NCT05470868

Safety and Tolerability of 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Laboratorios Sophia S.A de C.V. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Hyperemia Eye

Interventions

Type	Name	Description
DRUG	Naphazoline / Hypromellose Ophthalmic	Naphazoline 0.03% / Hypromellose 0.2%

Timeline

• Start date: 2023-02-04
• Primary completion: 2023-05-22
• Completion: 2023-05-22
• First posted: 2022-07-22
• Last updated: 2025-07-17
• Results posted: 2025-07-17

Locations

1 site across 1 country: Mexico