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

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2020
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 CONDITION: Dry eye disease ; Eye Diseases PRIMARY OUTCOME: Symptom improvement measured by SANDE score at day 7, 28, 56, 180 SECONDARY OUTCOME: ; 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; 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
Epistemonikos ID: 400d6413647f0568061eea870467f3b8fbf39117
First added on: Aug 24, 2024