EFFICACY AND SAFETY OF 0.3-PERCENT CARBOMER GEL COMPARED TO PLACEBO IN PATIENTS WITH MODERATE-TO-SEVERE DRY EYE SYNDROME

Purpose: Carbomer gel is a water-soluble polymeric resin that has been reported to maintain the tear film in contact with the eye for an ext ended period. The efficacy and safety of this new artificial tear were assessed. Methods: A multicenter, single-masked, randomized, placebo- controlled study was carried out on 123 patients with moderate-to-seve re dry eyes. The placebo was a mannitol solution with benzalkonium chl oride 0.008% as preservative. Patients were observed over an 8-week pe riod, and subjective and objective changes analyzed, compared to a bas eline of no therapy, after 1 to 7 days washout period from previous me dication. Results: All primary subjective symptoms decreased significa ntly in the carbomer gel-treated group compared to the placebo group ( i.e., dryness, discomfort, and foreign body sensation). The carbomer g el also significantly improved the rose bengal staining score relative to placebo. When data for the primary subjective efficacy variables w ere stratified for disease severity, there was a statistically signifi cant improvement from baseline by day 10 for severely affected patient s and from day 42 for patients with moderate disease. Secondary subjec tive symptoms that improved significantly in the tear gel group compar ed to placebo were photophobia, erythema, tear breakup time, blurry-fi lmy, dry-sandy sensation, and physician impression. However, no signif icant improvements in the secondary subjective symptoms of tearing, it ching, scaling, conjunctival discharge, palpebral conjunctival redness , bulbar conjunctival redness, conjunctival luster, relief of discomfo rt, ease of use, and overall acceptability were found in either group over the baseline scope. In addition, neither carbomer gel nor placebo improved the baseline fluorescein staining score or the Schirmer test score. Two patients suffered local allergic reactions to the carbomer gel or its preservative, which settled on withdrawal of the medicatio n. Conclusions: Carbomer gel was more efficacious than was placebo in improving a number of subjective and objective symptoms of moderate-to -severe dry eye syndrome. The results of this study indicate that carb omer gel was as safe as was the placebo.