Safety and Tolerability of PRO-155 Ophthalmic Solution 0.09% in Healthy Volunteers.

NCT ID: NCT01535443

Last Updated: 2019-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2011-10-31

Brief Summary

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

Detailed 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.

Conditions

Inflammation; Cataract

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bromfenac

Drug: Bromfenac ophthalmic solution 1 drop 4 times per day

Group Type: EXPERIMENTAL

Bromfenac

Intervention Type: DRUG

Drug: Bromfenac Other names: PRO-155

Interventions

Bromfenac

Drug: Bromfenac Other names: PRO-155

Intervention Type: DRUG

Other Intervention Names

PROJECT SOPHIA PRO-155

Eligibility 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 systemic 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Laboratorios Sophia S.A de C.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alfredo Lizarraga-Corona, MD

Role: PRINCIPAL_INVESTIGATOR

Unidad Medica "Grupo Pediátrico"

Leopoldo M Baiza-Duran, MD

Role: STUDY_DIRECTOR

Clinical Research Department. Laboratorios Sophia SA de CV

Locations

Unidad Medica "Grupo Pediátrico"

Guadalajara, Jalisco, Mexico

Countries

Mexico

Other Identifiers

BRON0611V1FI

Identifier Type: -

Identifier Source: org_study_id