to Evaluate the Effectiveness and Safety of the Tixel® , VS LipiFlow® in the Treatment of Meibomian Gland Dysfunction
Primary Purpose
Meibomian Gland Dysfunction, Dry Eye Syndromes, Dry Eye
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tixel C
LipiFlow
Sponsored by
About this trial
This is an interventional treatment trial for Meibomian Gland Dysfunction
Eligibility Criteria
Inclusion Criteria:
- Age 22 years and older of any gender or race.
- Provision of written informed consent prior to study participation.
- Willingness and ability to return for all study visits.
- Reports dry eye symptoms for three months prior to the study.
- Ocular Surface Disease Index (OSDI) score between 23-79.
- Tear break-up time (TBUT) <10 seconds in both eyes.
- Agreement/ability to abstain from dry eye/MGD medications for the time between the treatment visit/s and the final study visit. Ocular lubricants are allowed if no changes are made during the study.
- Reports having to use artificial tears or lubricants regulatory over the past month to relieve dry eye symptoms.
- Meibomian gland obstruction in both eyes based on a total Meibomian Gland Secretion Score ≤12 in each eye.
- At least 15 glands in each lower eyelid should be expressible, with a sterile cotton swab, at the slit lamp.
Exclusion Criteria:
- History of ocular surgery including intraocular, oculo-plastic, corneal or refractive surgery within 6 months.
- Patient with giant papillary conjunctivitis.
- Patient with punctal plugs or who have had punctal cautery.
- Ocular injury or trauma, chemical burns, or limbal stem cell deficiency within 3 months of the baseline examination.
- Active ocular herpes zoster or simplex of eye or eyelid or a history of these any time.
- Patient who are aphakic.
- Cicatricial lid margin disease identified via slit lamp examination, including pemphigoid, symblepharon, etc.
- Active ocular infection (e.g., viral, bacterial, mycobacterial, protozoan, or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac, or eyelids including a hordeolum or stye).
- Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months (e.g., retinitis, macular inflammation, choroiditis, uveitis, iritis, scleritis, episcleritis, keratitis).
- Ocular surface abnormality that may compromise corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy).
- Lid surface abnormalities (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis) that affect lid function in either eye.
- Anterior blepharitis (staphylococcal, demodex or seborrheic grade 3 or 4).
- 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).
Use of any of the following medications:
- Systemic medication(s) that is known to cause ocular dryness (e.g. antihistamine, diuretics, anti-hypertensives, anti-depressants, hormone therapy) whose dose of this medication(s) has not been stable within 30 days prior to enrolment. There must be no anticipated adjustments to the dose of these medications for the duration of the trial;
- Oral tetracyclines or azithromycin within 30 days prior to enrolment; or
- Topical anti-glaucoma medications within 30 days prior to enrolment.
- Any other systemic medication as per to the Investigator's discretion.
- Women in childbearing age who are pregnant, nursing, or not utilizing adequate birth control measures.
- Individuals using isotretinoin (Accutane) within 1 year, cyclosporine-A (Restasis) or lifitegrast ophthalmic solution (Xiidra) within 45 days prior to study treatment (day 0), or any other dry eye or MGD medications (antibiotics, non-steroidal anti-inflammatory drugs, corticosteroids) for at least 2 weeks and to maintain abstinence throughout the duration of the study (ocular lubricants are allowed if no changes are made during the study).
- Individuals wearing contact lenses 1 month prior study treatment (day 0), and at any point during the study.
- Current skin cancer, malignant sites and/or advanced premalignant lesions or moles in the treatment area.
- An impaired immune system condition or use of immunosuppressive medication.
- Collagen disorders, keloid formation and/or abnormal wound healing.
- Previous invasive/ablative procedures in the areas to be treated within 3 months prior to initial treatment or plans for such treatment during the course treatment, or before complete healing of such treatments has occurred.
- Any patient who takes or has taken any oral or topical medications, such as but not limited to topical retinoid (e.g., Retin-A), chemical peels, Latisse, Lash Boost which may cause fragile skin or impaired skin healing in the treatment area during the last 3 months and in the entire study period.
- Any patient who has a history of bleeding coagulopathies.
- Any patient who has tattoos or permanent makeup in the treated area.
- Any patient who has burned, blistered, irritated, or sensitive skin in any of the areas to be treated.
- Individuals using another ophthalmic investigational device or agent within 30 days of study participation.
Any of the following dry eye treatments:
- Office-based dry eye treatment (e.g. IPL, LipiFlow, iLux, TearCare, Tixel, etc.) within 12 months prior to enrolment;
- Meibomian gland expression within 6 months prior to enrolment;
- Blephex or debridement within 3 months prior to enrollment is an exclusion;
- Punctal occlusion or punctal plug placement within 30 days prior to enrolment;
- Use of iTear or TrueTear device within the past 2 weeks. (Subjects must refrain from using these devices for the duration of the study.); or
- Any history of meibomian gland probing
- Use of at-home warm compresses or lid hygiene products while participating in study.
- IOP higher than 19 mmHg.
- Use of Botulinum-Toxin in the last 6 months prior to the treatment in the treatment area.
- Any co-existing condition, either ocular or non-ocular that, in the judgement of the investigator, could affect the safety or effectiveness of treatment or the compliance of the subject to the protocol.
Sites / Locations
- Gordon Schanzlin New Vision Institute
- Visionary Research Institute
- Moyes Eye Center
- Ophthalmology Associates
- PNV Clinical Research, LLC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tixel Group
LipiFlow
Arm Description
Screening and baseline visits, Treatment- 3 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after the last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire.
LipiFlow: Screening and baseline visits,Treatment session, followed by 2 Follow up sessions, 1and 3 months after the last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire.
Outcomes
Primary Outcome Measures
Changes in Tear Break Up Times (TBUT) to the 4-weeks follow-up exam
Change from baseline to the 4-weeks follow-up exam in Tear Break Up Times (TBUT)
Comparison of the incidence of device-related Ocular adverse events
Comparison of the incidence of device-relatedOcular adverse events for the two treatment arms
Secondary Outcome Measures
Changes in patient OSDI
Changes from baseline in patient symptoms using Ocular Surface Disease Index (OSDI) at 4-weeks and 12-weeks follow-up exam.
OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability.
A patient's score between 1-12 is defined as normal, A patient's score between 13 - 22 is defined as mild, A patient's score between 23 - 32 is defined as moderate, and a patient's score between 33 - 100 is defined as severe dry eye diseases.
Changes in Tear Break Up Times (TBUT) to the 12-weeks follow-up exam
Changes from baseline to the 12-weeks follow-up exam in Tear Break Up Times (TBUT)
Changes in MGS to 4-weeks and 12-weeks follow-up exam
Change from baseline to 4-weeks and 12-weeks follow-up exam in Meibomian Gland Score (MGS).
Safety Endpoint - Adverse events
The evaluation of discomfort and pain during treatment.(VAS score of 1-10)
Ocular Surface Staining changes
Changes from baseline following treatment for the test and control devices for the Ocular Surface Staining
Intraocular Pressure changes
Changes from baseline following treatment for the test and control devices for:
Intraocular Pressure
Best corrected distance Visual acuity changes
Changes from baseline following treatment for the test and control devices for Best corrected distance Visual acuity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05162261
Brief Title
to Evaluate the Effectiveness and Safety of the Tixel® , VS LipiFlow® in the Treatment of Meibomian Gland Dysfunction
Official Title
A Randomized, Masked (Evaluator), Controlled, Prospective Study Evaluating the Effectiveness and Safety of the Tixel® Medical Device, Versus LipiFlow® in the Treatment of Meibomian Gland Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 19, 2022 (Actual)
Primary Completion Date
April 26, 2023 (Actual)
Study Completion Date
September 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novoxel Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
A Randomized, Masked (Evaluator), Controlled, Prospective Study Evaluating the Effectiveness and Safety of the Tixel® Medical Device, Versus LipiFlow® in the Treatment of Meibomian Gland Dysfunction
Detailed Description
Randomized, open-label study comparing the Tixel device to LipiFlow System. Up to 110 patients (220 eyes) to be randomized in up to 5 clinical sites in the United States.
Evaluators will be masked as to the randomization assignments. Both eyes will receive the same randomized assignment and both eyes of each patient will be evaluated at all time points.
Data from both eyes will be using in the statistical analysis. The random-effects model adjusts the standard error (SE) and the confidence interval (CI) for within-person correlation between eyes.
Protocol Rev. 7.0 update: Addition of protocol extension to the current protocol: stage 1- main protocol for all patients and stage 2- extension protocol to a sub-group of patients only in the Tixel arm for additional follow-up visit 6 months post last treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction, Dry Eye Syndromes, Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Randomized, Masked (Evaluator), Controlled, Prospective, open label study.
Masking
Outcomes Assessor
Masking Description
Blinded Evaluator
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tixel Group
Arm Type
Experimental
Arm Description
Screening and baseline visits, Treatment- 3 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after the last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire.
Arm Title
LipiFlow
Arm Type
Active Comparator
Arm Description
LipiFlow: Screening and baseline visits,Treatment session, followed by 2 Follow up sessions, 1and 3 months after the last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire.
Intervention Type
Device
Intervention Name(s)
Tixel C
Intervention Description
Tixel C by 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.
Intervention Type
Device
Intervention Name(s)
LipiFlow
Intervention Description
Thermal pulsation (LipiFlow) consists of the localized application of heat and therapeutic pressure on the four eyelids (upper and lower) with the aim of improving drainage of the Meibomian glands.
Primary Outcome Measure Information:
Title
Changes in Tear Break Up Times (TBUT) to the 4-weeks follow-up exam
Description
Change from baseline to the 4-weeks follow-up exam in Tear Break Up Times (TBUT)
Time Frame
Up to 18 months include Follow up visits.
Title
Comparison of the incidence of device-related Ocular adverse events
Description
Comparison of the incidence of device-relatedOcular adverse events for the two treatment arms
Time Frame
Up to 18 months include Follow up visits.
Secondary Outcome Measure Information:
Title
Changes in patient OSDI
Description
Changes from baseline in patient symptoms using Ocular Surface Disease Index (OSDI) at 4-weeks and 12-weeks follow-up exam.
OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability.
A patient's score between 1-12 is defined as normal, A patient's score between 13 - 22 is defined as mild, A patient's score between 23 - 32 is defined as moderate, and a patient's score between 33 - 100 is defined as severe dry eye diseases.
Time Frame
Up to 18 months include Follow up visits.
Title
Changes in Tear Break Up Times (TBUT) to the 12-weeks follow-up exam
Description
Changes from baseline to the 12-weeks follow-up exam in Tear Break Up Times (TBUT)
Time Frame
Up to 18 months include Follow up visits.
Title
Changes in MGS to 4-weeks and 12-weeks follow-up exam
Description
Change from baseline to 4-weeks and 12-weeks follow-up exam in Meibomian Gland Score (MGS).
Time Frame
Up to 18 months include Follow up visits.
Title
Safety Endpoint - Adverse events
Description
The evaluation of discomfort and pain during treatment.(VAS score of 1-10)
Time Frame
Up to 18 months include Follow up visits.
Title
Ocular Surface Staining changes
Description
Changes from baseline following treatment for the test and control devices for the Ocular Surface Staining
Time Frame
Up to 18 months include Follow up visits.
Title
Intraocular Pressure changes
Description
Changes from baseline following treatment for the test and control devices for:
Intraocular Pressure
Time Frame
Up to 18 months include Follow up visits.
Title
Best corrected distance Visual acuity changes
Description
Changes from baseline following treatment for the test and control devices for Best corrected distance Visual acuity
Time Frame
Up to 18 months include Follow up visits.
Other Pre-specified Outcome Measures:
Title
Extension study endpoint 1
Description
Durability of the clinical benefit effect at 6-months FU visit assessed by OSDI parameter
Time Frame
Additional 3 months study participation on top of Main Study 18 months duration
Title
Extension study endpoint 2
Description
Durability of the clinical benefit effect at 6-months FU visit assessed by TBUT parameter
Time Frame
Additional 3 months study participation on top of Main Study 18 months duration
Title
Extension study endpoint 3
Description
Durability of the clinical benefit effect at 6-months FU visit assessed by MGSS parameter
Time Frame
Additional 3 months study participation on top of Main Study 18 months duration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Study (Stage1) Inclusion Criteria:
Age 22 years and older of any gender or race.
Provision of written informed consent prior to study participation.
Willingness and ability to return for all study visits.
Reports dry eye symptoms for three months prior to the study.
Ocular Surface Disease Index (OSDI) score between 23-79.
Tear break-up time (TBUT) <10 seconds in both eyes.
Agreement/ability to abstain from dry eye/MGD medications for the time between the treatment visit/s and the final study visit. Ocular lubricants are allowed if no changes are made during the study.
Reports having to use artificial tears or lubricants regulatory over the past month to relieve dry eye symptoms.
Meibomian gland obstruction in both eyes based on a total Meibomian Gland Secretion Score ≤12 in each eye.
At least 15 glands in each lower eyelid should be expressible, with a sterile cotton swab, at the slit lamp.
Main Study (Stage1) Exclusion Criteria:
History of ocular surgery including intraocular, oculo-plastic, corneal or refractive surgery within 6 months.
Patient with giant papillary conjunctivitis.
Patient with punctal plugs or who have had punctal cautery.
Ocular injury or trauma, chemical burns, or limbal stem cell deficiency within 3 months of the baseline examination.
Active ocular herpes zoster or simplex of eye or eyelid or a history of these any time.
Patient who are aphakic.
Cicatricial lid margin disease identified via slit lamp examination, including pemphigoid, symblepharon, etc.
Active ocular infection (e.g., viral, bacterial, mycobacterial, protozoan, or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac, or eyelids including a hordeolum or stye).
Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months (e.g., retinitis, macular inflammation, choroiditis, uveitis, iritis, scleritis, episcleritis, keratitis).
Ocular surface abnormality that may compromise corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy).
Lid surface abnormalities (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis) that affect lid function in either eye.
Anterior blepharitis (staphylococcal, demodex or seborrheic grade 3 or 4).
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).
Use of any of the following medications:
Systemic medication(s) that is known to cause ocular dryness (e.g. antihistamine, diuretics, anti-hypertensives, anti-depressants, hormone therapy) whose dose of this medication(s) has not been stable within 30 days prior to enrolment. There must be no anticipated adjustments to the dose of these medications for the duration of the trial;
Oral tetracyclines or azithromycin within 30 days prior to enrolment; or
Topical anti-glaucoma medications within 30 days prior to enrolment.
Any other systemic medication as per to the Investigator's discretion.
Women in childbearing age who are pregnant, nursing, or not utilizing adequate birth control measures.
Individuals using isotretinoin (Accutane) within 1 year, cyclosporine-A (Restasis) or lifitegrast ophthalmic solution (Xiidra) within 45 days prior to study treatment (day 0), or any other dry eye or MGD medications (antibiotics, non-steroidal anti-inflammatory drugs, corticosteroids) for at least 2 weeks and to maintain abstinence throughout the duration of the study (ocular lubricants are allowed if no changes are made during the study).
Individuals wearing contact lenses 1 month prior study treatment (day 0), and at any point during the study.
Current skin cancer, malignant sites and/or advanced premalignant lesions or moles in the treatment area.
An impaired immune system condition or use of immunosuppressive medication.
Collagen disorders, keloid formation and/or abnormal wound healing.
Previous invasive/ablative procedures in the areas to be treated within 3 months prior to initial treatment or plans for such treatment during the course treatment, or before complete healing of such treatments has occurred.
Any patient who takes or has taken any oral or topical medications, such as but not limited to topical retinoid (e.g., Retin-A), chemical peels, Latisse, Lash Boost which may cause fragile skin or impaired skin healing in the treatment area during the last 3 months and in the entire study period.
Any patient who has a history of bleeding coagulopathies.
Any patient who has tattoos or permanent makeup in the treated area.
Any patient who has burned, blistered, irritated, or sensitive skin in any of the areas to be treated.
Individuals using another ophthalmic investigational device or agent within 30 days of study participation.
Any of the following dry eye treatments:
Office-based dry eye treatment (e.g. IPL, LipiFlow, iLux, TearCare, Tixel, etc.) within 12 months prior to enrolment;
Meibomian gland expression within 6 months prior to enrolment;
Blephex or debridement within 3 months prior to enrollment is an exclusion;
Punctal occlusion or punctal plug placement within 30 days prior to enrolment;
Use of iTear or TrueTear device within the past 2 weeks. (Subjects must refrain from using these devices for the duration of the study.); or
Any history of meibomian gland probing
Use of at-home warm compresses or lid hygiene products while participating in study.
IOP higher than 19 mmHg.
Use of Botulinum-Toxin in the last 6 months prior to the treatment in the treatment area.
Any co-existing condition, either ocular or non-ocular that, in the judgement of the investigator, could affect the safety or effectiveness of treatment or the compliance of the subject to the protocol.
Study Extension (Stage 2)- Inclusion Criteria
Subjects who have completed the main study CLN 0858 (stage 1) in the Tixel arm.
TBUT -change from baseline in 1-month FU or 3-months FU was 2.5 seconds or above at least in one eye in the main study.
Provision of written informed consent for stage 2.
Agreement/ability to abstain from dry eye/MGD medications for the time in the extension study. Ocular lubricants are allowed if no changes are made during the study.
Study Extension (Stage 2)-Exclusion Criteria
* Same as in the main study (stage 1).
Facility Information:
Facility Name
Gordon Schanzlin New Vision Institute
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Visionary Research Institute
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Moyes Eye Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64154
Country
United States
Facility Name
Ophthalmology Associates
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
PNV Clinical Research, LLC
City
Texas City
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
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to Evaluate the Effectiveness and Safety of the Tixel® , VS LipiFlow® in the Treatment of Meibomian Gland Dysfunction
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