Safety and Tolerability of the Ophthalmic Solution PRO-156 in Ophthalmologically Healthy Volunteers.

NCT ID: NCT01871077

Last Updated: 2019-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2013-12-31

Brief Summary

The purpose of this study is to evaluate safety and tolerability of the ophthalmic solution PRO-156 over the ocular surface of ophthalmologically healthy volunteers

Detailed Description

A phase I, open label and unicentric clinical trial to evaluate the safety and tolerability of the ophthalmic solution PRO-143 over the ocular surface of ophthalmologically healthy volunteers.

Conditions

Healthy

Study Design

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

Study Groups

PRO-156

Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days.

Group Type: EXPERIMENTAL

PRO-156

Intervention Type: DRUG

Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days.

Interventions

PRO-156

Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days.

Intervention Type: DRUG

Other Intervention Names

Ketorolac

Eligibility Criteria

Inclusion Criteria

• Healthy male and female.
• Age between 18 and 40 years old at screening visit.
• Signed informed consent

Exclusion Criteria

• Patient with one blind eye.
• Any ocular or systemic condition.
• Visual acuity of 20/100 in any eye.
• Use of ocular or systemic medication.
• Contraindications or sensitivity to any component of the study treatment.
• Contact lens users.
• Ocular surgery within the past 3 months..
• Pregnant, nursing or childbearing potential women who were not using effective contraception.
• Participation in any studies of investigational drugs within 90 days previous to the inclusion.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 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

Mauricio Casillas, MD

Role: PRINCIPAL_INVESTIGATOR

Independent Clinical Research Center

Other Identifiers

SOPH156-0612/I

Identifier Type: -

Identifier Source: org_study_id