Clinical Trial for the Evaluation of Safety and Efficacy of Drop 0.4%
ConditionEye Dryness
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-99
SponsorAvizor SA
About this trial
The aim of the trial is to compare the safety and efficacy of the moisturizing solution DROP 0.4% with the moisturizing solution AVIZOR EYE DROPS 0.2% PRESERVED in relieving the symptoms of dry eye over one month of use.
Eligibility criteria
Qualifiers
Male or female, aged 18 years or older, capable of freely providing informed consent for participation in the study.
Signed informed consent form prior to any study-related tests.
Signed data protection form prior to any study-related tests.
Ocular surface disease index (OSDI) ≥ 13
Disqualifiers
Any active ocular surface disease except for dry eye disease.
Corneal fluorescein staining ≥ 4 on the Oxford scale (0-5).
Conjunctival lissamine green staining ≥ 4 on the Oxford scale (0-5).
Schirmer test value ≤ 2 mm.
Trial design
Treatments tested in this trial
- Multidose mosturizing solution DROP 0.4%
- Multidose mosturizing solution Avizor Eye Drops 0.2% Preserved
Treatment groups
79 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Avizor SA
Lead sponsor
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Collaborator
Source ClinicalTrials.gov