Safety and Tolerability of PRO-143 Ophthalmic Solution in Healthy Volunteers.

• Status: Withdrawn
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Study to evaluate the safety and tolerability of PRO-143 solution ophthalmic in healthy volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Laboratorios Sophia S.A de C.V.
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Healthy male and female.

• Age ≥ 18 years old at screening visit.

Exclusion Criteria:

• Any ocular or systemic condition.

• Patient with one blind eye.

• Visual acuity of 20/40 in any eye.

• Use of ocular or systemics medications.

• Contraindications or sensitivity to any component of the study treatments.

• Contact lens users.

• Ocular surgery within the past 3 months..

• Women who were not using an effective means of contraception or who were pregnant or nursing.

• Participation in any studies of investigational drugs within 90 days previous to the inclusion.