CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 22 enrolled
Drug / intervention
Naphazoline / Hypromellose Ophthalmicdrug
Likely dose
Naphazoline 0.03% / Hypromellose 0.2% ophthalmic solutionAI-extracted
Key inclusion· 5
  • ✓Age 18–45 years
  • ✓Clinically healthy with no chronic illness
  • ✓Best corrected visual acuity ≥20/30 in both eyes
  • ✓Intraocular pressure between 10 and 21 mmHg
Key exclusion· 12
  • ✕History of angle closure glaucoma or iridotomy
  • ✕Allergies to naphazoline or intolerance to nasal decongestants or ocular vasoconstrictive products
  • ✕Conjunctival hyperemia grade 3 or 4 on Efron scale
  • ✕Ocular surface staining ≥3 on SICCA scale in either eye

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05470868
NCT05470868Phase 1Completed
CompareCT.gov

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

Laboratorios Sophia S.A de C.V.·interventional·Posted Jul 22, 2022·Updated Jul 17, 2025

In Brief

A Phase 1 clinical trial evaluating Naphazoline / Hypromellose Ophthalmic for Hyperemia Eye. Completed, enrolled 22 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperemia Eye
CountriesMexico
Collaborators--

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedJul 22, 2022
Enrollment StartFeb 4, 2023
Primary CompletionMay 22, 2023
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 3.9 years ago

Interventions

Naphazoline / Hypromellose Ophthalmicdrug

Naphazoline 0.03% / Hypromellose 0.2%