SYF7f0bb36dc72742e59a1e09009bca22feRegistry ID: 2023-504759-28-00|UnknownPhase 3
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Secondary identifiers
interventional
N/A
1 country
6
To evaluate the efficacy, tolerability, and safety of Bimatoprost 0.1 mg/ml unit dose formulation compared to the reference Lumigan® in patients with Chronic Open Angle Glaucoma or Ocular Hypertension.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 16, 2023
Actual (reported)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).
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.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
BIMATOPROST 0.1 MG/ML,
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
EYE DROPS, SOLUTION IN SINGLE-DOSE CONTAINER
View registry recordFormulated product
LUMIGAN 0.1 mg/ml eye drops, solution
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
EYE DROPS, SOLUTION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
BIMATOPROST 0.1 MG/ML,
Named ingredient: Bimatoprost
View registry recordLUMIGAN 0.1 mg/ml eye drops, solution
Named ingredient: Bimatoprost
View registry recordAzienda Ospedaliero-Universitaria Sant Andre
Rome, 00189, Italy
Azienda Sanitaria Locale 2 Lanciano Vasto Chieti
Chieti, 66100, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56124, Italy
Rocco Carmelo Pavese
First Submitted
October 16, 2023
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Source retrieved:
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Azienda Sociosanitaria Territoriale Santi Paolo E Carlo
Milan, 20142, Italy
Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia
Rome, 00184, Italy
IRCCS Ospedale Policlinico San Martino
Genoa, 16132, Italy