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CompletedNCT05168670Updated May 26, 2022

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

An interventional study of Protection of eyes with tinted soft scleral eye shields in Dry Eye Disease and Meibomian Gland Dysfunction, sponsored by Lumenis Be Ltd.. Completed at 1 site in United States. Open to participants aged 22 Years to 120 Years. Per ClinicalTrials.gov, last updated 2022-05-26.

Sponsored by Lumenis Be Ltd. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
22 Years to 120 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Dry Eye Disease
  • Meibomian Gland Dysfunction
03

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.

This study's enrollment of 20 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Lumenis Be Ltd. is the lead sponsor of 32 studies on the registry; 5 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Study arm

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

    Combination Product: Protection of eyes with tinted soft scleral eye shields

Interventions

  • Combination productProtection of eyes with tinted soft scleral eye shields

    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

    Also known as: IPL adminstration on eyelids

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 1 week

Secondary outcomes

  1. 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)

    Time frame: 10 minutes

  2. 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)

    Time frame: 24 hours

  3. Objective functional change at 10 minutes after intervention

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

    Time frame: 10 minutes

  4. Objective functional change at 24 hours after intervention

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

    Time frame: 24 hours

  5. Objective functional change at 1 week after intervention

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

    Time frame: 1 week

  6. Subjective functional change at 10 minutes after intervention

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

    Time frame: 10 minutes

  7. Subjective functional change at 1 day after intervention

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

    Time frame: 1 day

  8. Subjective functional change at 1 week after intervention

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

    Time frame: 1 week

07

Study locations

1 site
  • Toyos Clinic
    Nashville, Tennessee 37215, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05168670
Lead sponsor
Lumenis Be Ltd.
Responsible party
Sponsor
First posted
Dec 23, 2021
Start date
Dec 21, 2021
Primary completion
Jan 25, 2022
Completion
Jan 25, 2022
Last update
May 26, 2022

Study contacts

Rolando Toyos, MD
principal investigator · Toyos Clinic (Nashville, TN, USA)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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