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RANDOMIZED, OPEN LABEL, PARALLEL-GROUP, TWO-ARM, MULTICENTER STUDY WITH CLINICAL ENDPOINT COMPARING PRESERVATIVE FREE BIMATOPROST OPHTHALMIC SOLUTION 0.1 MG/ML AND LUMIGAN® (BIMATOPROST OPHTHALMIC SOLUTION) 0.1 MG/ML IN PATIENTS WITH CHRONIC OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION IN ONE OR BOTH EYES.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504759-28-00
Acronym
BIM-001
Enrollment
124
Registered
2024-02-14
Start date
2024-04-05
Completion date
Unknown
Last updated
2024-05-10

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

Conditions

Chronic Open-angle Glaucoma, Ocular Hypertension

Brief summary

Difference in intraocular pressure (IOP) of one eye, (if both eyes have been treated only the contralateral right eye will be chosen) between the two treatment groups of the mean percentage reduction from baseline (V2) to day 42 (V5).

Detailed description

Efficacy: Reduction in IOP, at each follow-up time point, as compared with baseline, in the two study groups., Tolerability: Local tolerability assessed through Ocular Surface Disease Index (OSDI), Efron scale, Oxford scale, from baseline (V2) to day 42 (V5)., Safety: Quantitative and Qualitative Evaluation of Safety in terms of adverse events reported.

Interventions

DRUGBIMATOPROST 0.1 MG/ML
DRUGLUMIGAN 0.1 mg/ml eye drops

Sponsors

Genetic S.p.A.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Difference in intraocular pressure (IOP) of one eye, (if both eyes have been treated only the contralateral right eye will be chosen) between the two treatment groups of the mean percentage reduction from baseline (V2) to day 42 (V5).

Secondary

MeasureTime frame
Efficacy: Reduction in IOP, at each follow-up time point, as compared with baseline, in the two study groups., Tolerability: Local tolerability assessed through Ocular Surface Disease Index (OSDI), Efron scale, Oxford scale, from baseline (V2) to day 42 (V5)., Safety: Quantitative and Qualitative Evaluation of Safety in terms of adverse events reported.

Countries

Italy

Outcome results

None listed

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