[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07553455":3,"trial-entities:NCT07553455":83,"trial-summary:NCT07553455":87},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":43,"secondary_outcomes":48,"sex":49,"minimum_age":50,"maximum_age":51,"healthy_volunteers":15,"eligibility_criteria":52,"std_ages":57,"locations":60,"central_contacts":69,"overall_officials":70,"references":71,"see_also_links":82},"NCT07553455","VEV-FLX-2025-01","Vevye + Flarex Combination Therapy for Dry Eye","Combination Therapy of Vevye and Flarex for Dry Eye Disease","ENROLLING_BY_INVITATION","2026-12-31","2026-04","2026-04-28","2026-04-03","Canyon City Eyecare","OTHER",false,"This study evaluates the safety and efficacy of combination therapy with Vevye (cyclosporine ophthalmic solution) and Flarex (fluorometholone acetate ophthalmic suspension) in adults with moderate to severe dry eye disease. Participants receive Vevye twice daily and Flarex four times daily, with outcomes assessed over a 1-month period.","Dry eye disease is a multifactorial disorder characterized by inflammation and tear film instability. Vevye is a cyclosporine formulation designed to enhance ocular surface penetration and tolerability. Flarex is a corticosteroid with a lower risk of intraocular pressure elevation compared to traditional steroids. Combination therapy may accelerate symptom relief and improve tear film stability.\n\nThis prospective, open-label, single-arm study evaluates the clinical outcomes of BID Vevye and QID Flarex over multiple visits, including Screening, Baseline, Day 3, Week 1, and Month 1. Both eyes are treated, with the study eye defined by the worse baseline VAS score.",[19],"Dry Eye",[21,22,23,24,25],"Dry Eye Disease","Ocular Surface Disease","Vevye","Flarex","Fluorometholone","INTERVENTIONAL","TREATMENT",[29],"PHASE4",{"count":31,"type":32},60,"ESTIMATED",[34,40],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DRUG","Vevye(Cyclosporine 0.1% Ophthalmic Solution)","Vevye (cyclosporine ophthalmic solution) is administered twice daily (BID) in both eyes for the treatment of dry eye disease.",[39],"Combination Therapy Arm",{"type":35,"name":24,"description":41,"armGroupLabels":42},"Flarex (fluorometholone acetate ophthalmic suspension) is administered four times daily (QID) in both eyes. Doses are separated from Vevye by approximately 10 minutes.",[39],[44],{"measure":45,"description":46,"timeFrame":47},"VAS","Change in Visual Analog Scale (VAS) Score","Baseline to 1 Month",[],"ALL","18 Years",null,{"inclusion":53,"exclusion":54,"raw_text":56},[],[55],"Uncontrolled systemic disease Ocular surgery\u002Ftrauma within 12 months Punctal plugs \\\u003C6 months Active ocular infection\u002Finflammation Recent lid heating therapy (\\\u003C6 months) Pregnant or breastfeeding Use of topical ocular meds after screening Significant corneal disease Systemic meds causing dry eye (e.g., antihistamines, antidepressants) Intraocular pressure \\>21 mmHg or glaucoma history Contact lens use within 7 days Substance abuse within 12 months","Inclusion Criteria:Adults ≥18 years VAS ≥30 mm (moderate-severe dry eye) Able to provide informed consent Women of childbearing potential must meet contraception requirements\n\n\\-\n\nExclusion Criteria:\n\n* Uncontrolled systemic disease Ocular surgery\u002Ftrauma within 12 months Punctal plugs \\\u003C6 months Active ocular infection\u002Finflammation Recent lid heating therapy (\\\u003C6 months) Pregnant or breastfeeding Use of topical ocular meds after screening Significant corneal disease Systemic meds causing dry eye (e.g., antihistamines, antidepressants) Intraocular pressure \\>21 mmHg or glaucoma history Contact lens use within 7 days Substance abuse within 12 months",[58,59],"ADULT","OLDER_ADULT",[61],{"facility":13,"city":62,"state":63,"zip":64,"country":65,"geoPoint":66},"Azusa","California","91702","United States",{"lat":67,"lon":68},34.13362,-117.90756,[],[],[72,76,79],{"pmid":73,"type":74,"citation":75},"32561483","BACKGROUND","Pflugfelder SC, Stern ME. Biological functions of tear film. Exp Eye Res. 2020 Aug;197:108115. doi: 10.1016\u002Fj.exer.2020.108115. Epub 2020 Jun 16.",{"pmid":77,"type":74,"citation":78},"28736336","Sullivan DA, Rocha EM, Aragona P, Clayton JA, Ding J, Golebiowski B, Hampel U, McDermott AM, Schaumberg DA, Srinivasan S, Versura P, Willcox MDP. TFOS DEWS II Sex, Gender, and Hormones Report. Ocul Surf. 2017 Jul;15(3):284-333. doi: 10.1016\u002Fj.jtos.2017.04.001. Epub 2017 Jul 20.",{"pmid":80,"type":74,"citation":81},"28736335","Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tsubota K, Stapleton F. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017 Jul;15(3):276-283. doi: 10.1016\u002Fj.jtos.2017.05.008. Epub 2017 Jul 20.",[],{"nct_id":4,"conditions":84,"biomarkers":86},[85],"Dry Eye Syndrome",[],{"nct_id":4,"found":15,"summary":51,"prompt_version":51}]