At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 22 enrolled
Drug / intervention
Bepotastine Besilatedrug
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.
Phase I Clinical Study for the Evaluation of Safety and Tolerability of PRO-172 Ophthalmic Solution, Manufactured by Laboratorios Sophia, S.A. de C.V., When Applied on the Ocular Surface of Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating Bepotastine Besilate for Safety and 3 related conditions. Completed, enrolled 22 participants across 1 site.
Detailed Summary
Clinical phase I, controlled, non comparative, open, single center study evaluating the safety and tolerability of ophthalmic solution PRO-172 when applied on the ocular surface of healthy volunteers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSafety, Tolerability, Ocular Surface, Ocular Comfort
CountriesMexico
Collaborators--
Timeline
Phase 1CompletedFinished
202120222023202420252026
Enrollment StartSep 2020
Primary CompletionNov 2020
Study CompletionDec 2020
First PostedJan 2021
TodayJul 2026
First PostedJan 5, 2021
Enrollment StartSep 24, 2020
Primary CompletionNov 27, 2020
Study CompletionDec 8, 2020
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 5.5 years ago
Interventions
Bepotastine Besilatedrug
Bepotastine Besilate 1.5% QID (quater in die) for 7 days