This study is in progress, not accepting new patients

Long-term Safety and Efficacy Extension Trial of Bimatoprost SR

a study on Glaucoma High Blood Pressure Ocular Hypertension

Summary

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

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, Standard of Care, 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 5363943 California 5332921 92093 United States
  • Pacific Eye Associates /ID# 240234
    San Francisco 5391959 California 5332921 94115 United States
  • Angeles Eye Institute /ID# 250397
    Culver City 5341114 California 5332921 90232 United States
  • Duplicate_Lakeside Vision Center /ID# 240204
    Irvine 5359777 California 5332921 92604 United States
  • The Eye Research Foundation /ID# 240186
    Newport Beach 5376890 California 5332921 92663-3637 United States
  • Wolstan & Goldberg Eye Associates /ID# 240221
    Torrance 5403022 California 5332921 90505 United States
  • Sacramento Eye Consultants /ID# 240263
    Sacramento 5389489 California 5332921 95815 United States
  • Duplicate_Martel Eye Medical Group /ID# 240291
    Rancho Cordova 5385941 California 5332921 95670-2968 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
Related Info
ID
NCT03891446
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 455 people participating
Last Updated