Phase I Clinical Study, to Evaluate the Safety and Tolerability of the Ophthalmic Gel PRO-167 Versus Corneregel®, on the Ocular Surface of Ophthalmological and Clinically Healthy Subjects.
Overview
- Phase
- Phase 1
- Intervention
- PRO-167
- Conditions
- Dry Eye
- Sponsor
- Laboratorios Sophia S.A de C.V.
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Goblet Cell Density (GCD)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Detailed Description
Therapeutic indication: Corneal surface reepithelizing Statistical methodology: The data will be expressed with measures of central tendency: mean and standard deviation for the quantitative variables. The qualitative variables will be presented in frequencies and percentages. The statistical analysis will be carried out through the Mann-Whitney U test for quantitative variables. The difference between the qualitative variables will be analyzed by means of square chi (Chi2). An alpha ≤ 0.05 will be considered significant. Study period: 3 to 4 months Development phase: I Number of patients: 24 subjects, divided into 2 groups (12 eyes exposed per group) Test product, dose and route of administration, lot number: PRO-167. Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico. * Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom of the right eye sac. * Route of administration: ophthalmic. Reference product, dose and route of administration, lot: * Corneregel. Dexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin, Germany. * Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom of the right eye sac. * Route of administration: ophthalmic Evaluation criteria: Primary security outcome variable: - Density of goblet cells. Secondary security variables: * Epithelial defects in cornea and conjunctiva. * Presence of adverse events. Secondary outcome variables: * Intraocular pressure. * Visual ability * Break time of the tear film. Outcome variables of tolerability: * Burning. * Foreign body sensation. * Itching. * Eye comfort index.
Investigators
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)
Arms & Interventions
PRO-167
Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom
Intervention: PRO-167
Corneregel®
Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom of the right eye sac.
Intervention: Corneregel
Outcomes
Primary Outcomes
Goblet Cell Density (GCD)
Time Frame: will be evaluated at the end of the treatment at the final visit (day 11)
the cells will be measured per square millimeter, it is a continuous variable taken by means of cytology per impression, the normal value is higher than 500 cells per square millimeter
Secondary Outcomes
- Chemosis(will be evaluated at the end of the treatment at the final visit (day 11))
- Presence of Adverse Events (EAS)(during the 11 days of evaluation, including the safety call (day 13).)
- Intraocular Pressure (IOP)(will be evaluated at the end of the treatment at the final visit (day 11))
- Epithelial Defects (ED)(will be evaluated at the end of the treatment at the final visit (day 11))
- Breakup Time (BUT)(will be evaluated at the end of the treatment at the final visit (day 11))
- Conjunctival Hyperemia (CH)(will be evaluated at the end of the treatment at the final visit (day 11))
- Ocular Burning (OB)(will be evaluated at the end of the treatment at the final visit (day 11))
- Foreign Body Sensation (FBS)(will be evaluated at the end of the treatment at the final visit (day 11))
- Ocular Pruritus (P)(will be evaluated at the end of the treatment at the final visit (day 11))