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Tixel vs LipiFlow for Meibomian Gland Dysfunction
Study Summary
This trialwill compare two treatments for meibomian gland dysfunction to see which is more effective and safe.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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 are 22 years of age or older and can participate regardless of your gender or race.You have experienced dry eye symptoms for the past three months.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 moderate to severe ocular surface disease, which is measured by a score between 23-79 on the Ocular Surface Disease Index test.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 experienced dry eyes and have been using eye drops or lubricants regularly in the past month to relieve the symptoms.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.
- Group 1: Tixel Group
- Group 2: LipiFlow
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
What questions have other patients asked about this trial?
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Most responsive sites:
- Gordon Schanzlin New Vision Institute: < 48 hours
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