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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by Laboratorios Sophia S.A de C.V..
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Laboratorios Sophia S.A de C.V. Identifier:
First received: February 14, 2012
Last updated: February 24, 2012
Last verified: February 2012
Study to evaluate the safety and tolerability of PRO-155 Ophthalmic Solution 0.09 % in healthy volunteers.

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

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 ]
    • 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 ]
    - 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.

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

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
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Please refer to this study by its identifier: NCT01535443

Unidad Medica "Grupo Pediátrico"
Guadalajara, Jalisco, Mexico, 44690
Sponsors and Collaborators
Laboratorios Sophia S.A de C.V.
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. Identifier: NCT01535443     History of Changes
Other Study ID Numbers: BRON0611V1FI
Study First Received: February 14, 2012
Last Updated: February 24, 2012

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

Additional relevant MeSH terms:
Pathologic Processes
Lens Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions processed this record on May 25, 2017