Clinical trial NCT05470881: Phase I Clinical Trial to Evaluate the Safety and Tolerability of Ophtalmic Solution 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Myopia
Lead sponsor: Laboratorios Sophia S.A de C.V.
Sponsor class: INDUSTRY
First posted: 2022-07-22
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Phase I, controlled, non-comparative, open, unicentric study.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence of unexpected adverse events
timeFrame: Through Day 21 ± 1 (Safety Call)
measure: Incidence of photophobia
timeFrame: Through Day 21 ± 1 (Safety Call)
Secondary outcomes:
measure: Pupillary Diameter
timeFrame: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
measure: Incidence of expected adverse events
timeFrame: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit), 21 ± 1 (Safety Call)
measure: Measurement of the change in best near corrected visual acuity (BNCVA)
timeFrame: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
Other outcomes:
measure: Measurement of the change in best corrected visual acuity (BCVA)
timeFrame: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
measure: Changes in intraocular pressure (IOP)
timeFrame: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
measure: Incidence of corneal and conjunctival staining
timeFrame: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
measure: Measurement of vital signs (blood pressure)
timeFrame: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
measure: Measurement of vital signs (heart rate)
timeFrame: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
measure: Value of the ocular comfort index (OCI) questionnaire.
timeFrame: Days: 1 (Basal Visit), 16 ± 1 (Final Visit)
Locations:
city: Guadalajara
country: Mexico
facility: IIMET Investigación e Innovación en Medicina Traslacional
state: Jalisco
Study officials:
References: