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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504601-36-00
Acronym
1698-302-007
Enrollment
28
Registered
2023-11-24
Start date
2019-11-20
Completion date
2025-04-10
Last updated
2025-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open-angle Glaucoma, Ocular Hypertension

Brief summary

AEs, visual field, visual acuity, macroscopic conjunctival hyperemia, slit-lamp biomicroscopic assessments, dilated ophthalmoscopic assessments (including optic disc assessment), contact ultrasound pachymetry, gonioscopy (implant assessment), and specular microscopy., Key endpoint: time from last Bimatoprost SR treatment in the lead-in study to first rescue treatment or first Bimatoprost SR PRN retreatment, Additional endpoints: time from SLT treatment in the lead-in study to first rescue treatment in the SLT-treated eye (Phase 3 study comparator) for patients from Study 192024-093 or -095

Interventions

Sponsors

AbbVie Deutschland GmbH & Co. KG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
AEs, visual field, visual acuity, macroscopic conjunctival hyperemia, slit-lamp biomicroscopic assessments, dilated ophthalmoscopic assessments (including optic disc assessment), contact ultrasound pachymetry, gonioscopy (implant assessment), and specular microscopy., Key endpoint: time from last Bimatoprost SR treatment in the lead-in study to first rescue treatment or first Bimatoprost SR PRN retreatment, Additional endpoints: time from SLT treatment in the lead-in study to first rescue treatment in the SLT-treated eye (Phase 3 study comparator) for patients from Study 192024-093 or -095

Countries

France, Germany, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026