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

Not Applicable

Completed

• Conditions: Dry eye disease; Eye Diseases

• Registration Number: ISRCTN16288419
• Lead Sponsor: uigi Sacco Hospital

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37334889/ (added 20/06/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-05
• Study Completion: 2021-04-10
• Last Update Posted: 4 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptom improvement measured by SANDE score at day 7, 28, 56, 180

Secondary Outcome Measures

Name	Time	Method
<br> 1. Corneal fluorescein staining, NEI scale, at day 7, 28, 56,180<br> 2. Lissamine green conjunctival staining, NEI scale, at day 7, 28, 56, 180<br> 3. Tear break-up time (BUT), seconds, at day 7, 28, 56, 180<br> 4. Intraocular pressure (IOP), mmHg, at day 7, 28, 56, 180<br>