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

Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-201 Ophthalmic Solution Applied on the Ocular Surface of Healthy Volunteers.

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),

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Drug: Atropine Sulfate

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 1

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44610
      • IIMET Investigación e Innovación en Medicina Traslacional

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRO-201; A total of 29 anticipated healthy volunteers will be exposed to the investigation product.	Drug: Atropine Sulfate; Administration of one drop QD on both eyes for 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through Day 21 ± 1 (Safety Call)
Incidence of photophobia	The number of cases of photophobia.	Through Day 21 ± 1 (Safety Call)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pupillary Diameter	Measurement of pupillary diameter after exposure to the investigation product.	Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
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.	Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit), 21 ± 1 (Safety Call)
Measurement of the change in best near corrected visual acuity (BNCVA)	The change in BNCVA after exposure to investigation product, compared to basal value.	Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of the change in best corrected visual acuity (BCVA)	The change in BCVA after exposure to investigation product, compared to basal value.	Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
Changes in intraocular pressure (IOP)	The change in IOP after exposure to investigation product, compared to basal value.	Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
Measurement of vital signs (blood pressure)	The change in blood pressure after exposure to investigation product, compared to basal value.	Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
Measurement of vital signs (heart rate)	The change in heart rate after exposure to investigation product, compared to basal value.	Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
Incidence of corneal and conjunctival staining	Presence of corneal and conjunctival staining with fluorescein and lissamine green after exposure to investigation product.	Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
Value of the ocular comfort index (OCI) questionnaire.	The change ocular comfort index (OCI) questionnaire results after exposure to investigation product, compared to basal value.	Days: 1 (Basal Visit), 16 ± 1 (Final Visit)

Collaborators and Investigators

• Sponsor: Laboratorios Sophia S.A de C.V.

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2022
• Primary Completion (Actual): December 26, 2022
• Study Completion (Actual): December 26, 2022

Study Registration Dates

• First Submitted: March 23, 2022
• First Submitted That Met QC Criteria: July 20, 2022
• First Posted (Actual): July 22, 2022

Study Record Updates

• Last Update Posted (Actual): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Mydriatics; Atropine
• Other Study ID Numbers: SOPH201-0521/I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No