Chalazion
Conditions
Brief summary
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
Interventions
DEVICESham IPL
Three sham IPL treatments in 1-week interval followed by 1 follow-up 4 weeks after the last treatment
DEVICEActive IPL
Three active IPL treatments in 1-week interval followed by 1 follow-up 4 weeks after the last treatment
Sponsors
Lumenis Be Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
randomized, double masked, controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is able to read, understand, and sign an Informed Consent Form (ICF) * 18 years of age or older * Clinical diagnosis of chalazion in the inflammatory stage * Subject is willing to comply with all study procedures-
Exclusion criteria
* 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 * Ocular surface abnormality that may compromise corneal integrity in either eye (e.g., prior chemical burn, Epithelial Basement Membrane Dystrophy - EBMD) * Within 1 week 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 w
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of resolved chalazion 4 weeks after the last treatment in the study group and the control group | 4 weeks after the last treatment | the proportion of subjects with reduction of at lease 80% in lesion size at the follow up visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change from baseline in lesion size in both groups | 4 weeks after the last treatment | measuring the lesion size using a millimeter caliper |
| Time to resolution which is defined as a reduction of at least 80% in lesion size in both groups | 4 weeks after last treatment | measuring the time that takes for a reduction of at least 80% in lesion size |
Countries
United States
Contacts
CONTACTHaya Hamza, Bsc
PRINCIPAL_INVESTIGATORJames Chelnis, MD
Manhattan Face and Eye clinic
PRINCIPAL_INVESTIGATORLaura Periman
Periman Eye Institute
Outcome results
None listed