NCT03140111

LAMELLEYE for the Treatment of Dry Eye Symptoms in pSS Patients

Post-approval Study to Assess the Effectiveness of LAMELLEYE vs Comparator for the Treatment of Dry Eye Symptoms in Patients With Primary Sjögren's Syndrome

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: NHS Greater Glasgow and Clyde · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

Single-blind, randomised, single centre, 2-way crossover pilot study to investigate the effectiveness of LAMELLEYE for the treatment of dry eye symptoms in patients with primary Sjögren's Syndrome.

Detailed description

The study is a 2-way crossover design comprising 2 treatments: the CE-marked LAMELLEYE dry eye drops, and a CE-marked comparator product. All Participants will be allocated to a treatment group in a random order. The study design allows observations to be made between the treatments at both an intra- and inter-patient level regarding relationships between the patient's disease specific quality of life, symptoms and adverse events, and satisfaction with treatments.

Conditions

• Dry Eye Syndromes
• Primary Sjögren Syndrome

Interventions

Type	Name	Description
DEVICE	LAMELLEYE	Liposomal multi-dose preservative-free sterile suspension which contains soy lecithin phospholipids, sphingomyelin and cholesterol, suspended in saline.
DEVICE	OPTIVE FUSION	Multi-dose sterile solution which contains sodium hyaluronate 0.1%, sodium carboxymethylcellulose 0.5%, glycerine 0.9%, erythritol, boric acid, sodium citrate dihydrate, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, and is preserved with PURITE® 0.01% which breaks down into natural tear components on the eye.

Timeline

• Start date: 2017-10-16
• Primary completion: 2018-03-30
• Completion: 2018-03-30
• First posted: 2017-05-04
• Last updated: 2017-09-11