At a glance
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Phase I Clinical Trial, to Evaluate the Safety and Tolerability of the Ophthalmic Solution PRO-174 Versus Sophixín Ofteno®, Elaborated by Laboratorios Sophia on the Ocular Surface of Ophthalmological and Clinically Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating PRO-174 and Sophixín Ofteno® for Conjunctivitis and Conjunctivitis, Bacterial. Completed, enrolled 30 participants across 1 site.
Detailed Summary
Phase I clinical trial, to evaluate the safety and tolerability of the ophthalmic solution PRO-174 versus Sophixín Ofteno®, elaborated by Laboratorios Sophia, S.A. of C.V. on the ocular surface of ophthalmologically and clinically healthy subjects. Goals: To evaluate the safety and tolerability of the formulation PRO-174 manufactured by Laboratorios Sophia, S.A. of C.V. on the ocular surface of clinically healthy subjects. Hypothesis: The ophthalmic solution PRO-174 presents a safety and tolerability profile similar to the comparator in healthy subjects.
Study Details
Timeline
Interventions
Pharmaceutical form: ophthalmic solution * Prepared by: Laboratorios Sophia, S.A. of C.V. * Description of the solution: transparent solution, free of visible particles. * Description of container: sterile multi-dose bottle
* Active substance: Ciprofloxacin 0.3% * Pharmaceutical form: Ophthalmic solution * Prepared by: Laboratorios Sophia, S.A. of C.V. * Description of the solution: transparent solution, free of visible particles. * Description of container: sterile multi-dose bottle