NCT05306561

Evaluating Impact of Systane iLux on Dryness Symptoms and Wearing Time in Contact Lens Users

A Single Arm, Single Center Phase 4 Study to Evaluate Impact of a Single Systane iLux MGD Treatment Device Thermal Pulsation Treatment on Contact Lens Wearing Time and Tolerability, Meibomian Gland Secretion Scores, and Subjective Dry Eye Symptoms in Soft Contact Lens Wearing Subjects With Meibomian Gland Dysfunction

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Periman Eye Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To evaluate dry eye symptoms and contact lens wearing times after a single iLux treatment by evaluating change from baseline in OSDI scores, subjective CLDEQ8 and CL wearing time questionnaires, and meibomian gland secretion scores.

Detailed description

A single arm, single center phase 4 study to evaluate impact of a single Systane iLux MGD Treatment Device thermal pulsation treatment on contact lens wearing time and tolerability, meibomian gland secretion scores, and subjective dry eye symptoms in soft contact lens wearing subjects with meibomian gland dysfunction.

Conditions

• Meibomian Gland Dysfunction
• Dry Eye

Interventions

Type	Name	Description
PROCEDURE	Systane iLux thermal pulsation treatment	Systane iLux thermal pulsation uses light emitting diode (LED) technology to emit light that is absorbed by pigments (melanin and hemoglobin) in the eyelid. The pigments convert the light energy to heat, which is then transferred to the surrounding tissues, including the meibomian glands. The device heats the eyelid to 40-42°C and maintains it above 40°C during the heating period, which can be 40 seconds or more. This helps melt the meibum. After the heating phase, the meibomian glands are expressed with the built in expression system.

Timeline

• Start date: 2022-01-26
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2022-04-01
• Last updated: 2023-11-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study