Safety and Tolerability of PRO-185

Laboratorios Sophia

Status and phase

Completed

Phase 1

Conditions

Hyperemia Eye

Treatments

Drug: Naphazoline / Hypromellose Ophthalmic

Study type

Interventional

Funder types

Industry

Identifiers

NCT05470868

SOPH185-0521/I

Details and patient eligibility

About

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.

Full 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.

Enrollment

22 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.