Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT06182358
Status:
COMPLETED
Last Update Posted:
2025-07-02
First Post:
2023-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of XDEMVY® on Demodex Blepharitis in Soft Contact Lens Wearers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Treatment assignment will be unknown to the study participants, investigators, and site staff performing study assessments'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Active arm: XDEMVY 0.25% Control arm: Vehicle of XDEMVY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 145}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-29', 'studyFirstSubmitDate': '2023-12-13', 'studyFirstSubmitQcDate': '2023-12-13', 'lastUpdatePostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of collarettes at Day 43', 'timeFrame': '43 days', 'description': 'Change in collarette score at Day 43 compared to baseline, graded from 0 (0 to 2 lashes have collarettes per eyelid) to 4 ( 2/3 or more of lashes have collarettes per eyelid)'}], 'secondaryOutcomes': [{'measure': 'Reduction of eyelid margin erythema at Day 43', 'timeFrame': '43 days', 'description': 'Change in eyelid margin erythema score at Day 43 compared to baseline, graded from 0 (normal) to 3 (severe)'}, {'measure': 'Subject-reported comfortable daily wear time', 'timeFrame': '43 days', 'description': 'Comfortable daily wear time in hours per day'}, {'measure': 'Total contact lens wear time', 'timeFrame': '43 days', 'description': 'Total daily wear time in hours per day'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Soft contact lenses'], 'conditions': ['Demodex Blepharitis']}, 'descriptionModule': {'briefSummary': 'To compare the efficacy of XDEMVY ophthalmic drop to its vehicle control for the treatment of Demodex blepharitis and its impact on the soft contact lens wearing experience.', 'detailedDescription': 'This Phase 4 study is a prospective, multicenter, randomized, vehicle-controlled, double-masked, two-arm, parallel treatment clinical trial of participants who have Demodex blepharitis and are current daily wear soft contact lenses wearers. The primary outcome measure is the reduction of collarettes at Day 43. The secondary outcome measures are the reduction of eyelid margin erythema at Day 43; subject-reported comfortable contact lens daily wear time; and total contact lens wear time. Safety will be determined by assessing adverse effects related to study drug administration as well as evaluating any clinically significant changes from baseline in visual acuity and slit lamp biomicroscopy findings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be willing to sign the informed consent form and is deemed capable of complying with the requirements of the study protocol\n* Must meet the following criteria in at least one eye: Have more than 10 eyelashes (Grade 2 or higher) with collarettes on the upper or lower eyelid; have at least Grade 1 erythema of the lower eyelid; and have a total meibomian gland secretion score ≥ 12 but ≤ 32 AND have a minimum of 6 expressible glands for the 15 glands evaluated on the lower eyelid\n* Currently wearing soft contact lenses on both eyes an average of at least 2 days per week with an average minimum wearing time of 6 hours each day over the past 3 months and is able and willing to continue to wear contact lenses during the study\n\nExclusion Criteria:\n\n* Use of artificial tears or rewetting drops within 24 hours of the Screening visit or unwilling to forego the use of this treatment during the study\n* Prescription AND systemic, drug delivery implant, ocular topical, or topical: antibacterial, anti-parasitic, or anti-inflammatory corticosteroid treatment within 14 days of the Screening or Day 1 visits\n* Use of TYRVAYA™ Nasal Spray (varenicline solution, Oyster Point Pharma) within 14 days of the Screening visit or unwilling to forego the use of this treatment during the study\n* Use of XDEMVY™ (lotilaner ophthalmic solution) 0.25%, Tarsus Pharmaceuticals, Inc., within 12 months of the Screening visit\n* Treatment for blepharitis (e.g., tea tree oil-based products, hypochlorous acid-based products, commercial eyelid foams, eyelid wipes, lid scrubs, etc.) within 14 days of the Screening visit or unwilling to forego the use of these treatments during the study\n* Use of artificial eyelashes or eyelash extensions at the Screening visit if they limit accurate eyelid margin assessment\n* Currently pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT06182358', 'acronym': 'Ariel', 'briefTitle': 'Impact of XDEMVY® on Demodex Blepharitis in Soft Contact Lens Wearers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tarsus Pharmaceuticals, Inc.'}, 'officialTitle': 'Randomized Controlled Trial to Evaluate the Impact of XDEMVY® on Demodex Blepharitis in Soft Contact Lens Wearers', 'orgStudyIdInfo': {'id': 'TRS-023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Treatment', 'description': 'XDEMVY (lotilaner ophthalmic solution) 0.25%, administered topically twice a day for approximately 43 days', 'interventionNames': ['Drug: Lotilaner ophthalmic solution, 0.25%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Vehicle of XDEMVY ophthalmic solution, administered topically twice a day for approximately 43 days', 'interventionNames': ['Drug: Vehicle control']}], 'interventions': [{'name': 'Lotilaner ophthalmic solution, 0.25%', 'type': 'DRUG', 'description': 'XDEMVY (lotilaner ophthalmic solution) 0.25%, administered topically twice a day for approximately 43 days', 'armGroupLabels': ['Active Treatment']}, {'name': 'Vehicle control', 'type': 'DRUG', 'description': 'Vehicle of XDEMVY administered topically twice a day for approximately 43 days', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85331', 'city': 'Cave Creek', 'state': 'Arizona', 'country': 'United States', 'facility': 'Site', 'geoPoint': {'lat': 33.83333, 'lon': -111.95083}}, {'zip': '90805', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Site', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Vision Institute', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '33484', 'city': 'Delray Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Site', 'geoPoint': {'lat': 26.46146, 'lon': -80.07282}}, {'zip': '46240', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Site', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66762', 'city': 'Pittsburg', 'state': 'Kansas', 'country': 'United States', 'facility': 'Site', 'geoPoint': {'lat': 37.41088, 'lon': -94.70496}}, {'zip': '40206', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Site', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '55436', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Site', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '28150', 'city': 'Shelby', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Site', 'geoPoint': {'lat': 35.29235, 'lon': -81.53565}}, {'zip': '58103', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Site', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '43065', 'city': 'Powell', 'state': 'Ohio', 'country': 'United States', 'facility': 'Site', 'geoPoint': {'lat': 40.15784, 'lon': -83.07519}}, {'zip': '16066', 'city': 'Cranberry Township', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Site', 'geoPoint': {'lat': 40.68496, 'lon': -80.10714}}, {'zip': '38104', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Site', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77005', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Blake Simmons, OD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vision Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tarsus Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}