NCT04485533

Clinical Investigation to Assess the Efficacy and the Safety of VisuXL® Gel Administered in Patients Affected by Moderate DED

Clinical Investigation to Assess the Efficacy and the Safety of VisuXL® Ophthalmic Gel Administered in Patients Affected by Moderate Dry Eye Disease (DED): a Randomized, Cross Over, Double Blind Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: VISUfarma SpA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a post-market, european multicenter study. This is a randomized, cross-over, double blind study with competitive enrolment, aimed to enroll a total of 90 patients with a diagnosis of moderate dry eye disease (DED).

Detailed description

The purpose of the study is to evaluate the non-inferiority of the new treatment versus the comparator. Patients, after signing the Informed Consent, will enter into a 1-week screening phase during which the baseline tests will be conducted. Baseline (V0), Day 30 ± 1 week (V1), Day 38 ± 2 days (V2), Day 68 ±1 week (V3) of treatment. Between V1 and V2 one week of wash out should be performed. Of note, all ophthalmologic evaluations listed in the Flow-Chart will be performed on both eyes of the patient.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DEVICE	VisuXL® Gel	VisuXL® ophthalmic gel, available in a multidose 10ml bottle without preservatives based on Coenzyme Q10, Vitamin E TPGS and cross-linked sodium carboxymethylcellulose. Dose/dosage: 1 drop per eye twice a day.
DEVICE	HYLO®	HYLO® ophthalmic solution, a phosphate- and preservative-free sterile eye drops containing 2 mg/ml of hyaluronic acid sodium salt, a citrate buffer, sorbitol and water. Dose/dosage: 1 drop per eye twice a day

Timeline

• Start date: 2020-07-06
• Primary completion: 2021-04-30
• Completion: 2021-04-30
• First posted: 2020-07-24
• Last updated: 2020-07-24

Locations

3 sites across 3 countries: France, Italy, Spain