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

Myopia Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05470881
• Other study ID #: SOPH201-0521/I
• Status: Completed
• Phase: Phase 1
• Start date: August 20, 2022
• Est. completion date: December 26, 2022

Study information

• Verified date: December 2023
• Source: Laboratorios Sophia S.A de C.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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),

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 26, 2022
• Est. primary completion date: December 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Drug:
• Atropine Sulfate
Administration of one drop QD on both eyes for 14 days.

Locations

Country	Name	City	State
Mexico	IIMET Investigación e Innovación en Medicina Traslacional	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Sophia S.A de C.V.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Primary	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)
Primary	Incidence of photophobia	The number of cases of photophobia.	Through Day 21 ± 1 (Safety Call)
Secondary	Pupillary Diameter	Measurement of pupillary diameter after exposure to the investigation product.	Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
Secondary	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)
Secondary	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)