Clinical Efficacy of Two Topical Dry Eye Drops for Central Corneal Stain Clearing Over 90 Days

A Phase 4 Study to Assess the Clinical Efficacy of Nanomicellular Cyclosporine 0.09% Versus Lifitegrast 5.0% for Central Corneal Stain Clearing Over 90 Days

Patrocinadores

Patrocinador principal: Toyos Clinic

Colaborador: Sun Pharmaceutical Industries Limited

Fuente Toyos Clinic
Resumen breve

This study will be a randomized, double-blind prospective in 3 clinical sites to compare the efficacy of two currently approved topical ophthalmic drops in the clearing central corneal staining in 90 days prior to elective cataract or LASIK surgery.

Descripción detallada

The study will be a randomized, double-blind prospective study in 3 sites in the US to compare efficacy of improvement in central corneal staining with fluorescein dye evaluations at slit lamp exam, secondarily improvement in OSDI questionnaire with additional questions regarding dysgeusia, blurriness, and sensation of burning, improvements in corneal topography and improvements in Schirmer's testing. 100 study subjects 18-85 male or female will be enrolled in the Nashville, Beverly Hills and St. Louis areas who are generally healthy with central corneal staining and scheduled for uncomplicated phacoemulsification or uncomplicated LASIK.

Estado general Recruiting
Fecha de inicio February 1, 2020
Fecha de Terminación December 1, 2020
Fecha de finalización primaria May 1, 2020
Fase Phase 4
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
change in central corneal staining 90 days
Resultado secundario
Medida Periodo de tiempo
change in OSDI questionnaire with additional questions of dysgeusia, blurriness and sensation of burning 90 days
change in corneal topography 90 days
change in Schirmers testing 90 days
Inscripción 100
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: nanomicellular cyclosporine 0.09%

Descripción: topical ophthalmic drop prior to elective surgery for eligible patients

Etiqueta de grupo de brazo: Nanomicellular Cyclosporine 0.09 prior to surgery

Otro nombre: Cequa

Tipo de intervención: Drug

Nombre de intervención: Lifitegrast

Descripción: topical ophthalmic drop prior to elective surgery for eligible patients

Etiqueta de grupo de brazo: Lifitegrast 5.0%

Otro nombre: Xiidra

Elegibilidad

Criterios:

Inclusion Criteria:

1. Subject is able to read, understand and sign informed consent.

2. Provision of signed and dated informed consent and HIPAA authorization .

3. Willingness to comply with study procedures and availabilty for duration of study.

4. Aged 18-85, male or female

5. Minimum of 5 central corneal superficial punctate keratitis spots.

6. Normal eyelid anatomy

7. highly effective contraception for at least 1 month prior to screening and agreement to use effective contraception during study participation and for an additional 4 weeks after study drug discontinuation.

8. Postmenopausal or surgical sterilization.

-

Exclusion Criteria:

1. Known hypersensitivity or contraindication to investigational product.

2. Contact lens use within one month prior to screening

3. Unwilling to discontinue contact lens.

4. pregnancy or lactation.

5. topical or nasal vasoconstrictors within 14 days prior to screening or unable to refrain from same.

6. Ocular surgery or eyelid surgery within 6 months prior to screening

7. Subjects can be on the following medications if they have been on a stable dose for 12 weeks: loteprednol, tetracycline, omega 3, anticholinergics, anticonvulsants, antidepressants, retinoids, systemic immunosuppressives including oral steroids, non-steroidals, antihistamines, mast cell stabilizers, punctal plugs, corticotropin repository or glaucoma medications.

8. abstain from eyelast growth products containing prostaglandin

9. Must not have had penetrating intraocular surgery, refractive surgery, cornea transplant, eyelid surgery within 6 months prior to Visit 1

10. Febrile illness within 1 week

11. Treatment with another investigational drug or intervention within one month

12. History of herpetic keratitis.

13. Serious or severe disease or uncontrolled medical condition that in the judgment of the investigator could confound study study assessments or limit compliance.

14. Use of new prescription eyedrop within 90 days of screening.

15. Change in systemic medication within 90 days of screening

16. Anticipated relocation or extensive travel during study period. -

Género: All

Edad mínima: 18 Years

Edad máxima: 85 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Contacto general

Apellido: Rachel McQuiddy

Teléfono: 6153274015

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Copia de seguridad de contactos: Toyos Clinic Rachel McQuiddy 615-327-4015 [email protected]
Ubicacion Paises

United States

Fecha de verificación

March 2020

Fiesta responsable

Tipo: Sponsor

Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Nanomicellular Cyclosporine 0.09 prior to surgery

Tipo: Experimental

Descripción: 50 subjects receive nanomicellular cyclosporien 0.09% prior to elective ophthalmic surgery

Etiqueta: Lifitegrast 5.0%

Tipo: Active Comparator

Descripción: 50 subjects receive liftigrast 5.0% prior to elective ophthalmic surgery

Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Double (Participant, Investigator)

Descripción de enmascaramiento: study medication will be provided in an unmarked box with tape externally covering any identifying language

Fuente: ClinicalTrials.gov