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

Laboratorios Sophia

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PRO-156

Study type: Interventional

Funder types: Industry

Identifiers

NCT01871077

SOPH156-0612/I

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

PRO-156

Experimental group

Description:

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

Treatment:

Drug: PRO-156