Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • Multidose mosturizing solution DROP 0.4%

    Device

    Ophthalmic mosturizing solution to be administered 1-4 times per day in both eyes

  • Multidose mosturizing solution Avizor Eye Drops 0.2% Preserved

    Device

    Ophthalmic mosturizing solution to be administered 1-4 times per day in both eyes

Treatment groups

79 Participants
are divided into 2 treatment groups
Group A: Contact lens users with eye drynessOther 2 interventions
Group B: Non contact lens user with eye drynessOther 2 interventions

Trial outcomes

Primary outcomes

1

Changes in eye dryness symptoms

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

Time frame
1 month
2

Changes in eye dryness symptoms

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

Time frame
1 month
3

Changes in best corrected visual acuity (safety outcome)

Best corrected visual acuity tested with ETDRS (early treatment for diabetes retinopathy study).

Time frame
1 month
4

Ocular and peri orbital adverse events

All local adverse events reported

Time frame
1 month

Secondary outcomes

1

Stability of the tear film

Measurement of tear film stability by Non-Invasive Break-Up Time (NIBUT).

Time frame
1 month
2

Ocular surface response to treatment - Oxford Scale (0 (Better) to 5 (Worse))

Corneal staining with fluorescein, green lissamine and conjunctival hyperemia

Time frame
1 month
3

Tear evaporation

Assessed by evaporimetry

Time frame
1 month
4

Number of instillations per product

Comparison between the number of intimations of both products

Time frame
1 month

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Avizor SA

Lead sponsor

Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: