Phase 1
N=35
Safety and Tolerability of PRO-155 Ophthalmic Solution 0.09% in Healthy Volunteers.
Inflammation · Cataract
Bottom Line
View on ClinicalTrials.gov: NCT01535443 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Visual Acuity — 20.3; 20.2 units on a scale — p=.374
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Bromfenac (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Laboratorios Sophia S.A de C.V.
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity |
20.3; 20.2 | .374 |
| SECONDARY Adverse Events |
1 | — |
| SECONDARY Findings in Posterior Segment |
1; 1 | — |
| SECONDARY Intraocular Pressure (IOP) |
13.3; 13.4 | — |
| SECONDARY Hyperemia |
0; 0 | — |
| SECONDARY Burning |
34; 0; 0; 0; 33; 0 | — |
| SECONDARY Tearing |
34; 0; 0; 0; 34; 0 | — |
| SECONDARY Foreign Body Sensation |
34; 0; 0; 0; 34; 0 | — |
| SECONDARY Photophobia |
34; 0; 0; 0; 34; 0 | — |
| SECONDARY Chemosis |
34; 0; 0; 0; 34; 0 | — |
| SECONDARY Corneal Damage by Fluorescein Staining Test |
34; 0; 0; 0; 34; 0 | — |
| SECONDARY Corneal Damage by Lissamine Green Staining Test |
34; 0; 0; 0; 34; 0 | — |
Summary
Study to evaluate the safety and tolerability of PRO-155 Ophthalmic Solution 0.09 % in healthy volunteers.
Eligibility 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 systemic 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.
Data sourced from ClinicalTrials.gov (NCT01535443). 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.