Safety and Tolerability of PRO-185

NCT05470868 | Completed Phase 1 Results DMC

• 1 other identifier: SOPH185-0521/I
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperemia Eye

Outcome Measures

Primary Outcomes (6)

• Intraocular Pressure (IOP) Increment

  Safety evaluation through the incidence of subjects presenting an IOP elevation comparing Baseline Visit, Final Visit and before and after (20 minutes) research product administration (V1 and V2). Only right-eye values were analyzed.

  Baseline visit (BV), day 1(pre and post pupil dilation); Visit 1 (V1), day 3 +1 (pre and post research product application); Visit 2 (V2), 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 (Systolic)

  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). A higher score (grades) in this scale translates into worse outcomes. Only right-eye values were analyzed.

  Trough Day 10 (+1)

• Incidence of Pharmacological Mydriasis

  Incidence of pharmacological mydriasis measured through OPD III scan. If there was a change greater than 2 mm in pupil diameter between the baseline visit and any of the other measurements, pharmacological mydriasis was considered present, also if there was this change between the pre- and post-examination of the investigational product during visits 1 and 2.

  Trough Day 10 (+1)

• Blood Pressure Increment (Diastolic)

  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)

Study Arms (1)

PRO-185

EXPERIMENTAL

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

Interventions

Naphazoline / Hypromellose Ophthalmic DRUG

Naphazoline 0.03% / Hypromellose 0.2%

PRO-185

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 this study.
• Using contact lenses which cannot be suspended during the period of this study.
• History of any chronic illness, including diabetes and hypertension.
• History of any kind of ocular surgery.

Sponsors & Collaborators

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

Study Sites (1)

IIMET Investigación e Innovación en Medicina Translacional

Guadalajara, Jalisco, 44650, Mexico

Location

MeSH Terms

Interventions

Naphazoline

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Alejandra Sanchez-Ríos M.D.
• Organization: Laboratorios Sophia

alejandra.sanchez@sophia.com.mx

:+52 (33) 3001 4200

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase I, controlled, non-comparative, single-center, open study.

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: July 22, 2022
• Study Start: February 4, 2023
• Primary Completion: May 22, 2023
• Study Completion: May 22, 2023
• Last Updated: July 17, 2025
• Results First Posted: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)