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Safety of Tinted Soft Scleral Eye Shields When IPL is Applied on Eyelids

Primary Purpose

Dry Eye Disease, Meibomian Gland Dysfunction

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Protection of eyes with tinted soft scleral eye shields

About this trial

This is an interventional treatment trial for Dry Eye Disease

Eligibility Criteria

22 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject is able to read, understand and sign an IC form
22 or older
Self-assessed symptoms are consistent with dry eye (SPEED score ≥ 10)
Signs of MGD, as detected in biomicroscopy
Fitzpatrick skin type I-V
Subject is willing to comply with all study procedures, including return to the clinic 1 day and 1 week after the first and only treatment within the scope of the study

Exclusion Criteria:

• Fitzpatrick skin type VI
- Ocular surgery or eyelid surgery, within 3 months prior to screening
- Recent ocular trauma, within 3 months prior to screening
- Pre-cancerous lesions, skin cancer or pigmented lesions in the planned treatment area
- Severe active allergies, or other severe uncontrolled eye disorders affecting the ocular surface
- Uncontrolled infections or uncontrolled immunosuppressive diseases
- Subjects with ocular infections requiring the use of antibiotic treatment, within 3 months prior to screening
- Legally blind in either eye
- Ocular surface abnormality that may compromise corneal integrity in either eye (e.g., keratoconus, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, map dot fingerprint dystrophy, prior chemical burn)
- Eyelid abnormalities that affect lid function in either eye, including: entropion, ectropion, tumor, blepharospasm, lagophthalmos, severe trichiasis, and severe ptosis
- Prior history of cold sores or rashes in the perioral area or in the planned treatment area that could be stimulated by light at a wavelength of 560 nm to 1200 nm, including: Herpes simplex 1 & 2, Systemic Lupus erythematosus, and porphyria
- Within 3 months prior to screening, use of photosensitive medication and/or herbs that may cause sensitivity to 560-1200 nm light exposure, including: Isotretinoin, Tetracycline, Doxycycline, and St. John's Wort
- Over exposure to sun, within 4 weeks prior to screening
- Moderate to severely compromised corneal health as assessed by corneal fluorescein staining
- Trans-illumination defects
- Anisocoria or pupil deformation
- Anterior chamber inflammation
- Media opacities (cataract, posterior capsule opacification, corneal edema, etc.) that preclude clear visualization of the anterior segment and retina
- Any condition revealed whereby the investigator deems the subject inappropriate for this study

Sites / Locations

Toyos Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study arm

Arm Description

Protection of eyes with tinted soft scleral eye shields followed by IPL administration directly on eyelids

Outcomes

Primary Outcome Measures

Ophthalmic morphological changes at 1 week after intervention

Opinion of the study investigator (yes/no) whether there was any change in ocular structures at 1 week after intervention (based on a series of tests including biomicroscopy, corneal fluorescein staining, anterior segment OCT, posterior segment OCT, and specular microscopy)

Secondary Outcome Measures

Ophthalmic morphological changes at 10 minutes after intervention

Opinion of the study investigator (yes/no) whether there was any change in ocular structures at 10 minutes after intervention (based on a series of tests including biomicroscopy, corneal fluorescein staining, anterior segment OCT, posterior segment OCT, and specular microscopy)

Ophthalmic morphological changes at 24 hours after intervention

Opinion of the study investigator (yes/no) whether there was any change in ocular structures at 24 hours after intervention (based on a series of tests including biomicroscopy, corneal fluorescein staining, anterior segment OCT, posterior segment OCT, and specular microscopy)

Objective functional change at 10 minutes after intervention

Change in best-corrected visual acuity (ETDRS chart) at 10 minutes after intervention

Objective functional change at 24 hours after intervention

Change in best-corrected visual acuity (ETDRS chart) at 24 hours after intervention

Objective functional change at 1 week after intervention

Change in best-corrected visual acuity (ETDRS chart) at 1 week after intervention

Subjective functional change at 10 minutes after intervention

Change in perception of visual symptoms (Visual analog scale) at 10 minutes after intervention

Subjective functional change at 1 day after intervention

Change in perception of visual symptoms (Visual analog scale) at 1 day after intervention

Subjective functional change at 1 week after intervention

Change in perception of visual symptoms (Visual analog scale) at 1 week after intervention

Full Information

NCT ID

NCT05168670

First Posted

November 25, 2021

Last Updated

May 19, 2022

Sponsor

Lumenis Be Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05168670

Brief Title

Safety of Tinted Soft Scleral Eye Shields When IPL is Applied on Eyelids

Official Title

Safety of Tinted Soft Scleral Eye Shields When IPL is Applied Directly on Eyelids of Subjects With Dry Eye Disease Due to Meibomian Gland Dysfunction

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

December 21, 2021 (Actual)

Primary Completion Date

January 25, 2022 (Actual)

Study Completion Date

January 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lumenis Be Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to verify the safety of tinted soft scleral eye shields when IPL is applied directly on eyelids.

Detailed Description

Patients with dry eye disease due to meibomian gland dysfunction will be treated with one session of IPL applied directly on upper and lower eyelids, when eyes are protected with tinted soft scleral eye shields which prevent IPL from penetrating into ocular structures. Ocular structures will be examined with various tests (including: biomicroscopy, OCT and specular microscopy) at baseline and at 10 minutes after IPL, 24 hours after IPL, and 7 days after IPL. In addition, visual acuity will be measured at each of these times, and the patient will report of any visual symptoms at each of these times. The primary objective is to verify that no morphological or functional changes occur between the baseline and the 7 days follow-up visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye Disease, Meibomian Gland Dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study arm

Arm Type

Experimental

Arm Description

Protection of eyes with tinted soft scleral eye shields followed by IPL administration directly on eyelids

Intervention Type

Combination Product

Intervention Name(s)

Protection of eyes with tinted soft scleral eye shields

Other Intervention Name(s)

IPL adminstration on eyelids

Intervention Description

In subjects with dry eye disease due to meibomian gland dysfunction, protection of eyes with tinted soft scleral eye shields followed by IPL administration on eyelids

Primary Outcome Measure Information:

Title

Ophthalmic morphological changes at 1 week after intervention

Description

Time Frame

1 week

Secondary Outcome Measure Information:

Title

Ophthalmic morphological changes at 10 minutes after intervention

Description

Time Frame

10 minutes

Title

Ophthalmic morphological changes at 24 hours after intervention

Description

Time Frame

24 hours

Title

Objective functional change at 10 minutes after intervention

Description

Change in best-corrected visual acuity (ETDRS chart) at 10 minutes after intervention

Time Frame

10 minutes

Title

Objective functional change at 24 hours after intervention

Description

Change in best-corrected visual acuity (ETDRS chart) at 24 hours after intervention

Time Frame

24 hours

Title

Objective functional change at 1 week after intervention

Description

Change in best-corrected visual acuity (ETDRS chart) at 1 week after intervention

Time Frame

1 week

Title

Subjective functional change at 10 minutes after intervention

Description

Change in perception of visual symptoms (Visual analog scale) at 10 minutes after intervention

Time Frame

10 minutes

Title

Subjective functional change at 1 day after intervention

Description

Change in perception of visual symptoms (Visual analog scale) at 1 day after intervention

Time Frame

1 day

Title

Subjective functional change at 1 week after intervention

Description

Change in perception of visual symptoms (Visual analog scale) at 1 week after intervention

Time Frame

1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject is able to read, understand and sign an IC form 22 or older Self-assessed symptoms are consistent with dry eye (SPEED score ≥ 10) Signs of MGD, as detected in biomicroscopy Fitzpatrick skin type I-V Subject is willing to comply with all study procedures, including return to the clinic 1 day and 1 week after the first and only treatment within the scope of the study Exclusion Criteria: • Fitzpatrick skin type VI Ocular surgery or eyelid surgery, within 3 months prior to screening Recent ocular trauma, within 3 months prior to screening Pre-cancerous lesions, skin cancer or pigmented lesions in the planned treatment area Severe active allergies, or other severe uncontrolled eye disorders affecting the ocular surface Uncontrolled infections or uncontrolled immunosuppressive diseases Subjects with ocular infections requiring the use of antibiotic treatment, within 3 months prior to screening Legally blind in either eye Ocular surface abnormality that may compromise corneal integrity in either eye (e.g., keratoconus, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, map dot fingerprint dystrophy, prior chemical burn) Eyelid abnormalities that affect lid function in either eye, including: entropion, ectropion, tumor, blepharospasm, lagophthalmos, severe trichiasis, and severe ptosis Prior history of cold sores or rashes in the perioral area or in the planned treatment area that could be stimulated by light at a wavelength of 560 nm to 1200 nm, including: Herpes simplex 1 & 2, Systemic Lupus erythematosus, and porphyria Within 3 months prior to screening, use of photosensitive medication and/or herbs that may cause sensitivity to 560-1200 nm light exposure, including: Isotretinoin, Tetracycline, Doxycycline, and St. John's Wort Over exposure to sun, within 4 weeks prior to screening Moderate to severely compromised corneal health as assessed by corneal fluorescein staining Trans-illumination defects Anisocoria or pupil deformation Anterior chamber inflammation Media opacities (cataract, posterior capsule opacification, corneal edema, etc.) that preclude clear visualization of the anterior segment and retina Any condition revealed whereby the investigator deems the subject inappropriate for this study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rolando Toyos, MD

Organizational Affiliation

Toyos Clinic (Nashville, TN, USA)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Toyos Clinic

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37215

Country

United States

12. IPD Sharing Statement

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Safety of Tinted Soft Scleral Eye Shields When IPL is Applied on Eyelids

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