Evaluation of Effectiveness and Safety of Intense Pulsed Light Treatment for Chalazion

NCT07039461 | Terminated FDA Device

• 1 other identifier: LUM-VBU-OPT-25-01
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

To study the effectiveness and safety of IPL treatment for Chalazion

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

Study Arms (2)

Study arm

EXPERIMENTAL

subjects in the study arm will receive active IPL treatment

Device: OptiLIGHT

Control arm

SHAM COMPARATOR

subjects in the control arm will receive sham IPL treatment

Device: OptiLIGHT

Interventions

OptiLIGHT DEVICE

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

Control arm; Study arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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 acute chalazion, present for a maximum of 4 weeks
• Subject is willing to comply with all study procedures

You may not qualify if:

• Subjects who underwent IPL treatment less than 6 months prior to screening
• Concurrent eyelid infection, which to the opinion of the study investigator is not related to the chalazion
• Chalazion with atypical features, which to the opinion of the study investigator is inadequate for a study
• Chronic Chalazion
• 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

Sponsors & Collaborators

• Lumenis Be Ltd.: lead

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)

Cysts; Neoplasms; Eyelid Diseases; Eye Diseases

Study Officials

• James Chelnis, MD

  Manhattan Face and Eye

  PRINCIPAL INVESTIGATOR

• Laura Periman, MD

  Periman Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 26, 2025
• Study Start: September 12, 2025
• Primary Completion: December 24, 2025
• Study Completion: December 24, 2025
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

US (2)