Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface.

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorLaboratorios Sophia S.A de C.V.

About this trial

This is a phase I clinical study to evaluate the safety and tolerability of PRO-190 ophthalmic solution through the incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), changes in ocular surface integrity, changes in the ocular comfort index (OCI) score, and IOP measurement compared to Systane Ultra®.

Eligibility criteria

Qualifiers

Having the ability to voluntarily give their signed informed consent.

Clinically healthy subjects.

Being able to and willing to comply with scheduled visits, treatment plan, and other study procedures.

Age ≥ 18 years.

Disqualifiers

History of hypersensitivity to any of the components of the drugs under investigation.

Use of ophthalmic medications from any pharmacological group.

Use of medications by any other route of administration.

In the case of women: being pregnant, breastfeeding, or planning to become pregnant within the study period.

Trial design

Treatments tested in this trial

  • PRO-190
  • Systane Ultra®

Treatment groups

32 Participants
are divided into 2 treatment groups

Locations

This trial has no locations