Evaporative Dry Eye Disease, Meibomian Gland Dysfunction
Conditions
Keywords
Dry eye, MGD
Brief summary
The purpose of this post-approval study is to demonstrate that iLux treatment offers comparable treatment effectiveness to LipiFlow for MGD treatment at 12 months post single treatment.
Detailed description
Subjects will be expected to attend a total of 8 study visits, including Screening/Baseline, Treatment, and follow-up visits at Week 2 and Months 1, 3, 6, 9, and 12.
Interventions
DEVICESystane iLux® Dry Eye System
Commercially available medical device intended for use by qualified eye care professionals to apply localized heat and pressure therapy to a patient's eyelids.
DEVICELipiFlow® Thermal Pulsation System
Commercially available medical device intended for use by qualified eye care professionals to apply localized heat and pressure therapy to a patient's eyelids.
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Understand and sign an Informed Consent document; * Have Meibomian Gland Dysfunction with evaporative dry eye disease at the screening visit; * Agree not to wear contact lenses for the duration of the study; * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* History of eye surgery, as specified in the protocol; * Eye infection or inflammation, as specified in the protocol; * Eyelid abnormalities; eyelid tattoos; * Treated with LipiFlow or iLux in either eye in the last 12 months; * Contact lens wear within the 1 month prior to Screening; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Least Squares Mean Change From Baseline in Meibomian Gland Score (MGS) at Month 12 | Baseline, Month 12 | Meibomian glands on the eyelids were assessed by the examiner using a Meibomian Gland Evaluator and a slit lamp microscope. 5 glands in 3 zones (nasal, medial, temporal) were evaluated for each eye and scored from 0 to 3, with a resultant overall score (MGS) of 0 to 45 for each eye. Scoring was follows: 0 = no secretion (worst), 1 = inspissated, 2 = cloudy, 3 = clear liquid (best). A higher change from baseline score indicates an improvement in meibomian gland function. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 15 investigative sites located in the United States.
Pre-assignment details
Of the 299 enrolled subjects, 63 were excluded prior to randomization as screen failures. This reporting group includes all randomized subjects/eyes (236/472).
Participants by arm
| Arm | Count |
|---|---|
| iLux Single treatment with the Systane iLux Dry Eye System and 12-month follow-up. Both eyes were treated. | 119 |
| LipiFlow Single treatment with the LipiFlow Thermal Pulsation System and 12-month follow-up. Both eyes were treated. | 117 |
| Total | 236 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 1 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Other Reasons | 2 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | iLux | Total | LipiFlow |
|---|---|---|---|
| Age, Continuous | 58.4 years STANDARD_DEVIATION 13.4 | 57.3 years STANDARD_DEVIATION 13.8 | 56.2 years STANDARD_DEVIATION 14.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 7 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 114 Participants | 229 Participants | 115 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 13 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 10 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 103 Participants | 211 Participants | 108 Participants |
| Region of Enrollment United States | 119 participants | 236 participants | 117 participants |
| Sex: Female, Male Female | 94 Participants | 180 Participants | 86 Participants |
| Sex: Female, Male Male | 25 Participants | 56 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 236 | 0 / 238 | 0 / 119 | 0 / 234 | 0 / 117 |
| other Total, other adverse events | 0 / 236 | 0 / 238 | 0 / 119 | 0 / 234 | 0 / 117 |
| serious Total, serious adverse events | 0 / 236 | 0 / 238 | 3 / 119 | 0 / 234 | 1 / 117 |
Outcome results
Primary
Least Squares Mean Change From Baseline in Meibomian Gland Score (MGS) at Month 12
Meibomian glands on the eyelids were assessed by the examiner using a Meibomian Gland Evaluator and a slit lamp microscope. 5 glands in 3 zones (nasal, medial, temporal) were evaluated for each eye and scored from 0 to 3, with a resultant overall score (MGS) of 0 to 45 for each eye. Scoring was follows: 0 = no secretion (worst), 1 = inspissated, 2 = cloudy, 3 = clear liquid (best). A higher change from baseline score indicates an improvement in meibomian gland function.
Time frame: Baseline, Month 12
Population: Full Analysis Set with data at visit
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| iLux | Least Squares Mean Change From Baseline in Meibomian Gland Score (MGS) at Month 12 | 17.4 score on a scale | Standard Error 1.97 |
| LipiFlow | Least Squares Mean Change From Baseline in Meibomian Gland Score (MGS) at Month 12 | 17.8 score on a scale | Standard Error 1.98 |
Mixed effects repeated measures