Viscous carbomer eye drops in patients with dry eyes. Efficacy and safety. A randomized, open, cross-over, multicentre study.
The efficacy and safety of a new carbomer containing ocular gel was compared to a commonly used 1.4% polyvinyl alcohol-based (PVA) offificial tear preparation. Sixty-one patients with symptoms and signs of dry eyes were treated with each preparation separately for two weeks in a multicentre, randomized, open cross-over study. A statistically significant difference in favour of the new viscous carbomer eye drops compared to the PVA preparation was achieved in reducing the symptom of 'dryness', the total symptom score and in prolonging the break-up time. During the carbomer eye drops period the mean daily frequency of application was 3.92 compared to 4.64 for the PVA eye drops period (p = 0.02). Twenty-three patients (38%) reported adverse events only while using the carbomer gel and 5 (8%) only while using the PVA eye drops (p < 0.001). 'Blurred vision' was the most common adverse event reported. The present carbomer containing ocular gel may offer advantages in the treatment of dry eyes.
Marner
K
K
Vester Voldgade, Copenhangen, Denmark.
Møoller
P M
PM
Dillon
M
M
Rask-Pedersen
E
E
D000179:Acrylates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018592:Cross-Over Studies; D004337:Drug Carriers; D015352:Dry Eye Syndromes / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011108:Polymers / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011142:Polyvinyl Alcohol; D012449:Safety; D013395:Sucrose / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
D000179:Acrylates; D004337:Drug Carriers; C094190:Lubrithal; D009883:Ophthalmic Solutions; D011108:Polymers; D013395:Sucrose; D011142:Polyvinyl Alcohol