Overview

This trial is active, not recruiting.

Conditions ocular inflammation, cataract
Treatment pro-155 ophthalmic solution 0.09 %
Phase phase 1
Sponsor Laboratorios Sophia S.A de C.V.
Start date September 2011
End date February 2012
Trial size 35 participants
Trial identifier NCT01535443, BRON0611V1FI

Summary

Study to evaluate the safety and tolerability of PRO-155 Ophthalmic Solution 0.09 % in healthy volunteers.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
pro-155 ophthalmic solution 0.09 %
PRO-155 Ophthalmic Solution 0.09 % applied twice to day during 10 days..

Primary Outcomes

Measure
Safety of PRO-155 Ophthalmic Solution
time frame: 10 days

Secondary Outcomes

Measure
Tolerability of PRO-155 Ophthalmic Solution.
time frame: 10 days

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF PRO-155 OPHTHALMIC SOLUTION 0.09% IN HEALTHY VOLUNTEERS.
Principal investigator Alfredo Lizarraga-Corona, MD
Description A phase I, open label and unicentric clinical trial to evaluate the safety and tolerability of PRO-155 Ophthalmic Solution 0.09 % in healthy volunteers.
Trial information was received from ClinicalTrials.gov and was last updated in February 2012.
Information provided to ClinicalTrials.gov by Laboratorios Sophia S.A de C.V..