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.
1 other identifier
interventional
35
1 country
1
Brief Summary
Study to evaluate the safety and tolerability of PRO-155 Ophthalmic Solution 0.09 % in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2011
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 14, 2012
CompletedFirst Posted
Study publicly available on registry
February 17, 2012
CompletedResults Posted
Study results publicly available
July 19, 2019
CompletedOctober 16, 2019
October 1, 2019
1 month
February 14, 2012
June 3, 2013
October 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
Adverse Events
10 days
Findings in Posterior Segment
10 days
Intraocular Pressure (IOP)
10 days
Hyperemia
10 days
Burning
10 days
- +6 more secondary outcomes
Study Arms (1)
Bromfenac
EXPERIMENTALDrug: Bromfenac ophthalmic solution 1 drop 4 times per day
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male and female.
- Age ≥ 18 years old at screening visit
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unidad Medica "Grupo Pediátrico"
Guadalajara, Jalisco, 44690, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Baiza-Duran Leopoldo, Medial Director
- Organization
- Laboratorios Sophia, SA de CV
Study Officials
- PRINCIPAL INVESTIGATOR
Alfredo Lizarraga-Corona, MD
Unidad Medica "Grupo Pediátrico"
- STUDY DIRECTOR
Leopoldo M Baiza-Duran, MD
Clinical Research Department. Laboratorios Sophia SA de CV
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2012
First Posted
February 17, 2012
Study Start
September 1, 2011
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
October 16, 2019
Results First Posted
July 19, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share