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

Phase 1

Completed

• Conditions: Inflammation; Cataract
• Interventions: Drug: Bromfenac

• Registration Number: NCT01535443
• Lead Sponsor: Laboratorios Sophia S.A de C.V.

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.

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Study First Submitted: 2012-02-14
• Study First Submitted QC: 2012-02-16
• Study First Posted: 2012-02-17
• Results First Submitted: 2013-06-03
• Results First Submitted QC: 2019-05-09
• Results First Posted: 2019-07-19
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-02
• Last Update Posted: 2019-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bromfenac	Bromfenac	Drug: Bromfenac ophthalmic solution 1 drop 4 times per day

Primary Outcome Measures

Name	Time	Method
Visual Acuity	10 days	A Snellen chart is an eye chart that can be used to measure visual acuity. consisting of a scale ranging from 20 to 200, where 20 is the best visual capacity and 200 is the worst

Secondary Outcome Measures

Name	Time	Method
Burning	10 days	Eye ocular burning will be reported according to the following scale: absent, mild, moderate and severe.
Findings in Posterior Segment	10 days	Abnormal bores will be reported when assessing the integrity of the posterior segment, the unit of measure will be number of findings.
Intraocular Pressure (IOP)	10 days	Intraocular pressure (IOP) measurement by applanation tonometry. The unit of measurement will be millimeters of mercury (mmhg) the normal range will be considered 11 to 21 mmhg.
Hyperemia	10 days	The red eye will be evaluated by the absence or presence of hyperemia.
Chemosis	10 days	chemosis will be reported according to the following scale: absent, mild, moderate and severe.
Corneal Damage by Fluorescein Staining Test	10 days	Corneal damage will be reported by Fluorescein eye staining using the following scale: absent, mild, moderate, and severe.
Corneal Damage by Lissamine Green Staining Test	10 days	Corneal damage will be reported by lissamine green staining using the following scale: absent, mild, moderate, and severe.
Tearing	10 days	Tearing will be reported according to the following scale: absent, mild, moderate and severe.
Foreign Body Sensation	10 days	Foreign body sensation will be reported according to the following scale: absent, mild, moderate and severe.
Photophobia	10 days	photophobia will be reported according to the following scale: absent, mild, moderate and severe.
Adverse Events	10 days	will be reported the presence of adverse events presented in the study group during the intervention period .

Trial Locations

Locations (1)

Unidad Medica "Grupo Pediátrico"; 🇲🇽 Guadalajara, Jalisco, Mexico