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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tixel Group | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tixel C | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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), as assessed by a masked rater. TBUT - Tear Break-Up Time, is a clinical test used to evaluate the stability of the tear film on the surface of the eye. It measures the time it takes for dry spots to appear on the cornea after a blink. A shorter TBUT indicates a more unstable tear film, which can be a sign of dry eye disease or other ocular surface disorders. Tear Break-Up Time (TBUT) is typically scored by the time (in seconds). The general interpretation of TBUT scores is as follows: Normal TBUT: More than 10 seconds Borderline TBUT: 5 to 10 seconds Abnormal/Low TBUT: Less than 5 seconds | Tixel arm: Baseline and 4 weeks after last treatment (8 weeks post baseline). LipiFlow arm: Baseline and 4 weeks after treatment (4 weeks post baseline). |
| Comparison of the Incidence of Device-related Ocular Adverse Events | Comparison of the incidence of device-related Ocular adverse events for the two treatment arms | Tixel arm: Baseline to 12 weeks after last treatment (16 weeks post baseline). LipiFlow arm: Baseline to 12 weeks after treatment (12 weeks post baseline). |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Patient OSDI | Change from baseline in patient symptoms using Ocular Surface Disease Index (OSDI) at 4-weeks and 12-weeks follow-up exam. The Ocular Surface Disease Index (OSDI) is a questionnaire designed to assess the severity of dry eye disease. OSDI Questionnaire The questionnaire consists of 12 questions divided into three subscales: Ocular Symptoms Visual Functioning Environmental Triggers Scoring System The scoring for the OSDI is based on a scale from 0 to 100, where higher scores indicate more severe symptoms. Each question is scored as follows: 0: None of the time
Interpretation of OSDI Scores The OSDI scores are generally interpreted as follows: 0-12: Normal or no dry eye 13-22: Mild dry eye 23-32: Moderate dry eye 33-100: Severe dry eye |
| Measure | Description | Time Frame |
|---|---|---|
| Extension Study Endpoint 1 | Durability of the clinical benefit effect at 6-months FU visit assessed by OSDI parameter for a Tixel sub-group population only. | Baseline and 6 months post-last treatment (7 months post-baseline) |
| Extension Study Endpoint 2 |
Main Study (Stage1) Inclusion Criteria:
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:
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:
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
Study Extension (Stage 2)-Exclusion Criteria
* Same as in the main study (stage 1).
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| Name | Affiliation | Role |
|---|---|---|
| Gregg Berdy, MD | Ophthalmology Associates 12990 Manchester Rd., Ste. 200 St. Louis, MO 63131 314-966-3377 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gordon Schanzlin New Vision Institute | La Jolla | California | 92037 | United States | ||
| Visionary Research Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tixel Group | 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. Tixel C: 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 18, 2023 |
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A Randomized, Masked (Evaluator), Controlled, Prospective, open label study.
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Blinded Evaluator
|
| LipiFlow | Device | 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. |
|
| Tixel arm: Baseline to 12 weeks after last treatment (16 weeks post baseline). LipiFlow arm: Baseline to 12 weeks after treatment (12 weeks post baseline). |
| 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), as assessed by a masked rater. BUT - Tear Break-Up Time, is a clinical test used to evaluate the stability of the tear film on the surface of the eye. It measures the time it takes for dry spots to appear on the cornea after a blink. A shorter TBUT indicates a more unstable tear film, which can be a sign of dry eye disease or other ocular surface disorders. Tear Break-Up Time (TBUT) is typically scored by the time (in seconds). The general interpretation of TBUT scores is as follows: Normal TBUT: More than 10 seconds Borderline TBUT: 5 to 10 seconds Abnormal/Low TBUT: Less than 5 seconds | Tixel arm: Baseline and 12 weeks after last treatment (16 weeks post baseline). LipiFlow arm: Baseline and 12 weeks after treatment (12 weeks post baseline). |
| Changes in MGS to 4-weeks and 12-weeks Follow-up Exam | score on a scale at baseline, 4-weeks and 12-weeks follow-up exam in Meibomian Gland (MGS), as assessed by a masked rater. The Meibomian Gland Score (MGS) is a clinical tool used to evaluate the function of the meibomian glands. Scoring Criteria Each gland is assessed and scored based on the quality of the expressed secretion: 0: No secretion
Interpretation of MGS Minimal MGS score = 0 in each eye (15 glands evaluated in each eye) Maximal MGS score = 45 in each eye (15 glands evaluated in each eye) Low MGS: (below 12) Indicates poor function or obstruction of the meibomian glands, suggesting MGD. | Tixel arm: Baseline to 12 weeks after last treatment (16 weeks post baseline). LipiFlow arm: Baseline to 12 weeks after treatment (12 weeks post baseline). |
| Score on a Scale During Treatment Discomfort and Pain Questionnaires (Each Self-assessed by VAS) | Discomfort and Pain from the treatment (Tixel or LipiFlow) using the questionnaires assessed by the subject. These are visual analogue scale (VAS) questionnaires using a scale from 0-10 to assess eye discomfort and pain. Both questionnaires are to be self-assessed by the patient immediately following treatment. Interpetation for the assessment: score 0- no discomfort / pain score 5 - moderate discomfort / pain score 10 - worst possible discomfort / pain | Tixel arm: 4 weeks (treatment 1- day 0, treatment 2- 2 weeks, treatment 3- 4 weeks). LipiFlow arm: On treatment day - day 0 (only one treatment for this arm) |
| Corneal Fluorescein Staining Slit Lamp Evaluation Scores and Change From Baseline | Changes from baseline following treatment for the test and control devices for the following assessments: Ocular Surface Staining (to evaluate the integrity of the corneal epithelium by identifying areas of damage or staining) Grading scale: 0 = Normal - No staining
5 regions (superior, temporal, central, nasal, and inferior) are graded for each eye. total score range from 0 -15. | Tixel arm: Baseline to 12 weeks after last treatment (16 weeks post baseline). LipiFlow arm: Baseline to 12 weeks after treatment (12 weeks post baseline). |
| The Mean Changes From Baseline in IOP for All Eyes on the Tixel and Lipiflow Arms | Changes from baseline following treatment for the test and control devices for: Intraocular Pressure | Tixel arm: Baseline to 12 weeks after last treatment (16 weeks post baseline). LipiFlow arm: Baseline to 12 weeks after treatment (12 weeks post baseline). |
| Ocular Surface Conjunctival Lissamine Green Staining Changes From Baseline | Changes from baseline following treatment for the test and control devices for the following assessments: Lissamine staining scores (to assess the health of the conjunctival and corneal epithelium, particularly in dry eye disease, by identifying areas of damaged or dead cells). Grading scale: 0 = Normal - No staining
6 regions (nasal, superior nasal, inferior nasal, temporal, superior temporal, inferior temporal) are graded for each eye. The total score range for each eye is 0-18. | Tixel arm: Baseline to 12 weeks after last treatment (16 weeks post baseline). LipiFlow arm: Baseline to 12 weeks after treatment (12 weeks post baseline). |
Durability of the clinical benefit effect at 6-months FU visit assessed by TBUT parameter for a Tixel sub-group population only.
| Baseline and 6 months post-last treatment (7 months post-baseline) |
| Extension Study Endpoint 3 | Durability of the clinical benefit effect at 6-months FU visit assessed by MGSS parameter for a Tixel sub-group population only. | Baseline and 6 months post-last treatment (7 months post-baseline) |
| Newport Beach |
| California |
| 92663 |
| United States |
| Moyes Eye Center | Kansas City | Missouri | 64154 | United States |
| Ophthalmology Associates | St Louis | Missouri | 63131 | United States |
| PNV Clinical Research, LLC | Texas City | Texas | 78229 | United States |
| FG001 | LipiFlow | 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. LipiFlow: 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. |
| COMPLETED |
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| NOT COMPLETED |
|
The intent-to-treat (ITT) population includes all randomized subjects. Subjects were analyzed as randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tixel Group | 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. Tixel C: 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. |
| BG001 | LipiFlow | 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. LipiFlow: 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Ftzpatrick skin type | Assessment of subject's skin color was determined prior to study procedure by the Investigator using the FSS. The scale delineates skin color into the categories as shown below : Skin Type Description Type I White skin that never tans and always burns easily Type II White skin that tans slightly and always burns easily Type III Light brown skin that tans gradually and can burn moderately Type IV Moderately brown skin that tans well and burns slightly Type V Dark brown skin that tans profusely and burns rarely Type VI Black skin with deep pigmentation that never burns | Count of Participants | Participants |
|
| 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 | 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), as assessed by a masked rater. TBUT - Tear Break-Up Time, is a clinical test used to evaluate the stability of the tear film on the surface of the eye. It measures the time it takes for dry spots to appear on the cornea after a blink. A shorter TBUT indicates a more unstable tear film, which can be a sign of dry eye disease or other ocular surface disorders. Tear Break-Up Time (TBUT) is typically scored by the time (in seconds). The general interpretation of TBUT scores is as follows: Normal TBUT: More than 10 seconds Borderline TBUT: 5 to 10 seconds Abnormal/Low TBUT: Less than 5 seconds | 48 Tixel subjects and 52 LipiFlow subjects completed the Baseline and 4-week FU TBUT examination. | Posted | Mean | Standard Deviation | seconds | Tixel arm: Baseline and 4 weeks after last treatment (8 weeks post baseline). LipiFlow arm: Baseline and 4 weeks after treatment (4 weeks post baseline). | Eyes | Eyes |
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| Primary | Comparison of the Incidence of Device-related Ocular Adverse Events | Comparison of the incidence of device-related Ocular adverse events for the two treatment arms | Safety Population: Included all subjects who were treated. All safety analyses were performed using the Safety population | Posted | Number | participants | Tixel arm: Baseline to 12 weeks after last treatment (16 weeks post baseline). LipiFlow arm: Baseline to 12 weeks after treatment (12 weeks post baseline). | Eyes | Eyes |
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| Secondary | Changes in Patient OSDI | Change from baseline in patient symptoms using Ocular Surface Disease Index (OSDI) at 4-weeks and 12-weeks follow-up exam. The Ocular Surface Disease Index (OSDI) is a questionnaire designed to assess the severity of dry eye disease. OSDI Questionnaire The questionnaire consists of 12 questions divided into three subscales: Ocular Symptoms Visual Functioning Environmental Triggers Scoring System The scoring for the OSDI is based on a scale from 0 to 100, where higher scores indicate more severe symptoms. Each question is scored as follows: 0: None of the time
Interpretation of OSDI Scores The OSDI scores are generally interpreted as follows: 0-12: Normal or no dry eye 13-22: Mild dry eye 23-32: Moderate dry eye 33-100: Severe dry eye | Per Protocol (PP) Population: Included all subjects who completed all study treatments as randomized, completed the 4-week follow-up visit, and who had no major protocol deviations. The PP population was used for the effectiveness endpoint analyses.Tixel subects and lipiflow subjects completed baseline, 4 weeks OSDI and 12 weeks OSDI. | Posted | Mean | Standard Deviation | score on a scale | Tixel arm: Baseline to 12 weeks after last treatment (16 weeks post baseline). LipiFlow arm: Baseline to 12 weeks after treatment (12 weeks post baseline). | Eyes | Eyes |
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| Secondary | 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), as assessed by a masked rater. BUT - Tear Break-Up Time, is a clinical test used to evaluate the stability of the tear film on the surface of the eye. It measures the time it takes for dry spots to appear on the cornea after a blink. A shorter TBUT indicates a more unstable tear film, which can be a sign of dry eye disease or other ocular surface disorders. Tear Break-Up Time (TBUT) is typically scored by the time (in seconds). The general interpretation of TBUT scores is as follows: Normal TBUT: More than 10 seconds Borderline TBUT: 5 to 10 seconds Abnormal/Low TBUT: Less than 5 seconds | Per Protocol (PP) Population: Included all subjects who completed all study treatments as randomized, completed the 4-week follow-up visit, and who had no major protocol deviations. The PP population was used for the effectiveness endpoint analyses. | Posted | Median | Standard Deviation | seconds | Tixel arm: Baseline and 12 weeks after last treatment (16 weeks post baseline). LipiFlow arm: Baseline and 12 weeks after treatment (12 weeks post baseline). | Eyes | Eyes |
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| Secondary | Changes in MGS to 4-weeks and 12-weeks Follow-up Exam | score on a scale at baseline, 4-weeks and 12-weeks follow-up exam in Meibomian Gland (MGS), as assessed by a masked rater. The Meibomian Gland Score (MGS) is a clinical tool used to evaluate the function of the meibomian glands. Scoring Criteria Each gland is assessed and scored based on the quality of the expressed secretion: 0: No secretion
Interpretation of MGS Minimal MGS score = 0 in each eye (15 glands evaluated in each eye) Maximal MGS score = 45 in each eye (15 glands evaluated in each eye) Low MGS: (below 12) Indicates poor function or obstruction of the meibomian glands, suggesting MGD. | Per Protocol (PP) Population: Included all subjects who completed all study treatments as randomized, completed the 4-week follow-up visit, and who had no major protocol deviations. The PP population was used for the effectiveness endpoint analyses. subject in the tixel group and subject in the lipiflow group comparisoon at baseline, 4 weeks and 12 weeks visits. | Posted | Mean | Standard Deviation | score on a scale | Tixel arm: Baseline to 12 weeks after last treatment (16 weeks post baseline). LipiFlow arm: Baseline to 12 weeks after treatment (12 weeks post baseline). | Eyes | Eyes |
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| Secondary | Score on a Scale During Treatment Discomfort and Pain Questionnaires (Each Self-assessed by VAS) | Discomfort and Pain from the treatment (Tixel or LipiFlow) using the questionnaires assessed by the subject. These are visual analogue scale (VAS) questionnaires using a scale from 0-10 to assess eye discomfort and pain. Both questionnaires are to be self-assessed by the patient immediately following treatment. Interpetation for the assessment: score 0- no discomfort / pain score 5 - moderate discomfort / pain score 10 - worst possible discomfort / pain | Safety Population: Included all subjects who were treated. All safety analyses were performed using the Safety population | Posted | Mean | Standard Deviation | score on a scale | Tixel arm: 4 weeks (treatment 1- day 0, treatment 2- 2 weeks, treatment 3- 4 weeks). LipiFlow arm: On treatment day - day 0 (only one treatment for this arm) | Eyes | Eyes |
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| Secondary | Corneal Fluorescein Staining Slit Lamp Evaluation Scores and Change From Baseline | Changes from baseline following treatment for the test and control devices for the following assessments: Ocular Surface Staining (to evaluate the integrity of the corneal epithelium by identifying areas of damage or staining) Grading scale: 0 = Normal - No staining
5 regions (superior, temporal, central, nasal, and inferior) are graded for each eye. total score range from 0 -15. | Safety Population: Included all subjects who were treated. All safety analyses were performed using the Safety population | Posted | Mean | Standard Deviation | score on a scale | Tixel arm: Baseline to 12 weeks after last treatment (16 weeks post baseline). LipiFlow arm: Baseline to 12 weeks after treatment (12 weeks post baseline). | Eyes | Eyes |
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| Secondary | The Mean Changes From Baseline in IOP for All Eyes on the Tixel and Lipiflow Arms | Changes from baseline following treatment for the test and control devices for: Intraocular Pressure | Safety Population: Included all subjects who were treated. All safety analyses were performed using the Safety population | Posted | Mean | Standard Deviation | score on a scale | Tixel arm: Baseline to 12 weeks after last treatment (16 weeks post baseline). LipiFlow arm: Baseline to 12 weeks after treatment (12 weeks post baseline). | Eyes | Eyes |
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| Secondary | Ocular Surface Conjunctival Lissamine Green Staining Changes From Baseline | Changes from baseline following treatment for the test and control devices for the following assessments: Lissamine staining scores (to assess the health of the conjunctival and corneal epithelium, particularly in dry eye disease, by identifying areas of damaged or dead cells). Grading scale: 0 = Normal - No staining
6 regions (nasal, superior nasal, inferior nasal, temporal, superior temporal, inferior temporal) are graded for each eye. The total score range for each eye is 0-18. | Safety Population: Included all subjects who were treated. All safety analyses were performed using the Safety population | Posted | Mean | Standard Deviation | score on a scale | Tixel arm: Baseline to 12 weeks after last treatment (16 weeks post baseline). LipiFlow arm: Baseline to 12 weeks after treatment (12 weeks post baseline). | Eyes | Eyes |
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| Other Pre-specified | Extension Study Endpoint 1 | Durability of the clinical benefit effect at 6-months FU visit assessed by OSDI parameter for a Tixel sub-group population only. | Tixel sub-group population | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 months post-last treatment (7 months post-baseline) | Eyes | Eyes |
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| Other Pre-specified | Extension Study Endpoint 2 | Durability of the clinical benefit effect at 6-months FU visit assessed by TBUT parameter for a Tixel sub-group population only. | Tixel sub-group population | Posted | Mean | Standard Deviation | seconds | Baseline and 6 months post-last treatment (7 months post-baseline) | Eyes | Eyes |
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| Other Pre-specified | Extension Study Endpoint 3 | Durability of the clinical benefit effect at 6-months FU visit assessed by MGSS parameter for a Tixel sub-group population only. | Tixel sub-group population | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 months post-last treatment (7 months post-baseline) | Eyes | Eyes |
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12 months and 10 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tixel Group | 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. Tixel C: 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. | 0 | 53 | 4 | 53 | 6 | 53 |
| EG001 | LipiFlow | 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. LipiFlow: 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. | 0 | 53 | 1 | 53 | 4 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal Detachment | Eye disorders | MedDRA (10.0) | Systematic Assessment | Retinal detachment |
|
| Operculated Retinal Hole | Eye disorders | MedDRA (10.0) | Systematic Assessment | Retinal tear |
|
| facial melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment | malignant melanoma in situ |
|
| Sepsis | Infections and infestations | MedDRA (10.0) | Systematic Assessment | Sepsis |
|
| Infectious L5/S1 spondylodiscitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment | Intervertebral discitis |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal mass | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | Abdominal mass |
|
| Bronchitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment | Bronchitis |
|
| COVID-19 | Infections and infestations | MedDRA (10.0) | Systematic Assessment | COVID-19 |
|
| Hyprtension | Vascular disorders | MedDRA (10.0) | Systematic Assessment | Hypetension |
|
| Mastoiditis | Infections and infestations | MedDRA (10.0) | Systematic Assessment | Mastoiditis |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (10.0) | Systematic Assessment | Vertigo |
|
| Conjunctival cyst | Eye disorders | MedDRA (10.0) | Systematic Assessment | Conjunctival cyst |
|
| Conjunctivitis allergic | Eye disorders | MedDRA (10.0) | Systematic Assessment | Conjunctivitis allergic |
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| Conjunctivitis viral | Infections and infestations | MedDRA (10.0) | Systematic Assessment | Conjunctivitis viral |
|
| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment | Corneal abrasion |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ifat Klein | Novoxel Ltd | +972-52-6009860 | ifat@novoxel.com |
| Jun 1, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000080343 | Meibomian Gland Dysfunction |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D007766 | Lacrimal Apparatus Diseases |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Type 2 |
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| Type 3 |
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| Type 4 |
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| Type 5 |
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| Type 6 |
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| OG001 | LipiFlow | 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. LipiFlow: 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. |
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| OG001 | LipiFlow | 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. LipiFlow: 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. |
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| OG001 | LipiFlow | 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. LipiFlow: 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. |
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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.
LipiFlow: 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.
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| LipiFlow |
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. LipiFlow: 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. |
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| OG001 | LipiFlow | 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. LipiFlow: 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. |
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