Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
estimated completion

Description

Summary

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.

Official Title

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

Keywords

Open-Angle Glaucoma Ocular Hypertension Bimatoprost DURYSTA Glaucoma Glaucoma, Open-Angle Hypertension Bimatoprost SR Lead-in study ARGOS

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 240196
    La Jolla California 92093 United States
  • Pacific Eye Associates /ID# 240234
    San Francisco California 94115 United States
  • Lakeside Vision Center /ID# 240204
    Irvine California 92604 United States
  • The Eye Research Foundation /ID# 240186
    Newport Beach California 92663-3637 United States
  • Sacramento Eye Consultants /ID# 240263
    Sacramento California 95815 United States
  • Wolstan & Goldberg Eye Associates /ID# 240221
    Torrance California 90505 United States
  • Martel Eye Medical Group /ID# 240291
    Rancho Cordova California 95670-2968 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
Related Info
ID
NCT03891446
Phase
Phase 3 Research Study
Study Type
Interventional
Participants
Expecting 600 study participants
Last Updated