Clinical Trial for the Evaluation of the Safety and Efficacy of a Moisturizing Solution With Hyaluronic Acid Drop 0.4% (DROP04)

NCT06985875 Phase 3 NOT_YET_RECRUITING

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.

Details

Lead sponsor	Avizor SA
Phase	Phase 3
Status	NOT_YET_RECRUITING
Enrolment	79
Start date	2025-07
Completion	2025-12-31

Conditions

• Eye Dryness

Interventions

• Multidose mosturizing solution DROP 0.4%
• Multidose mosturizing solution Avizor Eye Drops 0.2% Preserved

Primary outcomes

• Changes in eye dryness symptoms — 1 month
  Changes in ocular symptoms (measured with Contact lens dry eye questionnaire and/or change in the frequency and intensity of dry eye symptoms (measured with a Visual analogue scale from 0 to 10). For contact lens users
• Changes in eye dryness symptoms — 1 month
  Changes in ocular symptoms (measured with Ocular surface disease index and/or change in the frequency and intensity of dry eye symptoms (measured with a Visual analogue scale from 0 to 10). For non contact lens users
• Changes in best corrected visual acuity (safety outcome) — 1 month
  Best corrected visual acuity tested with ETDRS (early treatment for diabetes retinopathy study).
• Ocular and peri orbital adverse events — 1 month
  All local adverse events reported
• Serious adverse events — 1 month
  All local and systemic serious adverse events