Study to Evaluating PRO-240 Ophthalmic Solution Compared to Optive®
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 evaluating safety and tolerability of PRO-240 ophthalmic solution through the incidence of unexpected adverse events, as well as through changes in Best Corrected Visual Acuity (BCVA), and the incidence of stinging after its administration, compared to Optive®.
Eligibility criteria
Qualifiers
Having the ability to voluntarily give their signed informed consent.
Ophthalmologically and 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.
Use of non-steroidal anti-inflammatory drugs, steroid anti-inflammatory drugs, or antibiotics by any route of administration in the last 30 days.
Trial design
Treatments tested in this trial
- PRO-240
- Optive®
Treatment groups
32 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov