Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Laboratorios Sophia S.A de C.V.

Brief Summary:

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

Detailed Description:

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).

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 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double blind, with randomization.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:

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:

  • Name, address and telephone number of the sponsor.
  • Pharmaceutical form and route of administration.
  • Lot Number.
  • Legend "Exclusively for clinical studies"
  • Date of Expiry.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Travoprost

Arm Intervention/treatment
Experimental: PRO-179
Dosage: 1 drop every 24 hours, at night, in both eyes.
Drug: PRO 179
  • Generic name: Travoprost
  • Distinctive denomination: Bristrio® (PRO-179)
  • Active principles: Travoprost 0.004%.
  • Pharmaceutical form: Ophthalmic solution
  • Presentation: multi-dose dropper bottle, 2.5 milliliters.
  • Prepared by: Sophia Laboratories, S.A. of C.V.
  • Description of the solution: transparent solution, free of visible particles.
  • Description of container: White bottle with 5 milliliters capacity, made of low density polyethylene.
Other Names:
  • PRO-179
  • Bristrio®
  • Travoprost 0.004% ophthalmic solution

Active Comparator: Travatan®
Dosage: 1 drop every 24 hours, at night, in both eyes.
Drug: Travatan 0.004 % Ophthalmic Solution
  • Generic name: Travoprost
  • Distinctive denomination: Travatan®
  • Active ingredients: Travoprost 0.004%
  • Pharmaceutical form: Ophthalmic solution.
  • Presentation: multi-dose dropper bottle, 2.5 milliliters.
  • Prepared by: Alcon Laboratories Inc.
  • Description of the solution: transparent solution, free of visible particles.
  • Consult information to prescribe.
Other Name: Travoprost 0.004% ophthalmic solution




Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.


  3. 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.

  4. 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.


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be clinically healthy.
  • Have the ability to give their signed informed consent and show willingness to comply with the study procedures
  • Have an age between 18 to 45 years.
  • Indistinct sex.
  • Women should ensure the continued use of a hormonal contraceptive method or intrauterine device (IUD) during the study period.
  • Present blood tests: within normal parameters or with a range of ± 20% as long as the subject is clinically healthy.

Blood count (BH): Hemoglobin, erythrocytes, hematocrit, total leukocytes, platelets, mean corpuscular volume and mean corpuscular hemoglobin.

  • Blood chemistry of three elements (QS): Glucose, urea and creatinine.
  • Liver function tests (PFH): Aspartate Aminotransferase and Alanine Aminotransferase, total bilirubin, direct and indirect.

    • Present visual ability 20/30 or better in both eyes.
    • Present vital signs within normal parameters.
    • Present intraocular pressure ≥10 and ≤ 21 mmHg.

Exclusion Criteria:

  • Be a user of topical ophthalmic products of any kind.
  • Be a user of medicines, or herbal products, by any other route of administration, with the exception of hormonal contraceptives in the case of women.
  • In case of being a woman, being pregnant or breastfeeding.
  • Have participated in clinical research studies 90 days prior to inclusion in the present study.
  • Have previously participated in this same study.
  • Be a user of contact lenses and can not suspend their use during the study.
  • That they can not follow the lifestyle considerations described in section 6.2.2
  • Having started the use of hormonal contraceptives or IUD, 30 days prior to inclusion in the present study.
  • Having a history of any chronic-degenerative disease.
  • Present inflammatory or infectious disease, active at the time of admission to the study.
  • Present injuries or unresolved traumas at the time of entering the study.
  • Having the antecedent of any type of eye surgery.
  • Having undergone surgical procedures, not ophthalmological, in the last 3 months.

Information from the National Library of Medicine

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


Locations
Layout table for location information
Mexico
Jose Navarro Partida
Guadalajara, Jalisco, Mexico, 45160
Sponsors and Collaborators
Laboratorios Sophia S.A de C.V.
Investigators
Layout table for investigator information
Study Director: Leopoldo Baiza Durán, MD Laboratorios Sophia S.A de C.V.
  Study Documents (Full-Text)

Documents provided by Laboratorios Sophia S.A de C.V.:
Layout table for additonal information
Responsible Party: Laboratorios Sophia S.A de C.V.
ClinicalTrials.gov Identifier: NCT03965052    
Other Study ID Numbers: SOPH179-0818/I
First Posted: May 28, 2019    Key Record Dates
Results First Posted: December 12, 2019
Last Update Posted: December 12, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laboratorios Sophia S.A de C.V.:
Travoprost
ophthalmic solution
Prostaglandin Analogues
Antiglaucoma drugs
glaucoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Glaucoma
Ocular Hypertension
Eye Diseases
Travoprost
Pharmaceutical Solutions
Ophthalmic Solutions
Antihypertensive Agents