Radio Frequency (Forma Eye) Treatment for Dry Eye Disease... | NCT04120584

NCT04120584

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
Forma Eye treatment	Experimental		Device: Forma Eye Applicator

Name	Type	Description	Arm Group Labels	Other Names
Forma Eye Applicator	Device	Eligible subjects will receive up to 3 treatments (2-3 weeks interval) with the Forma Eye Applicator according to the study protocol. The subject will return for 3 follow up visits: four weeks (4wk FU), 12 weeks (12wk FU), twenty-four weeks (24wk FU) after the last treatment.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Standardized Patient Evaluation of Eye Dryness (SPEED)	Change dry eye symptoms evaluated by Standardized Patient Evaluation of Eye Dryness (SPEED) This questionnaire gives a score from 0 to 28. Lower score indicates better outcome. 0-4: mild, 5-7: moderate, 8+: severe Scale range: 0 (minimum; no symptoms) to 28 (maximum; most severe symptoms). Interpretation: Lower scores indicate better outcomes. Symptom severity can be categorized as: 0-4 = mild, 5-7 = moderate, 8-28 = severe.	6 months
Meibomian Gland Score (MGS), as Assessed by a Masked Rater	The Meibomian Gland Score (MGS) is a standardized clinical tool used to assess the functional quality of the meibomian glands, which are responsible for secreting the oily layer of the tear film. Dysfunction in these glands is a common cause of dry eye disease and evaporative dry eye. The scoring typically involves gentle expression of the meibomian glands, usually from a designated number of glands (commonly 15, e.g., 5 each from the nasal, central, and temporal parts of the lower eyelid). Each gland is evaluated based on the quality of the secretion it produces. Scoring Criteria per Gland: Each gland is scored on a 0-3 scale: 0 = No secretion = Inspissated/toothpaste-like secretion = Cloudy secretion = Clear, healthy oil If 15 glands are assessed, the maximum total score is 45 (15 glands × 3 points per gland). A higher total MGS reflects better meibomian gland function and healthier tear film, indicating a more favorable condition.	6 months
Tear Break-Up Time	Tear Break-Up Time (TBUT) Changes in dry eye symptoms such as ocular fatigue or dryness will be assessed by TBUT. The measurement is reported in seconds. Scale range: 0 seconds (minimum) to >10 seconds (maximum normal value considered). Interpretation: >10 seconds = normal, 5-10 seconds = marginal, <5 seconds = low.	6 months
Ocular Surface Disease Index (OSDI)	Ocular Surface Disease Index (OSDI) This 12-item questionnaire assesses dry eye symptoms and their effects. Scale range: 0 (minimum) to 100 (maximum). Interpretation: Lower scores indicate better outcomes.

Secondary Outcomes

Measure	Description	Time Frame
Subject's Assessment of Improvement	Subject assessment of improvement based on 0 - 4-point Likert scale. Improvement assessment will be performed independently by the subject himself on the following 0-4 points Likert scale questionnaire (Global Aesthetic Improvement Scale): 4 = Significantly marked improvement; 3 = Marked improvement; 2 = Moderate improvement; 1 = Slight improvement; 0 = No difference Scale range: 0 (no difference) to 4 (significant marked improvement).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult females and males between the ages of 18 -75, seeking treatments for Dry Eye Disease Due to Meibomian Gland Dysfunction
Tear breakup time (TBUT) ≤10 s;
Evidence of meibomian gland (MG) obstruction, based on total MGS of ≤12 in lower eyelids for each eye as assessed by a clinician not involved in the study procedure
Subjective symptom score (using the Standard Patient Evaluation of Eye Dryness [SPEED] questionnaire) ≥10;
At least one meibomian gland opening with a visible plugging over the eyelid margin
No ocular pathology requiring treatment other than eye lubricant and conventional eyelid hygiene within the last month and during the study
The subjects should understand the information provided about the investigative nature of the treatment, possible benefits, and side effects, and sign the Informed Consent Form
The subjects should be willing to comply with the study procedure and schedule, including follow up visits.
Agreement/ability to abstain from dry eye/MGD medications or any device treatments for the time between the treatment visit and the final study visit. Ocular lubricants are allowed if no changes are made during the study.

Exclusion Criteria:

Evidence of co-existing ocular conditions potentially posing an increased risk of procedure-related injury, (e.g., active ocular infection or inflammation in either eye)
History of ocular trauma or surgery including intraocular, oculoplastic, corneal or refractive surgery within 1 year
Ocular surface abnormality potentially compromising corneal integrity in either eye; eyelid abnormalities affecting lid function in either eye
Systemic disease conditions that cause dry eye (e.g., Stevens-Johnson syndrome, vitamin A deficiency, rheumatoid arthritis, Wegener's granulomatosis, sarcoidosis, leukemia, Riley-Day syndrome, systemic lupus erythematosus, Sjogren's syndrome)
Unwillingness to abstain from systemic medications known to cause dryness for the study duration.
Individuals who have either changed the dosing of systemic or non-dry eye/MGD ophthalmic medication within the past 30 days prior to screening
Internal defibrillator, a pacemaker or any other implanted electrical device anywhere in the body
Permanent metal implant in the treatment area
Any surgery in the treatment area in the last 3 months
Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles
Pregnancy and nursing or females of childbearing potential and not utilizing adequate birth control measures
Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications
Patients with a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.
Poorly controlled endocrine disorders, such as diabetes, thyroid dysfunction, polycystic ovary, and hormonal virilization
Any active condition in the treatment area, such as but not limited to open sores, psoriasis, eczema, vitiligo, herpes, and rash.
History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin
Severe concurrent conditions, such as cardiac disorders, sensory disturbances.
Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
Participation in another study within 30 days prior to screening.

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Name	Affiliation	Role
Sean Paul, MD	4316 James Casey St Building F Suite 201, Austin, TX 78745, United States	Principal Investigator
Sandy Zhang-Nunes, MD	Oculofacial Plastic Surgery Director USC Roski Eye Institue USC Keck School of Medicine	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Centennial Eye Associates		Aurora	Colorado	80016	United States
Excellent Vision

ID	Title	Description
FG000	Forma Eye treatment	Forma Eye Applicator: Eligible subjects will receive up to 3 treatments in both eyes (2-3 weeks interval) with the Forma Eye Applicator according to the study protocol. The subject will return for 3 follow up visits: four weeks (4wk FU), 12 weeks (12wk FU), twenty-four weeks (24wk FU) after the last treatment.

ID	Title	Description
BG000	Forma-Eye treatment	Eligible subjects will receive up to 3 treatments in both eyes(2-3 weeks interval) with the Forma Eye Applicator according to the study protocol.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Standardized Patient Evaluation of Eye Dryness (SPEED)

Change dry eye symptoms evaluated by Standardized Patient Evaluation of Eye Dryness (SPEED) This questionnaire gives a score from 0 to 28. Lower score indicates better outcome. 0-4: mild, 5-7: moderate, 8+: severe Scale range: 0 (minimum; no symptoms) to 28 (maximum; most severe symptoms). Interpretation: Lower scores indicate better outcomes. Symptom severity can be categorized as: 0-4 = mild, 5-7 = moderate, 8-28 = severe.

Posted

Mean

Standard Deviation

score on a scale

6 months

ID	Title	Description
OG000	Forma Eye treatment	Forma Eye Applicator: Eligible subjects will receive up to 3 treatments (2-3 weeks interval) with the Forma Eye Applicator according to the study protocol. The subject will return for 3 follow up visits: four weeks (4wk FU), 12 weeks (12wk FU), twenty-four weeks (24wk FU) after the last treatment.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Forma Eye treatment	Forma Eye Applicator: Eligible subjects will receive up to 3 treatments (2-3 weeks interval) with the Forma Eye Applicator according to the study protocol. The subject will return for 3 follow up visits: four weeks (4wk FU), 12 weeks (12wk FU), twenty-four weeks (24wk FU) after the last treatment.