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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01535443
Recruitment Status : Unknown
Verified February 2012 by Laboratorios Sophia S.A de C.V..
Recruitment status was:  Active, not recruiting
First Posted : February 17, 2012
Last Update Posted : February 27, 2012
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Ocular Inflammation Cataract Drug: PRO-155 Ophthalmic Solution 0.09 % Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF PRO-155 OPHTHALMIC SOLUTION 0.09% IN HEALTHY VOLUNTEERS.
Study Start Date : September 2011
Primary Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: PRO-155 Ophthalmic Solution 0.09 % Drug: PRO-155 Ophthalmic Solution 0.09 %
PRO-155 Ophthalmic Solution 0.09 % applied twice to day during 10 days..


Outcome Measures

Primary Outcome Measures :
  1. Safety of PRO-155 Ophthalmic Solution [ Time Frame: 10 days ]
    • Evaluating of ocular signs and symptoms,visual acuity (VA), biomicroscopy, intraocular pressure (IOP), funduscopy and cup disc-ratio.
    • Evualuating the corneal and interpalpebral conjunctival staining (Fluoroscein and lissamine green staining).
    • Frequency, severity and relationship to study medication of all adverse events occurring during the course of the study.


Secondary Outcome Measures :
  1. Tolerability of PRO-155 Ophthalmic Solution. [ Time Frame: 10 days ]
    - Evaluating of ocular symptoms (redness eye, burning, foreign body sensation,photophobia and tearing) and ocular signs (hyperemia conjunctiva).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 systemics 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01535443


Locations
Mexico
Unidad Medica "Grupo Pediátrico"
Guadalajara, Jalisco, Mexico, 44690
Sponsors and Collaborators
Laboratorios Sophia S.A de C.V.
Investigators
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
More Information

Responsible Party: Laboratorios Sophia S.A de C.V.
ClinicalTrials.gov Identifier: NCT01535443     History of Changes
Other Study ID Numbers: BRON0611V1FI
First Posted: February 17, 2012    Key Record Dates
Last Update Posted: February 27, 2012
Last Verified: February 2012

Keywords provided by Laboratorios Sophia S.A de C.V.:
PRO-155
Ocular NSAIDs
Safety and tolerability
Ocular Inflammation
Ocular Paint

Additional relevant MeSH terms:
Inflammation
Cataract
Pathologic Processes
Lens Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions