NCT04889950

Evaluate the Safety and Effectiveness of The Tixel Fractional System in the Treatment of Meibomian Gland Disfunction

A Randomized, Masked (Evaluator), Controlled, Prospective Pilot Study of the Effectiveness and Safety of the Tixel Versus Lipiflow in the Treatment of Meibomian Gland Dysfunction.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Novoxel Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Randomized, Masked (Evaluator), Controlled, Prospective Pilot Study of the Effectiveness and Safety of the Tixel®, Versus LipiFlow® in the Treatment of Meibomian Gland Dysfunction. Up to 30 patients (60 eyes) to be randomized in up to 2 clinical sites in Israel and/or Europe. study subject will receive three (3) treatments with Tixel in a monthly interval, and a single treatment for the control group. Follow-up will occur 1 month and 3 months following the last treatment.

Detailed description

Up to 30 patients (60 eyes), 15 Per Device at up to 2 study sites in Israel and/or Europe will be recruited to evaluate the safety and effectiveness of the Tixel device in adults with Meibomian Gland Dysfunction (MGD). study subject will receive three (3) treatments with Tixel in a monthly interval, and single treatment for the control group. Follow-up will occur 1 month and 3 months following the last treatment. Tixel group study visits will be as follow: Screening: (Must be done up to 7 days prior to initial treatment (Day 0), but can be also done on the same day as baseline testing and initial treatment) Randomization: (Performed after determining that patient is eligible for the study) Treatments - three treatments will be conducted to the study device group. Follow-Up Visits: 4-Weeks (+/-7days) and 12-Weeks (+/-14 days) after last treatment. Control group visit will be as follow: Screening: (Must be done up to 7 days prior to initial treatment (Day 0), but can be also done on the same day as baseline testing and initial treatment) Randomization: (Performed after determining that patient is eligible for the study) Treatment- single Follow-Up Visits: 4-Weeks (+/-7days) and 12-Weeks (+/-14 days) after last treatment.

Conditions

• Dry Eye Syndromes
• Dry Eye
• Meibomian Gland Dysfunction

Interventions

Type	Name	Description
DEVICE	Tixel C	Tixel C )Novoxel®, Israel) is a thermomechanical system developed for fractional treatment. The system is designed for the treatment of soft tissue by direct conduction of heat, enabling tissue coagulation combined with micro ablation with low thermal damage to the surrounding tissue.
DEVICE	LipiFlow	LipiFlow

Timeline

• Start date: 2021-10-26
• Primary completion: 2023-01-04
• Completion: 2023-02-08
• First posted: 2021-05-17
• Last updated: 2024-11-15
• Results posted: 2024-11-15

Locations

1 site across 1 country: Israel