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LAMELLEYE for the Treatment of Dry Eye Symptoms in pSS Patients

NCT03140111 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-09-11

No results posted yet for this study

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.

Conditions

  • Dry Eye Syndromes
  • Primary Sjögren Syndrome

Interventions

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.

Sponsors & Collaborators

  • Lamellar Biomedical Ltd

    collaborator INDUSTRY

  • Robertson Centre for Biostatistics - University of Glasgow

    collaborator UNKNOWN

  • Glasgow Caledonian University

    collaborator OTHER

  • NHS Greater Glasgow and Clyde

    lead OTHER

Principal Investigators

  • Monica Gupta · NHS Greater Glasgow & Clyde

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-16
Primary Completion
2018-03-30
Completion
2018-03-30

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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 NCT03140111 on ClinicalTrials.gov