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| ID | Type | Description | Link |
|---|---|---|---|
| 15573-MMHom | Other Identifier | Sterling IRB |
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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.
This 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination Therapy Arm | Experimental | Participants receive Vevye (cyclosporine ophthalmic solution) twice daily and Flarex (fluorometholone acetate ophthalmic suspension) four times daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vevye(Cyclosporine 0.1% Ophthalmic Solution) | Drug | Vevye (cyclosporine ophthalmic solution) is administered twice daily (BID) in both eyes for the treatment of dry eye disease. |
|
| Measure | Description | Time Frame |
|---|---|---|
| VAS | Change in Visual Analog Scale (VAS) Score | Baseline to 1 Month |
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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
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canyon City Eyecare | Azusa | California | 91702 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32561483 | Background | Pflugfelder SC, Stern ME. Biological functions of tear film. Exp Eye Res. 2020 Aug;197:108115. doi: 10.1016/j.exer.2020.108115. Epub 2020 Jun 16. | |
| 28736336 | Background | 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/j.jtos.2017.04.001. Epub 2017 Jul 20. |
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Individual participant data will not be shared.
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D009883 | Ophthalmic Solutions |
| D005469 | Fluorometholone |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
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| Flarex | Drug | Flarex (fluorometholone acetate ophthalmic suspension) is administered four times daily (QID) in both eyes. Doses are separated from Vevye by approximately 10 minutes. |
|
| 28736335 | Background | 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/j.jtos.2017.05.008. Epub 2017 Jul 20. |
| D020228 |
| Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |