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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up additional 3 months study participation on top of main study 18 months duration
Awards & highlights
No Placebo-Only Group
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.
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.
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®.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ additional 3 months study participation on top of main study 18 months duration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~additional 3 months study participation on top of main study 18 months duration
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreOther study objectives
Extension study endpoint 1
Extension study endpoint 2
Extension study endpoint 3
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~160
Find a Location
Who is running the clinical trial?
Novoxel Ltd.Lead Sponsor
8 Previous Clinical Trials
258 Total Patients Enrolled
1 Trials studying Meibomian Gland Dysfunction
30 Patients Enrolled for Meibomian Gland Dysfunction
Erik L. Mertens, MDPrincipal InvestigatorMedipolis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are 22 years or older, regardless of your gender or race.You have a moderate to severe level of discomfort related to dry eyes.You wear contact lenses and cannot remove them for at least a month before the study and during the study.You have skin problems, such as burns, blisters, or irritation, in the areas that need treatment.You cannot have used any other experimental eye treatment or device within 30 days before starting the study.You have a medical history of conditions that affect the formation of skin tissues or wound healing.You currently have an active eye infection called ocular herpes or a history of this infection.You have received Botulinum-Toxin injections in the treatment area within the past 6 months.You have been experiencing dry eye symptoms for the past three months before the study.You have a total Meibomian Gland Secretion Score of ≤12 in each eye.You have tattoos or permanent makeup in the area where treatment will be done.You have a weakened immune system or taking medications that suppress your immune system.You have had an eye injury or surgery, or have a condition called limbal stem cell deficiency, within the last three months before the study.You have used certain medications or treatments on your skin in the past 3 months that may make your skin more delicate or slow down healing.You do not have a natural lens in one or both of your eyes.You have certain medical conditions that can cause dry eyes, like rheumatoid arthritis or lupus.You have a medical condition that could impact the safety or effectiveness of the treatment, or make it difficult for you to follow the study guidelines.You have a condition called giant papillary conjunctivitis.You have had severe eye inflammation in the past 3 months or have a history of chronic eye inflammation.You have been using eye drops or other lubricants frequently in the past month to treat dry eyes.
Research Study Groups:
This trial has the following groups:- Group 1: Tixel Group
- Group 2: LipiFlow
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Meibomian Gland Dysfunction Patient Testimony for trial: Trial Name: NCT05162261 — N/A
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