Phase 1
N=24
Safety and Tolerability of the Ophthalmic Gel PRO-167 Versus Corneregel® on Healthy Subjects.
Dry Eye · Dry Eye Syndrome of Unspecified Lacrimal Gland
Bottom Line
View on ClinicalTrials.gov: NCT03520348 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Goblet Cell Density (GCD) — 444; 440 cells/mm^2 — p=0.285
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PRO-167 (Drug); Corneregel (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 Goblet Cell Density (GCD) |
444; 440 | 0.285 |
| SECONDARY Presence of Adverse Events (EAS) |
7; 6 | 0.680 |
| SECONDARY Intraocular Pressure (IOP) |
13.14; 13.56 | 0.839 |
| SECONDARY Breakup Time (BUT) |
8.92; 7.75 | 0.137 |
| SECONDARY Chemosis |
0; 0 | — |
| SECONDARY Ocular Burning (OB) |
66.7; 75; 29.2; 16; 4.2; 8.3 | 0.667 |
| SECONDARY Epithelial Defects (ED) |
8; 8; 4; 3; 0; 1 | 0.561 |
| SECONDARY Conjunctival Hyperemia (CH) |
16.7; 8.3; 66.6; 66.7; 16.7; 25 | 1.000 |
| SECONDARY Foreign Body Sensation (FBS) |
79.2; 91.7; 20.8; 8.3; 0; 0 | 0.317 |
| SECONDARY Ocular Pruritus (P) |
41.7; 66.7; 50; 16.7; 8.3; 16.7 | 0.414 |
Summary
Title of the study:
Phase I clinical trial, to evaluate the safety and tolerability of the ophthalmic gel PRO-167 versus Corneregel®, on the ocular surface of ophthalmological and clinically healthy subjects.
Methodology:
Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
Goals:
To evaluate the safety and tolerability of the ophthalmic gel PRO-167 manufactured by Laboratorios Sophia S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis:
Ophthalmic gel PRO-167 has a safety and tolerability profile similar to that of its 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.
- Visual capacity 20/30 or better, in both eyes.
- Intraocular pressure ≥11 and ≤ 21 mmHg.
Exclusion 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.
- Women who are pregnant or breastfeeding.
- Women without a history of hysterectomy, oophorectomy, who do not ensure a hormonal contraceptive method or intrauterine device during the study period.
- Subjects with participation in clinical research studies 90 days prior to inclusion in the present study.
- Diagnosis of liver disease or triple 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 quantity and frequency)
- Positive alcoholism (specified as the consumption of alcoholic beverages, regardless of quantity and frequency, during the study intervention period)
- Contact lens users
Data sourced from ClinicalTrials.gov (NCT03520348). 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.