Phase 1
N=30
Safety and Tolerability of the Ophthalmic Solution PRO-156 in Ophthalmologically Healthy Volunteers.
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01871077 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Visual Acuity (VA) — 19.9; 19.83 score on a scale — p=0.890
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PRO-156 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Laboratorios Sophia S.A de C.V.
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity (VA) |
19.9; 19.83 | 0.890 |
| SECONDARY Intraocular Pressure (IOP) |
12.60; 12.23 | 0.078 |
| SECONDARY Number of Eyes With Epithelial Defects |
— | 1.000 |
| SECONDARY Number of Cases With Adverse Events |
6 | .497 |
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
Eligibility Criteria
Inclusion Criteria
- Healthy male and female.
- Age between 18 and 40 years old at screening visit.
- Signed informed consent
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01871077). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.