Phase 1
N=30
Safety and Tolerability of the PRO-174 Versus Sophixín Ofteno®, on the Ocular Surface of Healthy Subjects
Conjunctivitis · Conjunctivitis, Bacterial
Bottom Line
View on ClinicalTrials.gov: NCT03519516 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Number of Adverse Events (EAS) — 11; 10 adverse events — p=0.749
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PRO-174 (Drug); Sophixín Ofteno® (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Laboratorios Sophia S.A de C.V.
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adverse Events (EAS) |
11; 10 | 0.749 |
| PRIMARY Ocular Burning (OB) |
86.7; 57.1; 6.7; 14.3; 6.7; 28.6 | 0.041 sig |
| SECONDARY Intraocular Pressure (IOP) |
12.53; 12.68 | 0.694 |
| SECONDARY Breakup Time (BUT) |
15.27; 15.79 | 0.495 |
| SECONDARY Number of Eyes With Epithelial Defects (ED) by Grade |
2; 0; 28; 28; 3; 0 | 0.492 |
| SECONDARY Percentage of Eyes With Conjunctival Hyperemia (CH) by Grade |
96.7; 92.9; 3.3; 0; 0; 0 | 0.213 |
| SECONDARY Number of Eyes With Foreign Body Sensation (FBS) by Grade |
30; 28; 0; 0; 0; 0 | — |
| SECONDARY Number of Eyes With Ocular Pruritus (P) by Grade |
24; 24; 4; 2; 2; 2 | 0.741 |
| SECONDARY Number of Eyes of Chemosis |
0; 0 | — |
| SECONDARY Visual Capacity |
20.6; 20 | 0.110 |
Summary
Phase I clinical trial, to evaluate the safety and tolerability of the ophthalmic solution PRO-174 versus Sophixín Ofteno®, elaborated by Laboratorios Sophia, S.A. of C.V. on the ocular surface of ophthalmologically and clinically healthy subjects.
Goals:
To evaluate the safety and tolerability of the formulation PRO-174 manufactured by Laboratorios Sophia, S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis:
The ophthalmic solution PRO-174 presents a safety and tolerability profile similar to the comparator in healthy subjects.
Eligibility Criteria
Inclusion Criteria
- Signed informed consent.
- Systemically and ophthalmologically healthy subjects evaluated during the clinical history.
- Age between 18 to 45 years.
- Both genders.
- Blood tests (complete blood count, blood chemistry of three elements and liver function tests) within normal parameters specified by the reference laboratory with a lower and upper margin of 10%.
- Vital signs within normal parameters. (Vital signs at rest: blood pressure ≤ 139/89 mmHg, heart rate 60 -100 beats per minute and respiratory rate of 12-24 breaths per minute).
- Visual capacity 20/30 or better, in both eyes.
- Intraocular pressure ≥11 and ≤ 21 mmHg.
Exclusion Criteria
General criteria
- Subjects with a history of hypersensitivity to any of the components of the research products.
- Subject users of topical ophthalmic medications of any pharmacological group.
- Subject users of medication by any other route of administration.
- Pregnant or lactating women.
- Women of childbearing age, who do not ensure a hormonal contraceptive method or intrauterine device during the study period or without a history of bilateral tubal obstruction, oophorectomy or hysterectomy; as fertile age we understand women who have not had their menopause, defined as 12 months since the last menstruation in women over 40 years.
- Subjects with participation in clinical research studies 90 days prior to inclusion in the present study.
- Diagnosis of liver disease or elevation to three times the normal upper value of any of the following liver enzymes: aspartate transferase (AST), alanine transferase (ALT) or bilirubin.
- Inability to attend or answer the evaluations made in each of the visits.
- Positive smoking (specified as cigarette consumption regardless of amount and frequency)
- Positive alcoholism (specified as the consumption of alcoholic beverages, regardless of quantity and frequency, during the study intervention period).
- Contact lens users.
- An occlusive iridocorneal angle, defined as a trabecular mesh visible at less than 90 ° from the angular circumference to gonioscopy.
Data sourced from ClinicalTrials.gov (NCT03519516). 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.