
Santiago
7600830
Chile
Sponsor information
Hospital/treatment centre
Camino el Alba 9500
Santiago
7600830
Chile
| Phone | +56 23303000 |
|---|---|
| msrur@centrodelavision.cl |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Location
- United States of America
Results and Publications
| Intention to publish date | 30/09/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The dataset generated during the current study will be available on request from Cristian Cartes (ccartesindo@gmail.com). |
Editorial Notes
15/08/2024: Trial's existence confirmed by Centro de la Vision Ethics Committee
