<p>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</p>

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 safety was assessed by the tear break-up time (TBUT), visual acuity (VA), IOP, lissamine green, fluorescein stains, and the incidence of adverse events (AEs). Results: Compared with baseline, there was a significant reduction in the conjunctival hyperemia ( p =0.0001) and OSDI score in both groups ( p =0.0001). There was a significant improvement in ocular symptomatology for both, placebo/SH and bromfenac/SH groups ( p =0.0001), the decrement in the ocular burning was 41.1% vs 24.6%, the foreign body sensation was 31.5% vs 36.2% and, for photophobia was 23.3% vs 30.5%, respectively. A statistically significant difference was observed in TBUT for bromfenac/SH ( p =0.045), at day 20. There were no significant alterations in IOP ( p =0.068) or VA ( p =0.632). Similar improvements were observed in the fluorescein and green lissamine staining. Finally, the incidence of AE was similar between groups. Conclusion: The treatment with bromfenac 0.09% ophthalmic solution and SH 0.4% combination therapy for 3 weeks reduced clinical signs, in patients with pterygium I–III. The results suggest that bromfenac 0.09% can improve the symptomatology, reduce the presentation of clinical signs associated with superficial ocular inflammation.

Low-temperature plasma radiofrequency ablation and autologous conjunctival transplantation for pterygium excision.

“…UVB irradiation of human epithelial cells or broblasts isolated from normal ocular surface tissue or surgically removed pterygium specimens stimulates the expression and secretion of several proin ammatory cytokines and chemokines, such as tumor necrosis factor TNF-α, IL-1, IL-6 and MMP-9. [17][18][19][20] Upregulation of various pro-in ammatory factors plays an important role in the pathogenesis of pterygium. MMP-9 is upregulated in pterygium tissue.…”

“…Other studies have shown that MMP-1 expression is increased in pterygium, and MMP-2,3, 7, 9,14, TNF-a are also overexpressed. [17][18][19][20] Zidi S et al have found that IL-6, IL-17A and NO in tears and serum of patients with pterygium are associated with in ammatory in ltration and the expression of NOS2, NF-κB and Bcl-2 in pterygium biopsy. 21 Therefore, in ammatory markers play an important role in the development of pterygium.…”

Optimization of hyaluronan-enriched cubosomes for bromfenac delivery enhancing corneal permeation: characterization, ex vivo, and in vivo evaluation

“…Accordingly, there is an improvement in the tear film thickness and the ocular surface index as well as a reduction in the friction during blinking and ocular movements (Cagini et al., 2021 ). The treatment with bromfenac 0.09% and HA 0.4% ophthalmic solutions in a combination therapy for 3 weeks reduced the presentation of clinical signs associated with superficial ocular inflammation in patients with pterygium I–III (Chávez-Mondragón et al., 2019 ).…”