Safety and Tolerability of PRO-155 Ophthalmic Solution 0.09% in Healthy Volunteers. (PRO-155)
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|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
|Condition or disease||Intervention/treatment||Phase|
|Ocular Inflammation Cataract||Drug: PRO-155 Ophthalmic Solution 0.09 %||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF PRO-155 OPHTHALMIC SOLUTION 0.09% IN HEALTHY VOLUNTEERS.|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||February 2012|
|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..
- 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.
- 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).
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
|Unidad Medica "Grupo Pediátrico"|
|Guadalajara, Jalisco, Mexico, 44690|
|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|