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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Laboratorios Sophia S.A de C.V.
ClinicalTrials.gov Identifier:
NCT01535443
First received: February 14, 2012
Last updated: February 24, 2012
Last verified: February 2012
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF PRO-155 OPHTHALMIC SOLUTION 0.09% IN HEALTHY VOLUNTEERS.

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Laboratorios Sophia S.A de C.V.:

Primary Outcome Measures:
  • Safety of PRO-155 Ophthalmic Solution [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
    • 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:
  • Tolerability of PRO-155 Ophthalmic Solution. [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    - Evaluating of ocular symptoms (redness eye, burning, foreign body sensation,photophobia and tearing) and ocular signs (hyperemia conjunctiva).


Enrollment: 35
Study Start Date: September 2011
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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..

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Laboratorios Sophia S.A de C.V.
ClinicalTrials.gov Identifier: NCT01535443     History of Changes
Other Study ID Numbers: BRON0611V1FI
Study First Received: February 14, 2012
Last Updated: February 24, 2012
Health Authority: Mexico: Federal Commission for Protection Against Health Risks; Mexico: Ministry of Health

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

ClinicalTrials.gov processed this record on May 19, 2013