Clinical trial · Interventional
Evaluation of Effectiveness and Safety of Intense Pulsed Light Treatment for Chalazion
NCT07039461CI-TRIAL-00100159terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): identification of several protocol deviations that may affect the primary outcome accuracy
Summary
Brief summary (as posted)
To study the effectiveness and safety of IPL treatment for Chalazion
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chalazion | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OptiLIGHT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Study arm
- description
- subjects in the study arm will receive active IPL treatment
- interventionNames
- Device: OptiLIGHT
- type
- SHAM_COMPARATOR
- label
- Control arm
- description
- subjects in the control arm will receive sham IPL treatment
- interventionNames
- Device: OptiLIGHT
Primary outcomes (1)
- measure
- The percentage of resolved chalazion 4 weeks after the last treatment in the study group and the control group
- timeFrame
- 4 weeks after the last treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
References
Publications (0)
Data not yet available
No reference posted for this study.