Ssafety and Tolerability of PRO-185

• Status: Not yet recruiting
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Laboratorios Sophia S.A de C.V.
• Treatments: Naphazoline

Criteria

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 medicantions or herbolary 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.