At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I Clinical Study, to Evaluate the Safety and Tolerability of the Ophthalmic Solution PRO-179 Compared With Travatan®, on the Ocular Surface of Clinically Healthy Subjects.
In Brief
A Phase 1 clinical trial evaluating PRO 179 and Travatan 0.004 % Ophthalmic Solution for Glaucoma. Completed, enrolled 24 participants across 1 site.
Detailed Summary
Phase I clinical study, to evaluate the safety and tolerability of the ophthalmic solution PRO-179 compared with Travatan®, on the ocular surface of clinically healthy subjects. Goals: To evaluate the safety and tolerability of the formulation PRO-179 manufactured by Sophia Laboratories S.A. of C.V. on the ocular surface of clinically healthy subjects. Hypothesis:The ophthalmic solution PRO-179 presents a profile of safety and tolerability similar to Travatan® in healthy subjects. Methodology: Clinical trial Phase I, controlled, of parallel groups, double blind, with randomization.
Study Details
Timeline
Interventions
* Generic name: Travoprost * Distinctive denomination: Bristrio® (PRO-179) * Active principles: Travoprost 0.004%. * Pharmaceutical form: Ophthalmic solution * Presentation: multi-dose dropper bottle, 2.5 milliliters. * Prepared by: Sophia Laboratories, S.A. of C.V. * Description of the solution: transparent solution, free of visible particles. * Description of container: White bottle with 5 milliliters capacity, made of low density polyethylene.
* Generic name: Travoprost * Distinctive denomination: Travatan® * Active ingredients: Travoprost 0.004% * Pharmaceutical form: Ophthalmic solution. * Presentation: multi-dose dropper bottle, 2.5 milliliters. * Prepared by: Alcon Laboratories Inc. * Description of the solution: transparent solution, free of visible particles. * Consult information to prescribe.