Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-27 @ 4:07 PM
Study NCT ID:
NCT07039461
Status:
RECRUITING
Last Update Posted:
2025-09-16
First Post:
2025-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Effectiveness and Safety of Intense Pulsed Light Treatment for Chalazion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017043', 'term': 'Chalazion'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005141', 'term': 'Eyelid Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2025-06-09', 'studyFirstSubmitQcDate': '2025-06-17', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'modified Meibomian Gland Score', 'timeFrame': '4 weeks after the last treatment', 'description': '15 Meibomian glands along the lower lid (5 nasal + 5 central + 5 temporal) will be gently expressed with the dedicated expression forceps. Each gland will be scored 0 to 3, as follows: 0 = clear liquid meibum; 1 = cloudy liquid meibum; 2 = inspissated meibum; 3 = blocked). The modified Meibomian Gland score will be evaluated as the sum of scores for these 15 glands. Hence, the minimal value is 0 (all 15 glands express a clear liquid meibum), and the maximal value is 45 (all 15 glands are blocked). A decrease in the modified Meibomian Gland Score means that the functionality of Meibomian glands improved, and that the condition of the patient improved.'}, {'measure': 'Teat Breakup time', 'timeFrame': '4 weeks after the last treatment', 'description': 'Time between full blink and first appearance of a break in a fluorescein-stained eye'}, {'measure': 'BCVA', 'timeFrame': '4 weeks after the last treatment', 'description': 'Best-corrected visual acuity, using an ETDRS chart (20/20, 20/25, 20/32,20/40,20/50,20/63, 20/80, 20/100, 20/200, 20/400, where 20/20 is considered perfect vision and 20/400 is considered legal blindness)'}, {'measure': 'Adverse events', 'timeFrame': 'Throughout the study and up to 4 weeks after the last treatment', 'description': 'Incidence and type of adverse events'}, {'measure': 'Pain/Discomfort', 'timeFrame': 'day 0, day 7, day 14', 'description': 'Pain/discomfort will be self-reported with a visual analog scale (0 to 10), with 0 representing no pain/discomfort and 10 representing intolerable pain/discomfort.'}, {'measure': 'IOP', 'timeFrame': '4 weeks after the last treatment', 'description': 'intra ocular pressure using tonometer'}, {'measure': 'Biomicroscopy', 'timeFrame': '4 weeks after the last treatment', 'description': 'Eyelid appearance will be assessed with biomicroscopy at the slit lamp'}, {'measure': 'satisfaction level', 'timeFrame': '4 weeks after the last treatment', 'description': 'subject will fill out a satisfaction questionnaire (very satisfied/satisfied/neutral/disappointed/very disappointed).'}], 'primaryOutcomes': [{'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', 'description': 'the proportion of subjects with reduction of at lease 80% in lesion size at the follow up visit'}], 'secondaryOutcomes': [{'measure': 'Percentage change from baseline in lesion size in both groups', 'timeFrame': '4 weeks after the last treatment', 'description': 'measuring the lesion size using a millimeter ruler'}, {'measure': 'Time to resolution which is defined as a reduction of at least 80% in lesion size in both groups', 'timeFrame': '4 weeks after last treatment', 'description': 'measuring the time that takes for a reduction of at least 80% in lesion size'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Chalazion']}, 'descriptionModule': {'briefSummary': 'To study the effectiveness and safety of IPL treatment for Chalazion', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is able to read, understand, and sign an Informed Consent Form (ICF)\n* 18 years of age or older\n* Clinical diagnosis of acute chalazion, present for a maximum of 4 weeks\n* Subject is willing to comply with all study procedures\n\nExclusion Criteria:\n\n* Subjects who underwent IPL treatment less than 6 months prior to screening\n* Concurrent eyelid infection, which to the opinion of the study investigator is not related to the chalazion\n* Chalazion with atypical features, which to the opinion of the study investigator is inadequate for a study\n* Chronic Chalazion\n* Recurring Chalazion\n* Floppy eyelid syndrome\n* Demodex blepharitis patients taking Lotilaner ophthalmic solution within 30 days prior to screening\n* Ocular surgery within 3 months prior to screening\n* Current diagnosis of malignant tumors in the affected eyelid, including: sebaceous carcinoma and basal cell carcinoma\n* Laser Assisted In Situ Keratomileusis (LASIK)/Small Incision Lenticule Extraction (SMILE) surgery, within 1 year prior to screening\n* Radial Keratotomy (RK) surgery\n* Recent ocular trauma, within 3 months prior to screening\n* Pre-cancerous lesions or skin cancer in the planned treatment area\n* Severe active allergies, or other severe uncontrolled eye disorders affecting the ocular surface\n* Uncontrolled infections or uncontrolled immunosuppressive diseases\n* Best corrected visual acuity worse than 20/200 in either eye\n* Ocular surface abnormality that may compromise corneal integrity in either eye (e.g., prior chemical burn, Epithelial Basement Membrane Dystrophy - EBMD)\n* 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\n* Active sun burn in the treatment area\n* Anterior chamber inflammation\n* Corneal edema\n* Any condition revealed whereby the investigator deems the subject inappropriate for this study"}, 'identificationModule': {'nctId': 'NCT07039461', 'briefTitle': 'Evaluation of Effectiveness and Safety of Intense Pulsed Light Treatment for Chalazion', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lumenis Be Ltd.'}, 'officialTitle': 'Evaluation of Effectiveness and Safety of Intense Pulsed Light Treatment for Chalazion', 'orgStudyIdInfo': {'id': 'LUM-VBU-OPT-25-01'}}, 'armsInterventionsModule': {'armGroups': [{'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']}], 'interventions': [{'name': 'OptiLIGHT', 'type': 'DEVICE', 'description': 'three IPL or sham treatment in 1 week interval followed by 1 follow-up 4 weeks after the last treatment', 'armGroupLabels': ['Control arm', 'Study arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10019', 'city': 'New York', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'James Chelnis, MD', 'role': 'CONTACT', 'email': 'drchelnis@manhattanfaceandeye.com'}], 'facility': 'Manhattan Face and Eye clinic', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '98119', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Laura Periman, MD', 'role': 'CONTACT', 'email': 'ClinicalTrials@perimaneyeinstitute.com', 'phone': '2063470821'}, {'name': 'AnaLucia Clarkson', 'role': 'CONTACT', 'email': 'concierge@perimaneyeinstitute.com', 'phone': '+1 (206) 3470821'}], 'facility': 'Periman Eye Institute', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Haya Hamza, Bsc', 'role': 'CONTACT', 'email': 'haya.hamza@lumenis.com', 'phone': '+972527493696'}], 'overallOfficials': [{'name': 'James Chelnis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Manhattan Face and Eye'}, {'name': 'Laura Periman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Periman Eye Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lumenis Be Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}