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Phase I Clinical Trial to Evaluate the Safety and Tolerability of Ophtalmic Solution PRO-201 (PRO-201)

Primary Purpose

Myopia

Status
Recruiting
Phase
Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
Atropine Sulfate
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 Myopia

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Being clinically healthy
  • Ability to voluntarily sign an informed consent form (ICF).
  • Ability and willingness to comply with the scheduled visits according to the intervention plan and other procedures of the study.
  • Age between 18 and 35.
  • Absence of history of contact lens use.
  • Women of childbearing age must agree to continue (starting ≥ 30 days previous to the ICF) the use of a hormonal contraception method of a intrauterine device (IUD) during the period of the study.
  • Best corrected visual acuity (BVCA) of at least 20/30 (logMAR 0.2) or better in both eyes.
  • Best near corrected visual acuity (BNVCA) of at least 20/25 (logMAR 0.1) or better in both eyes.
  • Presenting vital signs within normal parameters.
  • Presenting an IOP ≥10 and ≤ 21 mmHg

Exclusion Criteria:

  • Using any kind of ophthalmic topical products.
  • Presenting known allergy or intolerance to any ingrediente of atropine eyedrops or any other derivatives of antimuscarinic agents.
  • Using any medication of herbolary products (plant extracts, infusions, naturist preparations, homeopathy, etc) through any route of administration
  • For women: being pregnant, breastfeeding or planning to get pregnant during the period of the study.
  • Having participated in any clinical study 90 days prior to the inclusion in this study.
  • Having participated in this clinical study.
  • Inability to follow the lifestyle considerations of this study.
  • History of any chronic degenerative disease, including diabetes and hypertension.
  • Presenting active inflammatory or infectious diseases when entering this study.
  • Presenting unresolved lesions or trauma when entering this study.
  • History of any ocular surgery.
  • History of any surgery, non-ocular, within the previous 3 months of entering this studies.
  • Being or having an direct family member (spouse, parent/legal guardian, sibling, etc) as employee of the investigation site or the sponsor, who participates directly in this study.

Elimination criteria:

  • Withdraw of ICF.
  • Adverse event, related or not to the investigation product, that according to the principal investigator and/or the sponsor may affect the integrity of the patient to continue safely with the study's procedures.
  • Hypersensitivity or lack of tolerance to any of the ingredients used during the study's procedures (fluorescein, lissamine green, tetracaine, etc)
  • Hypersensitivity or lack of tolerance to the investigation product.
  • Presenting an adherence to treatment < 90%, as determined through the subjects diary.

Sites / Locations

  • IIMET Investigación e Innovación en Medicina TraslacionalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PRO-201

Arm Description

A total of 29 anticipated healthy volunteers will be exposed to the investigation product.

Outcomes

Primary Outcome Measures

Incidence of unexpected adverse events
The number of adverse events presented that are not previously described / known for the active substance in this pharmaceutic form and concentration.
Incidence of photophobia
The number of cases of photophobia.

Secondary Outcome Measures

Pupillary Diameter
Measurement of pupillary diameter after exposure to the investigation product.
Incidence of expected adverse events
The number of adverse events presented that are not previously described / known for the active substance in this pharmaceutic form and concentration.
Measurement of the change in best near corrected visual acuity (BNCVA)
The change in BNCVA after exposure to investigation product, compared to basal value.

Full Information

First Posted
March 23, 2022
Last Updated
December 26, 2022
Sponsor
Laboratorios Sophia S.A de C.V.
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1. Study Identification

Unique Protocol Identification Number
NCT05470881
Brief Title
Phase I Clinical Trial to Evaluate the Safety and Tolerability of Ophtalmic Solution PRO-201
Acronym
PRO-201
Official Title
Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-201 Ophthalmic Solution Applied on the Ocular Surface of Healthy Volunteers.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2022 (Actual)
Primary Completion Date
January 15, 2023 (Anticipated)
Study Completion Date
January 15, 2023 (Anticipated)

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
Evaluation of the safety and tolerability of PRO-201 (0.01% sulfate atropine) after its instillation on the ocular surface of healthy volunteers through the following variables: unexpected adverse events incidence and photophobia (primary outcome variables); as well as pupillary diameter, expected adverse events incidence, best near corrected visual acuity (BNCVA), best corrected visual acuity (BCVA), intraocular pressure (IOP), corneal and conjunctival staining, heart rate, blood pressure and ocular confort index (OCI),
Detailed Description
A total of 29 healthy volunteers will be enrolled in this study. They will receive one drop of the investigation product PRO-201 (0.01% atropine sulfate) once a day (QD) for a total of 14 days on both eyes. A final safety call will be performed one week after the last day of product application.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Phase I, controlled, non-comparative, open, unicentric study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PRO-201
Arm Type
Experimental
Arm Description
A total of 29 anticipated healthy volunteers will be exposed to the investigation product.
Intervention Type
Drug
Intervention Name(s)
Atropine Sulfate
Intervention Description
Administration of one drop QD on both eyes for 14 days.
Primary Outcome Measure Information:
Title
Incidence of unexpected adverse events
Description
The number of adverse events presented that are not previously described / known for the active substance in this pharmaceutic form and concentration.
Time Frame
Through Day 21 ± 1 (Safety Call)
Title
Incidence of photophobia
Description
The number of cases of photophobia.
Time Frame
Through Day 21 ± 1 (Safety Call)
Secondary Outcome Measure Information:
Title
Pupillary Diameter
Description
Measurement of pupillary diameter after exposure to the investigation product.
Time Frame
Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
Title
Incidence of expected adverse events
Description
The number of adverse events presented that are not previously described / known for the active substance in this pharmaceutic form and concentration.
Time Frame
Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit), 21 ± 1 (Safety Call)
Title
Measurement of the change in best near corrected visual acuity (BNCVA)
Description
The change in BNCVA after exposure to investigation product, compared to basal value.
Time Frame
Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
Other Pre-specified Outcome Measures:
Title
Measurement of the change in best corrected visual acuity (BCVA)
Description
The change in BCVA after exposure to investigation product, compared to basal value.
Time Frame
Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
Title
Changes in intraocular pressure (IOP)
Description
The change in IOP after exposure to investigation product, compared to basal value.
Time Frame
Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
Title
Incidence of corneal and conjunctival staining
Description
Presence of corneal and conjunctival staining with fluorescein and lissamine green after exposure to investigation product.
Time Frame
Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
Title
Measurement of vital signs (blood pressure)
Description
The change in blood pressure after exposure to investigation product, compared to basal value.
Time Frame
Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
Title
Measurement of vital signs (heart rate)
Description
The change in heart rate after exposure to investigation product, compared to basal value.
Time Frame
Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
Title
Value of the ocular comfort index (OCI) questionnaire.
Description
The change ocular comfort index (OCI) questionnaire results after exposure to investigation product, compared to basal value.
Time Frame
Days: 1 (Basal Visit), 16 ± 1 (Final Visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being clinically healthy Ability to voluntarily sign an informed consent form (ICF). Ability and willingness to comply with the scheduled visits according to the intervention plan and other procedures of the study. Age between 18 and 35. Absence of history of contact lens use. Women of childbearing age must agree to continue (starting ≥ 30 days previous to the ICF) the use of a hormonal contraception method of a intrauterine device (IUD) during the period of the study. Best corrected visual acuity (BVCA) of at least 20/30 (logMAR 0.2) or better in both eyes. Best near corrected visual acuity (BNVCA) of at least 20/25 (logMAR 0.1) or better in both eyes. Presenting vital signs within normal parameters. Presenting an IOP ≥10 and ≤ 21 mmHg Exclusion Criteria: Using any kind of ophthalmic topical products. Presenting known allergy or intolerance to any ingrediente of atropine eyedrops or any other derivatives of antimuscarinic agents. Using any medication of herbolary products (plant extracts, infusions, naturist preparations, homeopathy, etc) through any route of administration For women: being pregnant, breastfeeding or planning to get pregnant during the period of the study. Having participated in any clinical study 90 days prior to the inclusion in this study. Having participated in this clinical study. Inability to follow the lifestyle considerations of this study. History of any chronic degenerative disease, including diabetes and hypertension. Presenting active inflammatory or infectious diseases when entering this study. Presenting unresolved lesions or trauma when entering this study. History of any ocular surgery. History of any surgery, non-ocular, within the previous 3 months of entering this studies. Being or having an direct family member (spouse, parent/legal guardian, sibling, etc) as employee of the investigation site or the sponsor, who participates directly in this study. Elimination criteria: Withdraw of ICF. Adverse event, related or not to the investigation product, that according to the principal investigator and/or the sponsor may affect the integrity of the patient to continue safely with the study's procedures. Hypersensitivity or lack of tolerance to any of the ingredients used during the study's procedures (fluorescein, lissamine green, tetracaine, etc) Hypersensitivity or lack of tolerance to the investigation product. Presenting an adherence to treatment < 90%, as determined through the subjects diary.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alejandra Sanchez-Rios, MD
Phone
+52 33 3001 4200
Ext
1190
Email
alejandra.sanchez@sophia.com.mx
Facility Information:
Facility Name
IIMET Investigación e Innovación en Medicina Traslacional
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44610
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandro González, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Phase I Clinical Trial to Evaluate the Safety and Tolerability of Ophtalmic Solution PRO-201

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