Evaluation of the performance of new substitute tears in dry eye patients

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16288419

Enrollment

Registered

2020-08-05

Start date

2020-06-10

Completion date

Unknown

Last updated

2023-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry eye disease Eye Diseases

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Symptom improvement measured by SANDE score at day 7, 28, 56, 180	—

Secondary

Measure	Time frame
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	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 9, 2026