Efficacy and safety of bromfenac 0.09% and sodium hyaluronate 0.4% combination therapy, versus placebo in patients with pterygium I-III for clinical signs on ocular inflammation.

ABSTRACT: Purpose: This study evaluated the clinical efficacy and safety of bromfenac 0.09%, sodium hyaluronate 0.4% (SH) combination therapy, versus placebo and SH in a clinical model of pterygium I-III. Methods: A total of 166 eyes (99 patients) with pterygium grade I-III were randomized to bromfenac 0.09% ophthalmic solution+SH 0.4% or placebo+SH 0.4%. This was a Phase IV, prospective, parallel, double-masked, multicenter clinical trial. One drop of bromfenac or placebo was instilled two times a day (BID) for 20 days, both groups accompanied treatments with one drop of SH three times a day (TID). The primary efficacy endpoints were the conjunctival hyperemia and the Ocular Surface Disease Index (OSDI) score. Other results measured included burning, foreign body sensation, and photophobia. The saf

SUBMITTER: Chavez-Mondragon E 

PROVIDER: S-EPMC6507105 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature