NCT07405138

Brief Summary

To study the effectiveness and safety of IPL treatment for Chalazion

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Feb 2026Dec 2026

First Submitted

Initial submission to the registry

February 2, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

February 4, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

10 months

First QC Date

February 2, 2026

Last Update Submit

February 17, 2026

Conditions

Chalazion

Outcome Measures

Primary Outcomes (1)

  • The percentage of resolved chalazion 4 weeks after the last treatment in the study group and the control group

    the proportion of subjects with reduction of at lease 80% in lesion size at the follow up visit

    4 weeks after the last treatment

Secondary Outcomes (2)

  • Percentage change from baseline in lesion size in both groups

    4 weeks after the last treatment

  • Time to resolution which is defined as a reduction of at least 80% in lesion size in both groups

    4 weeks after last treatment

Other Outcomes (8)

  • modified Meibomian Gland Score

    4 weeks after the last treatment

  • Teat Breakup time

    4 weeks after the last treatment

  • BCVA

    4 weeks after the last treatment

  • +5 more other outcomes

Study Arms (2)

study arm

EXPERIMENTAL

subjects in the study arm will receive active IPL treatment

Device: Active IPL

Control arm

SHAM COMPARATOR

subjects in the control arm will receive sham IPL treatment

Device: Sham IPL

Interventions

Sham IPLDEVICE

Three sham IPL treatments in 1-week interval followed by 1 follow-up 4 weeks after the last treatment

Control arm
Active IPLDEVICE

Three active IPL treatments in 1-week interval followed by 1 follow-up 4 weeks after the last treatment

study arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is able to read, understand, and sign an Informed Consent Form (ICF)
  • years of age or older
  • Clinical diagnosis of chalazion in the inflammatory stage
  • Subject is willing to comply with all study procedures-

You may not qualify if:

  • Concurrent eyelid infection
  • Chalazion with atypical features, which to the opinion of the study investigator is inadequate for a study
  • Recurring Chalazion
  • Floppy eyelid syndrome
  • Demodex blepharitis patients taking Lotilaner ophthalmic solution within 30 days prior to screening
  • Ocular surgery within 3 months prior to screening
  • Current diagnosis of malignant tumors in the affected eyelid, including:
  • sebaceous carcinoma and basal cell carcinoma
  • Laser Assisted In Situ Keratomileusis (LASIK)/Small Incision Lenticule Extraction (SMILE) surgery, within 1 year prior to screening
  • Radial Keratotomy (RK) surgery
  • Recent ocular trauma, within 3 months prior to screening
  • Pre-cancerous lesions or skin cancer in the planned treatment area
  • Severe active allergies, or other severe uncontrolled eye disorders affecting the ocular surface
  • Uncontrolled infections or uncontrolled immunosuppressive diseases
  • Best corrected visual acuity worse than 20/200 in either eye
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Manhattan Face and Eye clinic

New York, New York, 10019, United States

Location

Periman Eye Institute

Seattle, Washington, 98119, United States

Location

MeSH Terms

Conditions

Chalazion

Condition Hierarchy (Ancestors)

CystsNeoplasmsEyelid DiseasesEye Diseases

Study Officials

  • James Chelnis, MD

    Manhattan Face and Eye clinic

    PRINCIPAL INVESTIGATOR

  • Laura Periman

    Periman Eye Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Haya Hamza, Bsc

CONTACT

+972527493696haya.hamza@lumenis.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized, double masked, controlled study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2026

First Posted

February 12, 2026

Study Start

February 4, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 19, 2026

Record last verified: 2026-02

Locations

US(2)