Overview

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Withdrawn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.