Clinical and Biological Evaluation of NAAGA Versus Azelastine Eye Drops in Allergic Subjects With Tear Film Dysfunction

PHASE4CompletedINTERVENTIONAL
Enrollment

134

Participants

Timeline

Start Date

April 21, 2023

Primary Completion Date

March 28, 2024

Study Completion Date

March 28, 2024

Conditions
Allergic ConjunctivitisDry Eye Disease (DED)
Interventions
DRUG

NAAGA (N-acetyl-aspartyl-glutamate) 49 mg/mL

80 patients were randomly assigned to NAAGA in single dose (49 mg/mL), instilled as 1 drop per eye four times daily for four weeks. Specific diagnostic tests and procedures for dry eye disease were performed at week 0 (baseline), week 2 and week 4.

DRUG

azelastine hydrochloride 0.05%

54 patients were randomly assigned to azelastine hydrochloride 0.05% instilled as 1 drop per eye 2 times a day in the conjunctival sac for for four weeks. Specific diagnostic tests and procedures for dry eye disease were performed at week 0 (baseline), week 2 and week 4.

Trial Locations (1)

84131

Azienda Ospedaliera Universitaria OO.RR. S. Giovanni di Dio e Ruggi D'Aragona, Salerno

All Listed Sponsors
lead

Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

OTHER