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

Fase 1 Study to Evaluate the Safety and Tolerability of PRO-155 Ophthalmic Solution 0.09% in Healthy Volunteers.

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

Study Overview

• Status: Completed
• Conditions: Inflammation; Cataract
• Intervention / Treatment: Drug: Bromfenac

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 1

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44690
      • Unidad Medica "Grupo Pediátrico"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bromfenac; Drug: Bromfenac ophthalmic solution 1 drop 4 times per day	Drug: Bromfenac; Drug: Bromfenac Other names: PRO-155; Other Names: PROJECT SOPHIA PRO-155

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	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	10 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Laboratorios Sophia S.A de C.V.
• Investigators: Study Director: Leopoldo M Baiza-Durán, MD, Clinical Research Department. Laboratorios Sophia SA de CV; Principal Investigator: Alfredo Lizarraga-Corona, MD, Unidad Medica "Grupo Pediátrico"

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: February 14, 2012
• First Submitted That Met QC Criteria: February 16, 2012
• First Posted (Estimate): February 17, 2012

Study Record Updates

• Last Update Posted (Actual): October 16, 2019
• Last Update Submitted That Met QC Criteria: October 2, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Safety and tolerability; Ocular Inflammation; PRO-155; Ocular NSAIDs; Ocular Paint
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Lens Diseases; Inflammation; Cataract; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Bromfenac
• Other Study ID Numbers: BRON0611V1FI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No