ChalazionNCT07039461
Evaluation of Effectiveness and Safety of Intense Pulsed Light Treatment for Chalazion
A study testing OptiLIGHT in people with Chalazion, run by Lumenis Be Ltd. at 2 sites in United States.
Trial summary
To study the effectiveness and safety of IPL treatment for Chalazion Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chalazion
- What is being tested?
- OptiLIGHT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Sep 2025to 24 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is able to read, understand, and sign an Informed Consent Form (ICF)
- 18 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
Who cannot join
- 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
Show all 22Show fewer
- 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
- Ocular surface abnormality that may compromise corneal integrity in either eye (e.g., prior chemical burn, Epithelial Basement Membrane Dystrophy - EBMD)
- 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
- Active sun burn in the treatment area
- Anterior chamber inflammation
- Corneal edema
- Any condition revealed whereby the investigator deems the subject inappropriate for this study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Manhattan Face and Eye clinic
New York, New York, 10019
Periman Eye Institute
Seattle, Washington, 98119
About this study
To study the effectiveness and safety of IPL treatment for Chalazion
Read the detailed description
The study aims to evaluate the effectiveness and safety of IPL therapy for the treatment of chalazion. The effect of IPL on chalazion will be examined in a masked randomized controlled study. Subjects in the study arm will be treated with IPL, while subjects in the control arm will be treated with sham IPL. A significant difference in the outcomes of the two arms will provide support for a genuine contribution of the IPL treatment
- Conditions
- Chalazion
- Being tested
- OptiLIGHT
- Medical subject headings
- Chalazion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OptiLIGHTDevice
three IPL or sham treatment in 1 week interval followed by 1 follow-up 4 weeks after the last treatment
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | subjects in the study arm will receive active IPL treatment Receives: Device: OptiLIGHT |
| Control arm | Sham comparator | subjects in the control arm will receive sham IPL treatment Receives: Device: OptiLIGHT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks after the last treatment
Secondary outcomes (2)
Percentage change from baseline in lesion size in both groups
measuring the lesion size using a millimeter ruler
Measured: 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
measuring the time that takes for a reduction of at least 80% in lesion size
Measured: 4 weeks after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start12 Sep 2025
- Primary completion24 Dec 2025
- Study completion24 Dec 2025
Why it stopped: identification of several protocol deviations that may affect the primary outcome accuracy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChalazionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumenis Be Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Chelnis, MD, Principal investigator, Manhattan Face and EyeLaura Periman, MD, Principal investigator, Periman Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039461
- Sponsor's protocol ID
- LUM-VBU-OPT-25-01
- Status last verified
- Jan 2026
- First submitted
- 9 Jun 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness and Safety of Intense Pulsed Light Treatment for Chalazion
- ClinicalTrials.gov ID
- NCT07039461
- Acronym / sponsor ID
- LUM-VBU-OPT-25-01
- Conditions
- Chalazion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: identification of several protocol deviations that may affect the primary outcome accuracy
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Lumenis Be Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- 24 Dec 2025 (actual)
- Study completion
- 24 Dec 2025 (actual)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the effectiveness and safety of IPL treatment for Chalazion
Detailed description
The study aims to evaluate the effectiveness and safety of IPL therapy for the treatment of chalazion. The effect of IPL on chalazion will be examined in a masked randomized controlled study. Subjects in the study arm will be treated with IPL, while subjects in the control arm will be treated with sham IPL. A significant difference in the outcomes of the two arms will provide support for a genuine contribution of the IPL treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Device: OptiLIGHTsubjects in the study arm will receive active IPL treatment |
| Control arm | Sham comparator | Device: OptiLIGHTsubjects in the control arm will receive sham IPL treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is able to read, understand, and sign an Informed Consent Form (ICF)
- 18 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OptiLIGHTthree IPL or sham treatment in 1 week interval followed by 1 follow-up 4 weeks after the last treatment | Device | Control arm, Study arm |
Primary outcome
The percentage of resolved chalazion 4 weeks after the last treatment in the study group and the control group
Time frame: 4 weeks after the last treatment
the proportion of subjects with reduction of at lease 80% in lesion size at the follow up visit
2 secondary outcomes
Percentage change from baseline in lesion size in both groups
Time frame: 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
Time frame: 4 weeks after last treatment
Results and safety
The study was stopped early (reason given: identification of several protocol deviations that may affect the primary outcome accuracy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
Related trials for Chalazion
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Omega-3 Supplementation vs Demodex vs Eyelid Cleanser for Pediatric Chalazia
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Is the Use of a Steam Mask an Effective Treatment for Paediatric Chalazion in Comparison to Traditional Warm Compresses?
Chalazion
Not yet recruiting
Evaluation of Effectiveness and Safety of Intense Pulsed Light Treatment for Chalazion
Chalazion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Chelnis, MD principal investigator
Manhattan Face and Eye
Laura Periman, MD principal investigator
Periman Eye Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OptiLIGHT in people with Chalazion, run by Lumenis Be Ltd. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: identification of several protocol deviations that may affect the primary outcome accuracy). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of resolved chalazion 4 weeks after the last treatment in the study group and the control group (time frame: 4 weeks after the last treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.