Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-24 @ 12:36 PM
NCT ID:
NCT07039461
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07039461
Study Brief:
Protocol Section:
NCT07039461