Status:
COMPLETED
Safety and Tolerability of the Ophthalmic Solution PRO-156 in Ophthalmologically Healthy Volunteers.
Lead Sponsor:
Laboratorios Sophia S.A de C.V.
Conditions:
Healthy
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate safety and tolerability of the ophthalmic solution PRO-156 over the ocular surface of ophthalmologically healthy volunteers
Detailed Description
A phase I, open label and unicentric clinical trial to evaluate the safety and tolerability of the ophthalmic solution PRO-143 over the ocular surface of ophthalmologically healthy volunteers.
Eligibility Criteria
Inclusion
- Healthy male and female.
- Age between 18 and 40 years old at screening visit.
- Signed informed consent
Exclusion
- Patient with one blind eye.
- Any ocular or systemic condition.
- Visual acuity of 20/100 in any eye.
- Use of ocular or systemic medication.
- Contraindications or sensitivity to any component of the study treatment.
- Contact lens users.
- Ocular surgery within the past 3 months..
- Pregnant, nursing or childbearing potential women who were not using effective contraception.
- Participation in any studies of investigational drugs within 90 days previous to the inclusion.
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01871077
Start Date
September 1 2013
End Date
December 1 2013
Last Update
October 25 2019
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