An Extension Trial to Evaluate the Long-term Safety and Efficacy of Bimatoprost SR in Patients With Open Angle Glaucoma or Ocular Hypertension

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT03891446Tipo: INTERVENTIONALInicio: 27 de mar de 2019Fin estimado: 1 de ago de 2026

Traducción no disponible, mostrando original

Resumen

This study will evaluate the long-term safety and efficacy of Bimatoprost Sustained Release (SR) in patients with open-angle glaucoma or ocular hypertension who completed 1 of the 4 Phase 3 Bimatoprost SR studies (192024-091, -092, -093, or -095) and received Bimatoprost SR or who received commercial DURYSTA (Bimatoprost SR) in the open-label Phase 4 ARGOS study (MED-MA-EYE-0648) and completed (or exited early from) the study.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Participants who completed 1 of the 4 Bimatoprost SR Phase 3 studies (192024-091, -092, -093, or -095) and received Bimatoprost SR.
Participants who completed (or exited early from) the open-label Phase 4 ARGOS study with no ongoing safety concerns, and received DURYSTA.

Criterios de exclusión

Female participants who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception during the study.
Concurrent or anticipated enrollment in another investigational drug or device study during the present study.
Any condition which would preclude the participant's ability to comply with study requirements, including completion of the study.
Participants who were randomized to receive timolol eye drops in the study eye (control group) during the Phase 3 Bimatoprost Studies 192024-091 and -092.
For patients from the ARGOS lead-in study: history of prior incisional glaucoma surgeries and/or minimally invasive glaucoma surgical procedures in the study eye or treated fellow eye.

Intervenciones

drug

Bimatoprost SR

Intraocular implant

other

Standard of Care

Standard of care treatment based on investigator's judgement.

Ubicaciones

Consultorio Oftalmologico Dr. Fabian Lerner /ID# 240247

CABA, Buenos Aires, Argentina

Clinica Privada de Ojos /ID# 240272

Mar del Plata, Buenos Aires, Argentina

Hospital Universitario Austral /ID# 240331

Pilar, Buenos Aires, Argentina

Oftalmología Global /ID# 240244

Rosario, Santa Fe Province, Argentina

Oftar Mendoza /ID# 240308

Mendoza, Argentina

Patrocinadores

PrincipalAbbVie

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