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Experimental Arm for Dry Eye Syndrome

Phase 4
Waitlist Available
Research Sponsored by Gordon Schanzlin New Vision
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 30 days
Awards & highlights

Study Summary

This trial is studying a new eye drop called Miebo that has been approved by the FDA for treating MGD. Previous research on Miebo has only been done on people who do not wear

Who is the study for?
This trial is for adults over 18 who regularly wear contact lenses and have experienced dry eyes. They must be willing to follow the study rules and sign a consent form. People with previous Miebo use or allergies, certain eye conditions, or women able to get pregnant not using birth control can't join.Check my eligibility
What is being tested?
The trial tests Miebo eyedrops in people who wear soft contact lenses to see if it improves their comfort. Miebo is a new FDA-approved treatment for dry eyes caused by Meibomian Gland Dysfunction (MGD) but hasn't been studied in lens wearers yet.See study design
What are the potential side effects?
Potential side effects of Miebo are not detailed here, but as an ophthalmic drop, they could include temporary discomfort upon application, redness, itching or swelling around the eye area.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The of this clinical trial is to evaluate the safety of Miebo for contact lens wearers.
Secondary outcome measures
The of this clinical trial is to evaluate the tolerability of Miebo for contact lens wearers.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental ArmExperimental Treatment1 Intervention
This is a single arm open label study with no randomization or control group. All participants will receive the Miebo eye drop for use while enrolled in the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Miebo
2023
Completed Phase 4
~50

Find a Location

Who is running the clinical trial?

Gordon Schanzlin New VisionLead Sponsor
1 Previous Clinical Trials

Frequently Asked Questions

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

Has the experimental treatment been granted approval by the FDA?

"The Experimental Arm of this clinical trial, being a Phase 4 study and an approved treatment, is rated as having the highest safety rating of 3 by our team at Power."

Answered by AI

Is this medical study currently open to new participants?

"Indeed, as per the information provided by clinicaltrials.gov, this study is actively seeking eligible participants. The trial was initially posted on September 21st, 2023 and underwent its most recent revision on December 18th, 2023."

Answered by AI

What is the current total number of participants being recruited for this clinical study?

"Indeed, the information available on clinicaltrials.gov confirms that this trial is currently accepting patients for enrollment. The initial posting of the trial was made on September 21st, 2023 and it has been recently updated as of December 18th, 2023. The study aims to enroll a total of 50 patients at a single site."

Answered by AI
~31 spots leftby Apr 2025