This study is a multicentric, comparative, randomized, investigator-blinded, in parallel groups study to demonstrate the non-inferiority of Neovis® Total Multi in comparison with Systane® Balance, in terms of improvement of stability of Tear film in patients with eye dryness associated to meibomian gland dysfunction, after 28 days of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
1 drop in each eye, 4 times per day
1 drop in each eye, 4 times per day
Tear-Film Break Up Time (TBUT)
Evaluation of the non-inferiority of Neovis® Total Multi in comparison with Systane® Balance, in terms of TBUT improvement, on worse eye
Time frame: 28 days
Tear-Film Break Up Time (TBUT) (performance)
Main change from baseline of Tear-Film Break Up Time (TBUT) in the worse eye and contralateral eye
Time frame: 84 days
Cornea and conjunctiva staining (Oxford score) (performance)
Main change from baseline of cornea and conjunctiva staining (Oxford score) in the worse eye and contralateral eye
Time frame: 28 days
Cornea and conjunctiva staining (Oxford score) (performance)
Main change from baseline of cornea and conjunctiva staining (Oxford score) in the worse eye and contralateral eye
Time frame: 84 days
Meibomian gland expression (performance)
Main change from baseline of meibomian gland expression score in the worse eye and contralateral eye
Time frame: 28 days
Meibomian gland expression (performance)
Main change from baseline of meibomian gland expression score in the worse eye and contralateral eye
Time frame: 84 days
Meibum quality (performance)
Main change from baseline of meibum quality score in the worse eye and contralateral eye
Time frame: 28 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Meibum quality (performance)
Main change from baseline of meibum quality score in the worse eye and contralateral eye
Time frame: 84 days
Meiboscopy (performance)
Main change from baseline of the number of partially missing or dropout meibomian glands in the worse eye and contralateral eye
Time frame: 28 days
Meiboscopy (performance)
Main change from baseline of the number of partially missing or dropout meibomian glands in the worse eye and contralateral eye
Time frame: 84 days
Eyelid margin abnormalities (performance)
Main change from baseline of the eyelid margin abnormalities score in the worse eye and contralateral eye
Time frame: 28 days
Eyelid margin abnormalities (performance)
Main change from baseline of the eyelid margin abnormalities score in the worse eye and contralateral eye
Time frame: 84 days
OSDI (questionnaire) (performance)
Main change from baseline of OSDI (Ocular Surface Disease Index) in the worse eye and contralateral eye
Time frame: 28 days
OSDI (questionnaire) (performance)
Main change from baseline of OSDI (Ocular Surface Disease Index) in the worse eye and contralateral eye
Time frame: 84 days
Global performance by the investigator (performance)
Global performance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Time frame: 28 days
Global performance by the investigator (performance)
Global performance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Time frame: 84 days
Global performance by the patient (performance)
Global performance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Time frame: 28 days
Global performance by the patient (performance)
Global performance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Time frame: 84 days
Global tolerance by the investigator (safety)
Global tolerance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Time frame: 28 days
Global tolerance by the investigator (safety)
Global tolerance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Time frame: 84 days
Global tolerance by the patient (safety)
Global tolerance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Time frame: 28 days
Global tolerance by the patient (safety)
Global tolerance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Time frame: 84 days
Intensity of ocular symptoms upon instillation (safety)
Evaluation of intensity of ocular symptoms upon instillation on a scale from 0 (none) to 3 (severe)
Time frame: 28 days
Intensity of ocular symptoms upon instillation (safety)
Evaluation of intensity of ocular symptoms upon instillation on a scale from 0 (none) to 3 (severe)
Time frame: 84 days
Duration of ocular symptoms upon instillation (safety)
Evaluation of duration of ocular symptoms upon instillation in seconds/minutes/hours
Time frame: 28 days
Duration of ocular symptoms upon instillation (safety)
Evaluation of duration of ocular symptoms upon instillation in seconds/minutes/hours
Time frame: 84 days
Frequency of ocular symptoms upon instillation (safety)
Evaluation of frequency of ocular symptoms upon instillation on a scale from 1 (rarely) to 4 (very often)
Time frame: 28 days
Frequency of ocular symptoms upon instillation (safety)
Evaluation of frequency of ocular symptoms upon instillation on a scale from 1 (rarely) to 4 (very often)
Time frame: 84 days
Number of Adverse Events
Collection of ocular and systemic adverse events
Time frame: 84 days