At a glance
ClinicalIndex Comparison RecordN/ACompleted· 87 enrolled
Drug / intervention
CBL-101 Eye Drops +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study to Evaluate the Performance and Safety of CBL-101 Versus Vismed® Multi Eye Drops in the Management of Dry Eye
In Brief
A clinical study evaluating CBL-101 Eye Drops and Vismed® Multi Eye Drops for Dry Eye. Completed, enrolled 87 participants across 2 sites in 2 countries.
Detailed Summary
The primary objectives of this investigation are to show that the performance of CBL-101 Eye Drops is non-inferior to that of Vismed® Multi eye drops in subjects with moderate to severe keratoconjunctivitis sicca after 28 days, and to assess the safety of CBL-101 Eye Drops during a 90-day period with treatment administered 3 to 6 times per day.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye
CountriesBelgium, France
CollaboratorsBausch & Lomb Incorporated
Timeline
N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedNov 2016
Enrollment StartMar 2017
Primary CompletionSep 2019
TodayJul 2026
First PostedNov 29, 2016
Enrollment StartMar 1, 2017
Primary CompletionSep 17, 2019
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 9.6 years ago
Interventions
CBL-101 Eye Dropsdevice
CBL-101 Eye Drops 3 to 6 times per day for 3 months.
Vismed® Multi Eye Dropsdevice
Vismed® Multi 3 to 6 times per day for 3 months.