Safety and Tolerability of PRO-185 (PRO-185)

Phase I Clinical Study, to Evaluate the Safety and Tolerability of the Ophthalmic Solution PRO-185 When Applied on the Ocular Surface of Healthy Volunteers

Phase I Study to evaluate safety and tolerability of PRO-185 (naphazoline/hypromellose) ophthalmic solution through evaluation of vital signs, ocular signs such as intraocular pressure, hyperemia and mydriasis and adverse events.

Study Overview

• Status: Completed
• Conditions: Hyperemia Eye
• Intervention / Treatment: Drug: Naphazoline / Hypromellose Ophthalmic

Detailed Description

A total of 22 healthy volunteers will apply PRO-185 ocular solution on both eyes QID (four times per day) for 8 days. The safety variables will include intraocular pressure, heart rate, systolic and diastolic blood pressure. Tolerability variables will include: hyperemia, mydriasis, and expected and unexpected adverse events. The presence of any of these in ≤ 20% will deem PRO-185 as safe and tolerable.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Alejandra Sanchez-Rios, MD; Phone Number: 1190 +52 3330014200; Email: alejandra.sanchez@sophia.com.mx

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44650
      • IIMET Investigación e Innovación en Medicina Translacional

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Being clinically healthy
• Having the ability to grant a signed informed consent
• Being able and willing to comply with the programmed visits, treatment plan and other procedures of this study.
• Age between 18 and 45 years
• Women in child-bearing age must assure the continuation (start ≥ 30 days previous to the signing of the ICF) of a hormonal contraceptive method or a intrauterine device (IUD) during the period of the study.
• Best corrected visual acuity equal of better than 20/30 in both eyes.
• Vital signs within normal ranges.
• Intraocular pressure ≥10 and ≤ 21 mmHg

Exclusion Criteria:

• Using any kind of topic ophthalmic products
• Presenting allergies to naphazoline or the history of intolerance to nasal decongestants or ocular vasoconstrictive products.
• History of diagnosis of suspicion of primary angle closure, primary angle closure or closed angle glaucoma.
• History of iridotomies or waiting for this procedure to take place.
• Conjunctival hyperemia grade 3 or 4 according to Efron scale.
• Ocular surface staining equal or greater to 3 in the SICCA scale, for any eye.
• Using medications or herbology products, through any route of administration.
• Pregnant, breastfeeding or women who plan to get pregnant during the period of the study.
• Previous participation in any clinical study 90 days prior to the inclusion in the present study.
• Previous participation in this study.
• Using contact lenses which cannot be suspended during the period of this study.
• History of any chronic illness, including diabetes and hypertension.
• Active inflammation or infection at the time of inclusion in this study.
• Unresolved lesions or traumas at the moment of inclusion in this study.
• History of any kind of ocular surgery.
• History of any surgical procedure, non-ophthalmologic, within the previous 3 months to the inclusion in this study.

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-185; Healthy volunteers will apply one drop of PRO-185 ophthalmic solution (naphazoline / hypromellose) on both eyes, QID (four times per day) for 8 days.	Drug: Naphazoline / Hypromellose Ophthalmic; Naphazoline 0.03% / Hypromellose 0.2%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular pressure increment	Safety evaluation through the incidence of subjects presenting an elevation > 5 mmHg in intraocular pressure 20 minutes after administration, in comparison to baseline value.	Baseline visit, day 1(pre and post pupil dilation); Visit 1, day 3 +1 (pre and post research product application); Visit 2, day 8 (pre and post research product application); Final Visit, day 10 (+1)
Heart rate increment	Safety evaluation through the incidence of subjects presenting an elevation > 15 beats per minute 20 minutes after administration, in comparison to baseline value.	Baseline visit, day 1(pre and post pupil dilation); Visit 1, day 3 +1 (pre and post research product application); Visit 2, day 8 (pre and post research product application); Final Visit, day 10 (+1)
Blood pressure increment	Safety evaluation through the incidence of subjects presenting an elevation > 15 mmHg in systolic pressure or > 10 mmHg in diastolic pressure 20 minutes after administration, in comparison to baseline value.	Baseline visit, day 1(pre and post pupil dilation); Visit 1, day 3 +1 (pre and post research product application); Visit 2, day 8 (pre and post research product application); Final Visit, day 10 (+1)
Incidence of Conjunctival Hyperemia	Tolerability evaluation through the incidence of conjunctival hyperemia grades 3 and 4 (according to the Efron scale).	Trough Day 10 (+1)
Incidence of Pharmacological Mydriasis	Tolerability evaluation through the incidence of pharmacological mydriasis measured through OPD III scan (considered as a difference > 2 mm compared to the baseline value).	Trough Day 10 (+1)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2023
• Primary Completion (Actual): May 22, 2023
• Study Completion (Actual): May 22, 2023

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 (Estimated): December 12, 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: Cardiovascular Diseases; Vascular Diseases; Hyperemia; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic alpha-Agonists; Adrenergic Agonists; Respiratory System Agents; Vasoconstrictor Agents; Nasal Decongestants; Naphazoline
• Other Study ID Numbers: SOPH185-0521/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