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Lamelleye vs Comparator for the Treatment of Dry Eye Disease

NCT03052140 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2017-08-28

No results posted yet for this study

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.

Conditions

  • Dry Eye Syndromes

Interventions

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

Sponsors & Collaborators

  • Lamellar Biomedical Ltd

    collaborator INDUSTRY

  • University of Glasgow

    collaborator OTHER

  • Glasgow Caledonian University

    lead OTHER

Principal Investigators

  • Ian Pearce · Glasgow Caledonian University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-21
Primary Completion
2017-08-09
Completion
2017-08-09

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03052140 on ClinicalTrials.gov