Phase 1
N=22
Safety and Tolerability of PRO-185
Hyperemia Eye
Bottom Line
View on ClinicalTrials.gov: NCT05470868 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Intraocular Pressure (IOP) Increment — 14.00; 13.57; 13.47; 13.25 mmhg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Naphazoline / Hypromellose Ophthalmic (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Laboratorios Sophia S.A de C.V.
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraocular Pressure (IOP) Increment |
14.00; 13.57; 13.47; 13.25; 13.02; 13.65 | — |
| PRIMARY Heart Rate Increment |
73.27; 70.54; 70.59; 70.68; 69.90; 73 | — |
| PRIMARY Blood Pressure Increment (Systolic) |
113.81; 111.00; 111.22; 107.50; 108.63; 113.90 | — |
| PRIMARY Incidence of Conjunctival Hyperemia |
2 | — |
| PRIMARY Incidence of Pharmacological Mydriasis |
6.50 | — |
| PRIMARY Blood Pressure Increment (Diastolic) |
68.36; 68.40; 69.45; 66.59; 67.31; 67.41 | — |
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.
Eligibility 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 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.
Data sourced from ClinicalTrials.gov (NCT05470868). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.