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Safety and Tolerability of the Ophthalmic Gel PRO-167 Versus Corneregel® on Healthy Subjects. (PRO-167/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: NCT03520348
Recruitment Status : Completed
First Posted : May 9, 2018
Results First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Laboratorios Sophia S.A de C.V.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Dry Eye Dry Eye Syndrome of Unspecified Lacrimal Gland Drug: PRO-167 Drug: Corneregel Phase 1

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

The blinding will correspond to the research subject and the principal investigator. In addition, the statistical analysis will be carried out in a blinded manner for the partial and final analysis.

The masking will be done using boxes in the primary packaging identical in the two groups. Blinding for the research subject and the researcher will be done by replacing the commercial labels in the case of the comparator in the bottles and the use of identical labels that contain the allocation number.

Blinding may be opened in the following cases:

  1. Presence of a serious adverse event.
  2. Safety alarm due to the use of the drugs under study.
  3. In case the sponsor determines it for any reason of security or other reason that considers pertinent.
Primary Purpose: Treatment
Official 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.
Actual Study Start Date : October 4, 2017
Actual Primary Completion Date : May 22, 2018
Actual Study Completion Date : July 16, 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: PRO-167
Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom
 Drug: PRO-167

Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico.

Route of administration: ophthalmic

Other Name: dexpanthenol
Active Comparator: 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.
 Drug: Corneregel
Dexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin, Germany. Route of administration: ophthalmic
Other Name: dexpanthenol


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Presence of Adverse Events (EAS) [ Time Frame: during the 11 days of evaluation, including the safety call (day 13). ]
    the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent.

  2. Intraocular Pressure (IOP) [ 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

  3. Breakup Time (BUT) [ Time Frame: will be evaluated at the end of the treatment at the final visit (day 11) ]
    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.

  4. 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.

  5. Ocular Burning (OB) [ Time Frame: will be evaluated at the end of the treatment at the final visit (day 11) ]
    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.

  6. Epithelial Defects (ED) [ 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, 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.

  7. Conjunctival Hyperemia (CH) [ 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.

  8. Foreign Body Sensation (FBS) [ Time Frame: will be evaluated at the end of the treatment at the final visit (day 11) ]

    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.


  9. Ocular Pruritus (P) [ Time Frame: will be evaluated at the end of the treatment at the final visit (day 11) ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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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): NCT03520348


Locations
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Mexico
Centro Oftalmológico San Angel
Guadalajara, Jalisco, Mexico, 44200
Sponsors and Collaborators
Laboratorios Sophia S.A de C.V.
Investigators
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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.:
Study Protocol and Statistical Analysis Plan  [PDF] August 8, 2016

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Laboratorios Sophia S.A de C.V.
ClinicalTrials.gov Identifier: NCT03520348    
Other Study ID Numbers: SOPH167-0816/I
First Posted: May 9, 2018    Key Record Dates
Results First Posted: July 19, 2019
Last Update Posted: July 19, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.:
dry eye
eye lubricants
eye lubricant gel
PRO-167
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
 Keratitis
Corneal Diseases
Pantothenic Acid
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs