PurposeThe purpose of this study was to evaluate the aqueous humor bioavailability and clinical efficacy of bromfenac 0.09% vs nepafenac on the presence of cystoid macular edema (CME) after phacoemulsification.Material and methodsA Phase II, double-blind, masked, active-controlled, multicenter, clinical trial of 139 subjects, randomized to either a bromfenac 0.09% ophthalmic solution (n=69) or nepafenac 0.1% (n=70). Subjects instilled a drop three times a day for a period of 30 days. Follow-up visits were on days 2, 7, 15, 30, and 60. Biomicroscopy, clinical ocular signs, and assessment of posterior segment were performed. The primary efficacy endpoints included the presence of CME evaluated by optical coherence tomography. Safety evaluation included intraocular pressure, transaminase enzymes, lissamine green, and fluorescein stain.ResultsThe demographic and efficacy variables were similar between groups at baseline. The presence of pain, photophobia, conjunctival hyperemia, chemosis, cellularity, and corneal edema disappeared by day 30 in both groups. The central retinal thickness did not show significant changes after treatment when compared to baseline as follows: in the bromfenac group (247.2±32.9 vs 252.0±24.9 μm; P=0.958) and in nepafenac group (250.8±34 vs 264.0±34.1 μm; P=0.137), respectively. A statistically significant difference was observed between bromfenac and nepafenac group: (252.0±24.9 vs 264.0±34.1 μm; P=0.022), at day 30, respectively; even though there was no clinical relevance in the presentation of CME. There were no significant alterations in intraocular pressure, either lissamine green or fluorescein stains. The adverse events were not related to the interventions.ConclusionBromfenac 0.09% ophthalmic solution showed similar clinical efficacy to reduce the presentation of CME after phacoemulsification compared to nepafenac 0.01%.

Background: The purpose of this study was to compare the efficacy and safety of difluprednate 0.05% (PRO-145) versus prednisolone acetate 1% (Prednefrin ® SF), for management of postoperative inflammation and pain, after cataract surgery. Methods: This was a Phase III, multicenter, prospective, double-blind, clinical trial. Intentto-treat population included 178 post-phacoemulsification patients that were assigned to receive either PRO-145, or prednisolone. One day after unilateral eye surgery, patients instilled a drop 4 times a day for 14 days (then tapering the dose downward for 14 days). The primary efficacy endpoints were anterior chamber (AC) cell grade and flare. Other parameters measured included: retinal central thickness (measured via OCT), conjunctival hyperemia, edema, pain and photophobia. Tolerability and safety were assessed through burning, itching, foreign body sensation, visual acuity (VA), intraocular pressure (IOP) and incidence of adverse events (AE). Results: A total of 171 subjects were randomized (1:1) and completed the study. Compared to day 1, there was a significant improvement in the AC cell count and flare in both groups by the final visit (80.2% vs 88.4%, p=1.000). Conjunctival hyperemia improved in a similar fashion (81.2% vs 79%, p=0.234) in both PRO-145 and prednisolone groups, without differences between them. This was also observed for edema (82.4% vs 82.5%, p=0.246), pain (15.3% vs 7%, p=0.497) and photophobia (16.4% vs 15.1%, p=0.246), respectively. There was no significant difference between treatments for any tolerability parameter studied. Finally, at the 4-week postoperative visit, there were no significant differences between treatments for VA, IOP and AE results (p-values; 0.095, 0.053 and 0.099, respectively). Conclusion: The results of this study suggest that PRO-145 is as effective and safe as prednisolone acetate in treating postoperative inflammation and pain in patients undergoing phacoemulsification. The study was registered at ClinicalTrials.gov as NCT03693989.

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.

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Objetivo: Analizar indicadores de calidad de vida en pacientes con catarata senil tratados con facoemulsificación más implante de lente intraocular. Método: Pacientes a partir de 60 años de edad, con agudeza visual mejor corregida (AVMC) ≥ 0.6 LogMAR y catarata senil tratada con facoemulsificación más implante de lente intraocular para casos y catarata senil incipiente sin tratamiento quirúrgico con AVMC < 0.6 LogMAR para controles. Criterios de exclusión: patologías que modificaran la calidad de vida. Se aplicó la encuesta WHOQOL-OLD en el preoperatorio y a 1 y 3 meses posquirúrgicos. Resultados: 54 controles y 56 casos. La AVMC preoperatoria fue 1.57 ± 1.041, y al tercer mes 0.68 ± 0.7817 (p < 0.001). Los resultados de la encuesta preoperatoria en comparación con el tercer mes fueron: dominio de intimidad 12.96 vs. 11.06 (p < 0.0001); dominio de muerte y agonía 10.48 vs. 6.389 (p <0.00001); dominio de participación social 12.07 vs. 13.76 (p < 0.0007); y dominio de capacidad sensorial 13.02 vs. 8.648 (p < 0.0001). Los resultados de la encuesta del tercer mes en comparación con los controles fueron: dominio de intimidad 9.66 vs. 11.06 (p < 0.001); dominio de actividades pasadas, presentes y futuras 13.89 vs. 12.39 (p < 0.001) y dominio de autonomía 12.47 vs. 10.15 (p < 0.001). Conclusión: Los pacientes presentan una mejora en la AVMC y en los resultados de la WHOQOL-OLD, por lo que deben ser tomados en cuenta para apoyar la indicación quirúrgica.