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

Laboratorios Sophia

Status and phase: Completed; Phase 1

Conditions: Inflammation; Cataract

Treatments: Drug: Bromfenac

Study type: Interventional

Funder types: Industry

Identifiers

NCT01535443

BRON0611V1FI

Details and patient eligibility

About

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

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Bromfenac

Experimental group

Description:

Drug: Bromfenac ophthalmic solution 1 drop 4 times per day

Treatment:

Drug: Bromfenac