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Tixel vs LipiFlow for Meibomian Gland Dysfunction

N/A
Waitlist Available
Led By Erik L. Mertens, MD
Research Sponsored by Novoxel Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ocular Surface Disease Index (OSDI) score between 23-79.
Reports dry eye symptoms for three months prior to the study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up additional 3 months study participation on top of main study 18 months duration
Awards & highlights

Study Summary

This trialwill compare two treatments for meibomian gland dysfunction to see which is more effective and safe.

Who is the study for?
Adults aged 22 and older with dry eye symptoms for at least three months, an OSDI score of 23-79, and Meibomian gland dysfunction in both eyes are eligible. Participants must have expressible glands in the lower eyelids and a TBUT under 10 seconds. They should not be on certain medications or treatments that affect dry eyes or skin healing, nor should they have immune system issues, recent ocular surgery, or contact lens use.Check my eligibility
What is being tested?
The trial is testing two devices: Tixel® and LipiFlow®, to see which one is better at treating Meibomian Gland Dysfunction. It's a controlled study where participants are randomly assigned to receive either treatment while researchers measure effectiveness and safety.See study design
What are the potential side effects?
Potential side effects may include discomfort around the eye area, temporary redness or swelling of the eyelids, irritation from the device application process itself. Specific side effects will depend on each individual's reaction to Tixel® or LipiFlow®.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a moderate to severe ocular surface disease, which is measured by a score between 23-79 on the Ocular Surface Disease Index test.
Select...
You have experienced dry eye symptoms for the past three months.
Select...
You have experienced dry eyes and have been using eye drops or lubricants regularly in the past month to relieve the symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~additional 3 months study participation on top of main study 18 months duration
This trial's timeline: 3 weeks for screening, Varies for treatment, and additional 3 months study participation on top of main study 18 months duration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Tear Break Up Times (TBUT) to the 4-weeks follow-up exam
Comparison of the incidence of device-related Ocular adverse events
Secondary outcome measures
Best corrected distance Visual acuity changes
Changes in MGS to 4-weeks and 12-weeks follow-up exam
Changes in Tear Break Up Times (TBUT) to the 12-weeks follow-up exam
+4 more
Other outcome measures
Extension study endpoint 1
Extension study endpoint 2
Extension study endpoint 3

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Tixel GroupExperimental Treatment1 Intervention
Screening and baseline visits, Treatment- 3 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after the last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire.
Group II: LipiFlowActive Control1 Intervention
LipiFlow: Screening and baseline visits,Treatment session, followed by 2 Follow up sessions, 1and 3 months after the last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tixel C
2022
N/A
~150

Find a Location

Who is running the clinical trial?

Novoxel Ltd.Lead Sponsor
8 Previous Clinical Trials
249 Total Patients Enrolled
1 Trials studying Meibomian Gland Dysfunction
21 Patients Enrolled for Meibomian Gland Dysfunction
Erik L. Mertens, MDPrincipal InvestigatorMedipolis

Media Library

LipiFlow Clinical Trial Eligibility Overview. Trial Name: NCT05162261 — N/A
Meibomian Gland Dysfunction Research Study Groups: Tixel Group, LipiFlow
Meibomian Gland Dysfunction Clinical Trial 2023: LipiFlow Highlights & Side Effects. Trial Name: NCT05162261 — N/A
LipiFlow 2023 Treatment Timeline for Medical Study. Trial Name: NCT05162261 — N/A
Meibomian Gland Dysfunction Patient Testimony for trial: Trial Name: NCT05162261 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial still accepting new enrollees?

"Affirmative. The clinical trial's information on the website, which was initially launched on September 19th 2022, reflects that they are currently recruiting 110 participants from 3 distinct locations."

Answered by AI

What is the primary objective of this clinical experiment?

"This 18-month study seeks to assess the risk of device-related adverse events. Secondary objectives include quantifying any changes in intraocular pressure, assessing patient discomfort with a VAS score from 1 - 10 and evaluating changes in Meibomian Gland Score (MGS) over 4 weeks and 12 weeks follow up visits."

Answered by AI

What is the upper limit in terms of participants for this clinical trial?

"Affirmative. According to clinicaltrials.gov, this research program is currently recruiting volunteers who meet the eligibility criteria. First published on September 19th 2022, it has since been revised and now requires 110 participants from three distinct sites."

Answered by AI

Who else is applying?

What state do they live in?
California
Connecticut
What site did they apply to?
Gordon Schanzlin New Vision Institute
PNV Clinical Research, LLC
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0

Why did patients apply to this trial?

Looks like a good study for my eye condition. My ability to see is getting worse and my eyes are always tearing now when i go outside.
PatientReceived no prior treatments
I was recently diagnosed with dry eye disease in both eyes and suffer stabbing pain and did.
PatientReceived no prior treatments
My ability to see is getting worse and my eyes are always tearing now when i go outside. I have been using over the retaine and restasis for a year and my dry eyes aren’t getting better.
PatientReceived 1 prior treatment
I was diagnosed with meibomian gland disfunction and have had dry eye symptoms for the past 2 years. I have used different eye drops to try and relive the symptoms. I have not attempted more aggressive treatment because my insurance does not cover the treatment.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

What does the trial consist of? Can I choose between the eyedrops and the Lipiflow treatment?
PatientReceived 1 prior treatment

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. Gordon Schanzlin New Vision Institute: < 48 hours
~44 spots leftby Mar 2025