Safety and Tolerability of PRO-185 | Clinical Trial

Key information

Conditions

Hyperemia Eye

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

IIMET Investigación e Innovación en Medicina Translacional

Guadalajara, Jalisco, 44650, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Naphazoline / Hypromellose Ophthalmic

Drug

Naphazoline 0.03% / Hypromellose 0.2%

Primary outcomes

Intraocular Pressure (IOP) Increment

Time frame: 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)

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.
Heart Rate Increment

Time frame: 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)

Safety evaluation through the incidence of subjects presenting an elevation > 15 beats per minute 20 minutes after administration, in comparison to baseline value.
Blood Pressure Increment (Systolic)

Time frame: 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)

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.
Incidence of Conjunctival Hyperemia

Time frame: Trough Day 10 (+1)

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.
Incidence of Pharmacological Mydriasis

Time frame: Trough Day 10 (+1)

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.
Blood Pressure Increment (Diastolic)

Time frame: 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)

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.

Sponsors and collaborators

Lead sponsor

Laboratorios Sophia S.A de C.V.

Industry

Registry information

Official study title

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

Acronym: PRO-185

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Jul 22, 2022
Registry last updated: Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.