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Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution (PRO-037)

Primary Purpose

Dry Eye

Status
Completed
Phase
Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
lagricel ofteno multidose
lagricel ofteno single dose
Sponsored by
Laboratorios Sophia S.A de C.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring Dry eye, eye lubricant, sodium hyaluronate

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • To be clinically healthy
  • To have the ability to voluntarily grant your signed informed consent
  • To have the willingness to comply with scheduled visits treatment plan and other study procedures
  • Women in reproductive age should ensure the continuation (initiated ≥ 30 days prior to the signing of the informed consent) to use a hormonal contraceptive method or intrauterine device during the study period.
  • To have a better corrected visual acuity of 20/30 or better in both eyes.
  • To have vital signs in normal parameters.
  • To have an intraocular pressure between ≥10 and ≤ 21 mmHg.

Exclusion Criteria:

  • To be user of ophthalmic topical products of any kind.
  • To be user of medicines, or herbal products, by any other route of administration.
  • In the case of women: being pregnant, breastfeeding or planning to get pregnant in the study period.
  • Having participated in clinical research studies 90 days prior to inclusion in this study.
  • Having previously participated in this same study.
  • To be a user of contact lenses and can not suspend their use during the study.
  • Having initiated the use of hormonal contraceptives or intrauterine devices, 30 days prior to inclusion in the present study.
  • To have a history of any chronic degenerative disease.
  • Having inflammatory or infectious disease, active at the time of admission to the study.
  • Having injuries or unresolved injuries at the time of admission to the study.
  • Having a history of any type of eye surgery.
  • Having undergone surgical procedures, not ophthalmological, in the last 3 months.
  • To be or to have an immediate family member (for example: spouse, parent / legal guardian, brother or child) who is part of the research site staff or the sponsor who participates directly in this study.

Sites / Locations

  • Biomedical research G & LS de RL de CV

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lagricel® Ofteno Multidose

Lagricel® Ofteno Single dose

Arm Description

Lagricel® Ofteno Multidose 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia

Lagricel® Ofteno single dose. 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia

Outcomes

Primary Outcome Measures

Presence of Adverse Events (AEs)
the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent
Eye Comfort Index (ECI)
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

Visual Acuity (VA)
Visual acuity (VA) is a test of visual function. It will be evaluated at baseline, without refractive correction with the Snellen chart.Which will be located in a place with adequate lighting, natural or artificial and at a distance of 3meters from the subject to be evaluated. The snellen chart consists of a booklet with 11 lines composed of letters, each line has a different size and a different weighting. the subject is placed at a safe distance and the contralateral eye to which it will be evaluated is covered, then the examiner detects until the line can clearly see the letters given he or she a score, the normal score for a VA is 20/20.
Epithelial Defects (ED) Fluorescein Stain
The epithelial defects will be evaluated by means of two stains, green lysine 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.
Epithelial Defects (ED) Green Lissamine
The epithelial defects will be evaluated by means of two stains, green lysine 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.
Conjunctival Hyperemia (CH)
Conjunctival hyperemia will be evaluated as an ordinal variable, by direct observation and staged using the Efron scale as 0.-Normal / 1.-Very Light/ 2.- Light/ 3.-Mild / 4.-Moderate / 5.- Severe. Based on this scale, the normal and mild stages are considered without pathologies or normal. Mild, moderate and severe are considered pathological.
Chemosis
It is defined as conjunctival edema, the result of an inflammatory reaction. It is qualified as present or absent. The evaluator will use a narrow beam of light at 60 ° and will measure if the conjunctiva separates from the sclera by ≥ 1/3 of the total eyelid opening

Full Information

First Posted
September 4, 2019
Last Updated
March 31, 2021
Sponsor
Laboratorios Sophia S.A de C.V.
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1. Study Identification

Unique Protocol Identification Number
NCT04081610
Brief Title
Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution
Acronym
PRO-037
Official Title
Phase I Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution Compared to Lagricel® Ofteno Single Dose on the Ocular Surface of Clinically Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 9, 2019 (Actual)
Primary Completion Date
October 23, 2019 (Actual)
Study Completion Date
November 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Sophia S.A de C.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Study design: Phase I clinical trial, single-center, controlled, parallel group, open, randomized. Number of subjects: n = 34 evaluable subjects, 17 evaluable subjects per group (both eyes). Estimated duration of the study: 5 months Therapeutic indication: Eye lubricant Use: Dry Eye Objective:To evaluate the safety and tolerability of Lagricel® Ofteno multidose manufactured by Laboratorios Sophia on the ocular surface of clinically healthy subjects. Hypothesis: H0 = Lagricel® Ofteno multidose ophthalmic solution has a safety and tolerability profile similar to Lagricel® Ofteno single dose in healthy subjects. H1 = Lagricel® Ofteno multidose ophthalmic solution has a different safety and tolerability profile than Lagricel® Ofteno single dose in healthy subjects. Main inclusion criteria: Clinically healthy subjects

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
Dry eye, eye lubricant, sodium hyaluronate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
single-center, controlled, parallel group, open, randomized
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lagricel® Ofteno Multidose
Arm Type
Experimental
Arm Description
Lagricel® Ofteno Multidose 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia
Arm Title
Lagricel® Ofteno Single dose
Arm Type
Active Comparator
Arm Description
Lagricel® Ofteno single dose. 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia
Intervention Type
Drug
Intervention Name(s)
lagricel ofteno multidose
Other Intervention Name(s)
sodium hyaluronate 0.4%
Intervention Description
Dosage: 1 drop 4 times a day per 7 days, both eyes Route of administration: Ophthalmic
Intervention Type
Drug
Intervention Name(s)
lagricel ofteno single dose
Other Intervention Name(s)
sodium hyaluronate 0.4%
Intervention Description
Dosage: 1 drop 4 times a day per 7 days, both eyes Route of administration: Ophthalmic
Primary Outcome Measure Information:
Title
Presence of Adverse Events (AEs)
Description
the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent
Time Frame
during the 10 days of evaluation, including the safety call (day 11).
Title
Eye Comfort Index (ECI)
Description
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).
Time Frame
will be evaluated at the end of the treatment (day 8, final visit)
Secondary Outcome Measure Information:
Title
Visual Acuity (VA)
Description
Visual acuity (VA) is a test of visual function. It will be evaluated at baseline, without refractive correction with the Snellen chart.Which will be located in a place with adequate lighting, natural or artificial and at a distance of 3meters from the subject to be evaluated. The snellen chart consists of a booklet with 11 lines composed of letters, each line has a different size and a different weighting. the subject is placed at a safe distance and the contralateral eye to which it will be evaluated is covered, then the examiner detects until the line can clearly see the letters given he or she a score, the normal score for a VA is 20/20.
Time Frame
will be evaluated at the end of the treatment (day 8, final visit)
Title
Epithelial Defects (ED) Fluorescein Stain
Description
The epithelial defects will be evaluated by means of two stains, green lysine 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.
Time Frame
will be evaluated at the end of the treatment (day 8, final visit)
Title
Epithelial Defects (ED) Green Lissamine
Description
The epithelial defects will be evaluated by means of two stains, green lysine 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.
Time Frame
will be evaluated at the end of the treatment (day 8, final visit)
Title
Conjunctival Hyperemia (CH)
Description
Conjunctival hyperemia will be evaluated as an ordinal variable, by direct observation and staged using the Efron scale as 0.-Normal / 1.-Very Light/ 2.- Light/ 3.-Mild / 4.-Moderate / 5.- Severe. Based on this scale, the normal and mild stages are considered without pathologies or normal. Mild, moderate and severe are considered pathological.
Time Frame
will be evaluated at the end of the treatment (day 8, final visit)
Title
Chemosis
Description
It is defined as conjunctival edema, the result of an inflammatory reaction. It is qualified as present or absent. The evaluator will use a narrow beam of light at 60 ° and will measure if the conjunctiva separates from the sclera by ≥ 1/3 of the total eyelid opening
Time Frame
will be evaluated at the end of the treatment (day 8, final visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: To be clinically healthy To have the ability to voluntarily grant your signed informed consent To have the willingness to comply with scheduled visits treatment plan and other study procedures Women in reproductive age should ensure the continuation (initiated ≥ 30 days prior to the signing of the informed consent) to use a hormonal contraceptive method or intrauterine device during the study period. To have a better corrected visual acuity of 20/30 or better in both eyes. To have vital signs in normal parameters. To have an intraocular pressure between ≥10 and ≤ 21 mmHg. Exclusion Criteria: To be user of ophthalmic topical products of any kind. To be user of medicines, or herbal products, by any other route of administration. In the case of women: being pregnant, breastfeeding or planning to get pregnant in the study period. Having participated in clinical research studies 90 days prior to inclusion in this study. Having previously participated in this same study. To be a user of contact lenses and can not suspend their use during the study. Having initiated the use of hormonal contraceptives or intrauterine devices, 30 days prior to inclusion in the present study. To have a history of any chronic degenerative disease. Having inflammatory or infectious disease, active at the time of admission to the study. Having injuries or unresolved injuries at the time of admission to the study. Having a history of any type of eye surgery. Having undergone surgical procedures, not ophthalmological, in the last 3 months. To be or to have an immediate family member (for example: spouse, parent / legal guardian, brother or child) who is part of the research site staff or the sponsor who participates directly in this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leopoldo Baiza Durán, MD
Organizational Affiliation
Laboratorios Sophia S.A de C.V.
Official's Role
Study Director
Facility Information:
Facility Name
Biomedical research G & LS de RL de CV
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
45070
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Laboratorios Sophia, S.A. de C.V., serving as the sponsor of the study, assumes full responsibility for its function and retains exclusive ownership rights over the results of the study. The principal investigator undertakes not to publish or communicate data collected from the study, unless there is prior written agreement of Laboratorios Sophia, S.A. de C.V.
Citations:
PubMed Identifier
34707360
Citation
Munoz-Villegas P, Navarro-Sanchez AA, Sanchez-Rios A, Olvera-Montano O, Baiza-Duran LM. Reexamining Ophthalmic Drugs, Safety and Tolerability in Phase 1 Clinical Trials. Ther Clin Risk Manag. 2021 Oct 21;17:1123-1134. doi: 10.2147/TCRM.S331294. eCollection 2021.
Results Reference
derived

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Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution

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