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

Primary Purpose

Inflammation, Cataract

Status
Completed
Phase
Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
Bromfenac
Sponsored by
Laboratorios Sophia S.A de C.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammation focused on measuring PRO-155, Ocular NSAIDs, Safety and tolerability, Ocular Inflammation, Ocular Paint

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Unidad Medica "Grupo Pediátrico"

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bromfenac

Arm Description

Drug: Bromfenac ophthalmic solution 1 drop 4 times per day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse Events
will be reported the presence of adverse events presented in the study group during the intervention period .
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.
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.
Hyperemia
The red eye will be evaluated by the absence or presence of hyperemia.
Burning
Eye ocular burning will be reported according to the following scale: absent, mild, moderate and severe.
Tearing
Tearing will be reported according to the following scale: absent, mild, moderate and severe.
Foreign Body Sensation
Foreign body sensation will be reported according to the following scale: absent, mild, moderate and severe.
Photophobia
photophobia will be reported according to the following scale: absent, mild, moderate and severe.
Chemosis
chemosis will be reported according to the following scale: absent, mild, moderate and severe.
Corneal Damage by Fluorescein Staining Test
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
Corneal damage will be reported by lissamine green staining using the following scale: absent, mild, moderate, and severe.

Full Information

First Posted
February 14, 2012
Last Updated
October 2, 2019
Sponsor
Laboratorios Sophia S.A de C.V.
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1. Study Identification

Unique Protocol Identification Number
NCT01535443
Brief Title
Safety and Tolerability of PRO-155 Ophthalmic Solution 0.09% in Healthy Volunteers.
Acronym
PRO-155
Official Title
Fase 1 Study to Evaluate the Safety and Tolerability of PRO-155 Ophthalmic Solution 0.09% in Healthy Volunteers.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Sophia S.A de C.V.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Cataract
Keywords
PRO-155, Ocular NSAIDs, Safety and tolerability, Ocular Inflammation, Ocular Paint

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bromfenac
Arm Type
Experimental
Arm Description
Drug: Bromfenac ophthalmic solution 1 drop 4 times per day
Intervention Type
Drug
Intervention Name(s)
Bromfenac
Other Intervention Name(s)
PROJECT SOPHIA PRO-155
Intervention Description
Drug: Bromfenac Other names: PRO-155
Primary Outcome Measure Information:
Title
Visual Acuity
Description
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
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Adverse Events
Description
will be reported the presence of adverse events presented in the study group during the intervention period .
Time Frame
10 days
Title
Findings in Posterior Segment
Description
Abnormal bores will be reported when assessing the integrity of the posterior segment, the unit of measure will be number of findings.
Time Frame
10 days
Title
Intraocular Pressure (IOP)
Description
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.
Time Frame
10 days
Title
Hyperemia
Description
The red eye will be evaluated by the absence or presence of hyperemia.
Time Frame
10 days
Title
Burning
Description
Eye ocular burning will be reported according to the following scale: absent, mild, moderate and severe.
Time Frame
10 days
Title
Tearing
Description
Tearing will be reported according to the following scale: absent, mild, moderate and severe.
Time Frame
10 days
Title
Foreign Body Sensation
Description
Foreign body sensation will be reported according to the following scale: absent, mild, moderate and severe.
Time Frame
10 days
Title
Photophobia
Description
photophobia will be reported according to the following scale: absent, mild, moderate and severe.
Time Frame
10 days
Title
Chemosis
Description
chemosis will be reported according to the following scale: absent, mild, moderate and severe.
Time Frame
10 days
Title
Corneal Damage by Fluorescein Staining Test
Description
Corneal damage will be reported by Fluorescein eye staining using the following scale: absent, mild, moderate, and severe.
Time Frame
10 days
Title
Corneal Damage by Lissamine Green Staining Test
Description
Corneal damage will be reported by lissamine green staining using the following scale: absent, mild, moderate, and severe.
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfredo Lizarraga-Corona, MD
Organizational Affiliation
Unidad Medica "Grupo Pediátrico"
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leopoldo M Baiza-Duran, MD
Organizational Affiliation
Clinical Research Department. Laboratorios Sophia SA de CV
Official's Role
Study Director
Facility Information:
Facility Name
Unidad Medica "Grupo Pediátrico"
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44690
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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