NCT03052140

Lamelleye vs Comparator for the Treatment of Dry Eye Disease

Post-approval Study to Assess Lamelleye vs Comparator for the Treatment of Dry Eye Disease in Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Glasgow Caledonian University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Single-blind, randomised, single centre, 2-way crossover study to collect post-market clinical follow-up data on the CE-marked Lamelleye dry eye drops medical device.

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. This study design allows observations to be made between the treatments at both an intra- and inter-patient level regarding relationships between the patients' disease specific quality of life, symptoms and adverse events.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DEVICE	Lamelleye Dry Eye Drops	Liposomal multi-dose preservative-free sterile suspension which contains soy lecithin phospholipids, sphingomyelin and cholesterol, suspended in saline.
DEVICE	Optive Plus	Multi-dose sterile solution which contains sodium carboxymethylcellulose, glycerine, Castor Oil, Polysorbate 80, levocarnitine, and erythritol, preserved with PURITE® which breaks down into natural tear components in the eye

Timeline

• Start date: 2017-02-21
• Primary completion: 2017-08-09
• Completion: 2017-08-09
• First posted: 2017-02-14
• Last updated: 2017-08-28

Locations

1 site across 1 country: United Kingdom