An Extension Trial to Evaluate the Long-term Safety and Efficacy of Bimatoprost SR inPatients with Open Angle Glaucoma or Ocular Hypertensio

Phase 1

• Conditions: Open-angle Glaucoma and Ocular Hypertension; MedDRA version: 20.0Level: PTClassification code 10030043Term: Ocular hypertensionSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 20.0Level: LLTClassification code 10030856Term: Open-angle glaucomaSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2018-003597-26-DE
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-02
• Last Update Posted: 23 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Written informed consent and authorization for use and release of personal health information are obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Written Authorization for Use and Release of Health and Research Study Information [US sites] and written Data Protection consent [EU) sites])
2. Patient has the ability to understand and willingness to follow study instructions and is likely to complete all required visits and procedures
3. Negative pregnancy test at Screening/Enrollment for females of childbearing potential (as defined in Appendix 6)
4. Patients who completed 1 of the 4 Bimatoprost SR Phase 3 studies (192024-091, -092, -093, or -095) and who were:
a. Not rescued (refers to having received nonstudy IOP-lowering medication[s] or procedure[s] or both, hereafter) in the eye that received Bimatoprost SR, OR
b. Rescued in the eye that received Bimatoprost SR and require additional safety follow-up for that eye based on the investigator’s discretion, OR
c. Rescued in the eye that received Bimatoprost SR and require no additional safety follow-up but have clinically significant implant remnants remaining based on the investigator’s judgment OR
d. Rescued with topical IOP-lowering medications in the eye that received Bimatoprost SR and are eligible for PRN retreatment in the current study (applicable to patients from lead-in Study 192024-093 Stage 2 only; see Table 4-1)
5. Patients who completed (or exited early from) the open-label Phase 4 ARGOS study with no ongoing safety concerns, and who were:
a. Not rescued (refers to having received nonstudy IOP-lowering medication[s] or procedure[s] or both, hereafter ) in the eye that received commercial DURYSTA, OR
b. Rescued with topical IOP-lowering medications in the eye that received commercial DURYSTA and are eligible for PRN retreatment in the current study (see Table 4-1)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

1. Patients who were randomized to receive timolol eye drops in the study eye (control group) during the Phase 3 Bimatoprost Studies 192024-091 and -092
2. Female patients 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 (see Appendix 6)
3. Concurrent or anticipated enrollment in another investigational drug or device study during the present study
4. Any condition which would preclude the patient’s ability to comply with study requirements, including completion of the study
5. Patients who have a condition or are in a situation which, in the investigator’s opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient’s participation in the study.
Note: the investigator should consider a patient's overall health condition, including COVID-19 infection. This should include assessing if the patient is suspected of; quarantined for; or diagnosed with active COVID-19 infection, and whether or not the patient has any symptoms
6. For patients from the ARGOS lead -in study: history of prior incisional glaucoma surgeries in the study eye or treated fellow eye, including (but not limited to) procedures such as: Ahmed Glaucoma Valve, Baerveldt shunt, Ex -Press glaucoma shunt, Molteno shunt, rabeculectomy, etc;
and minimally invasive glaucoma surgical procedures such as (but not limited to): CyPass Micro-Stent, Hydrus, iStent, XEN, et

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified