Safety and Tolerability of the Ophthalmic Solution PRO-179 Compared With Travatan® (PRO-179/I)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03965052|
Recruitment Status : Completed
First Posted : May 28, 2019
Results First Posted : December 12, 2019
Last Update Posted : December 12, 2019
Phase I clinical study, to evaluate the safety and tolerability of the ophthalmic solution PRO-179 compared with Travatan®, on the ocular surface of clinically healthy subjects.
Goals: To evaluate the safety and tolerability of the formulation PRO-179 manufactured by Sophia Laboratories S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis:The ophthalmic solution PRO-179 presents a profile of safety and tolerability similar to Travatan® in healthy subjects.
Methodology: Clinical trial Phase I, controlled, of parallel groups, double blind, with randomization.
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma||Drug: PRO 179 Drug: Travatan 0.004 % Ophthalmic Solution||Phase 1|
Number of patients: n= 24, 12 subjects per group (both eyes). Main inclusion criteria: Clinically healthy subjects.
duration: 10 days.
Duration of subject in the study: 15 to 22 days.
Adverse events will be reported and cataloged based on the MedDRA dictionary and will be reported to the corresponding regulatory entity.
The sponsor will carry out monitoring or quality visits to the research sites where it corroborates the information of the source documents and will contrast them with the information presented in the electronic CRF. Electronic case report forms will be evaluated by the clinical research associate and the clinical team of the sponsor (medical ophthalmologist researcher and pharmacologist of clinical safety).
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 by means of the Mann-Whitney U test for the quantitative variables for the difference between the groups. The difference between the qualitative variables will be analyzed by means of X2 (Chi2) or Fisher's exact. An alpha ≤ 0.05 will be considered significant.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||double blind, with randomization.|
|Masking:||Double (Investigator, Outcomes Assessor)|
Blinding will correspond to the principal investigator and coinvestigator. In addition, the statistical analysis will be carried out in a blinded manner for the final analysis. Blinding can not be guaranteed in the subject.
The masking will be done through the secondary container. The primary packaging will not be masked by the morphological difference between them. The sponsor and the research center will have two teams blinded / not blinded.
They will be identified by means of identical labels. Which, in accordance with current and applicable regulations, must contain at least:
|Official Title:||Phase I Clinical Study, to Evaluate the Safety and Tolerability of the Ophthalmic Solution PRO-179 Compared With Travatan®, on the Ocular Surface of Clinically Healthy Subjects.|
|Actual Study Start Date :||April 24, 2019|
|Actual Primary Completion Date :||July 2, 2019|
|Actual Study Completion Date :||August 29, 2019|
Dosage: 1 drop every 24 hours, at night, in both eyes.
Drug: PRO 179
Active Comparator: Travatan®
Dosage: 1 drop every 24 hours, at night, in both eyes.
Drug: Travatan 0.004 % Ophthalmic Solution
Other Name: Travoprost 0.004% ophthalmic solution
- Number of Participants With Adverse Events [ Time Frame: during the 14 days of evaluation, including the safety call (day 14). ]primary security variable the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent. it will be evaluated by the number of reported cases per group.
- Eye Comfort Index [ Time Frame: will be evaluated at the end of the treatment, at the final visit (day 11) ]It is a questionnaire designed to measure the irritation of the ocular surface with Rasch analysis to produce estimates on a linear scale of intervals (ratings: 0-100).The Eye comfort index contains items that focus on the discomfort associated with alterations of the ocular surface.(0: None discomfort, 100: high discomfort).
- Number of Eyes With Epithelial Defects by Grade [ Time Frame: will be evaluated at the end of the treatment, at the final visit (day 11) ]The epithelial defects will be evaluated by means of two stains, lissamine green and fluorescein, 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.
- Visual Ability [ Time Frame: will be evaluated at the end of the treatment, at the final visit (day 11) ]
The visual capacity variable will be reported using as a unit of measure a fraction, this is taken from a visual test with the Snellen primer, it is a Nominal type variable. where the optimal vision is 20/20 and the worst vision is 20/200, higher values represent a worst vision. The result of the Snellen chart has equivalents in an international logarithmic system called Logmar (logarithm of the minimum angle of resolution) for better understanding.
Snellen Scale: 20/200, 20/100, 20/50, 20/40, 20/30, 20/25, 20/20, 20/15, 20/12, 20/10.
Snellen / LogMAR equivalences: 20/200= 1.0, 20/100=0.7, 20/50=0.4, 20/40=0.3, 20/30=0.2, 20/25=0.1, 20/20=0.0, 20/15=0.13, 20/12=0.2, 20/10=-0.3, etc.
- Percentage of Eyes With Conjunctival Hyperemia (CH) by Grade [ Time Frame: will be evaluated at the end of the treatment, at the final visit (day 11) ]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.
- Number of Eyes of Chemosis [ Time Frame: will be evaluated at the end of the treatment, at the final visit (day 11) ]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.
- Changes in Intraocular Pressure [ Time Frame: will be evaluated at the end of the treatment, at the final visit (day 11) ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965052
|Jose Navarro Partida|
|Guadalajara, Jalisco, Mexico, 45160|
|Study Director:||Leopoldo Baiza Durán, MD||Laboratorios Sophia S.A de C.V.|