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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Laboratorios Sophia S.A de C.V..
Recruitment status was  Active, not recruiting
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
  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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pathologic Processes
Ophthalmic Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014