Dry Eye Clinical Trial
— PRO-167/IOfficial title:
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.
Verified date | May 2019 |
Source | Laboratorios Sophia S.A de C.V. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | July 16, 2018 |
Est. primary completion date | May 22, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Mexico | Centro Oftalmológico San Angel | Guadalajara | Jalisco |
Lead Sponsor | Collaborator |
---|---|
Laboratorios Sophia S.A de C.V. |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Goblet Cell Density (GCD) | 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 | will be evaluated at the end of the treatment at the final visit (day 11) | |
Secondary | Presence of Adverse Events (EAS) | the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent. | during the 11 days of evaluation, including the safety call (day 13). | |
Secondary | Intraocular Pressure (IOP) | the intraocular pressure will be evaluated by means of the Goldman applanation tonometry whose unit of measurement is millimeters of mercury (mmHg), it is a continuous variable and its normality range is between 11 - 21 mmHg | will be evaluated at the end of the treatment at the final visit (day 11) | |
Secondary | Breakup Time (BUT) | breakup time lacrimal film is a continuous variable that will be measured in seconds, evaluating the time it takes to break it, is done by direct counting and the normality range greater than 10 seconds. | will be evaluated at the end of the treatment at the final visit (day 11) | |
Secondary | Chemosis | The chemosis will be evaluated, as a nominal variable, by direct observation and it will be staged as present and absent, where the normality is that said variable is absent. | will be evaluated at the end of the treatment at the final visit (day 11) | |
Secondary | Ocular Burning (OB) | ocular burning is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale: Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent.Frequency: At all times, almost at all times, 50% of the time, almost in no time, at any time. where the normality of the frequency is in no time. | will be evaluated at the end of the treatment at the final visit (day 11) | |
Secondary | Epithelial Defects (ED) | The epithelial defects will be evaluated by means of two stains, green lissamine, it is a discrete variable that will be realized by direct observation, it will be staged according to the degrees of the oxford scale that go from 0 to 5 (0-V) according to its severity, where 0 is the normal lower limit and 5 the upper limit of defects. | will be evaluated at the end of the treatment at the final visit (day 11) | |
Secondary | Conjunctival Hyperemia (CH) | Conjunctival hyperemia will be evaluated as an ordinal variable, by direct observation and staged using the Efron scale as Normal / Very Light / Mild / Moderate / Severe. Based on this scale, the normal and mild stages are considered without pathologies or normal. Mild, moderate and severe are considered pathological. | will be evaluated at the end of the treatment at the final visit (day 11) | |
Secondary | Foreign Body Sensation (FBS) | Foreign body sensation is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale: Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent. Frequency: At all times, almost at all times, 50% of the time, almost in no time, at any time. where the normality of the frequency is in no time. |
will be evaluated at the end of the treatment at the final visit (day 11) | |
Secondary | Ocular Pruritus (P) | Ocular pruritus is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale: Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent. Frequency: At all times, almost at all times, 50% of the time, almost in no time, at any time. where the normality of the frequency is in no time. |
will be evaluated at the end of the treatment at the final visit (day 11) |
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