July 2019
Volume 60, Issue 9
Free
ARVO Annual Meeting Abstract  |   July 2019
Efficacy and safety of Bromfenac 0.09% ophthalmic solution in reducing clinical inflammation and symptoms relief in patients with pterygium I-III
Author Affiliations & Notes
  • Oscar Olvera Montaño
    Clinical Research Department, Laboratorios Sophia S.A. de C.V., Zapopan LSO-841221-6D2, JALISCO, Mexico
  • Leopoldo Martin Baiza-Duran
    Clinical Research Department, Laboratorios Sophia S.A. de C.V., Zapopan LSO-841221-6D2, JALISCO, Mexico
  • Patricia del Carmen Muñoz-Villegas
    Clinical Research Department, Laboratorios Sophia S.A. de C.V., Zapopan LSO-841221-6D2, JALISCO, Mexico
  • Francisco García Velez
    Clinical Research Department, Laboratorios Sophia S.A. de C.V., Zapopan LSO-841221-6D2, JALISCO, Mexico
  • Ricardo Llamas Velázquez
    Clinical Research Department, Laboratorios Sophia S.A. de C.V., Zapopan LSO-841221-6D2, JALISCO, Mexico
  • Footnotes
    Commercial Relationships   Oscar Olvera Montaño, Laboratorios Sophia, S.A. de C.V (E); Leopoldo Baiza-Duran, Laboratorios Sophia, S.A. de C.V (E); Patricia Muñoz-Villegas, Laboratorios Sophia, S.A. de C.V (E); Francisco García Velez, Laboratorios Sophia, S.A. de C.V (E); Ricardo Llamas Velázquez, Laboratorios Sophia, S.A. de C.V (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2019, Vol.60, 4725. doi:https://doi.org/
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      Oscar Olvera Montaño, Leopoldo Martin Baiza-Duran, Patricia del Carmen Muñoz-Villegas, Francisco García Velez, Ricardo Llamas Velázquez; Efficacy and safety of Bromfenac 0.09% ophthalmic solution in reducing clinical inflammation and symptoms relief in patients with pterygium I-III. Invest. Ophthalmol. Vis. Sci. 2019;60(9):4725. doi: https://doi.org/.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Medical treatment of pterygium consists of artificial tears, as well as occasional short-term use of topical corticosteroid anti-inflammatory drops when symptoms are more intense. We propose the use of a topical non-steroidal, anti-inflammatory drug (NSAID) to treat inflammation and relief of symptoms associated to pterygium.

Bromfenac is a topical NSAID, the purpose of this study was to evaluate the efficacy and safety of Bromfenac 0.09% ophthalmic solution as coadjutant to artificial tears, in the treatment of pterygium-associated inflammation and discomfort symptoms.

Methods : Eighty-three subjects diagnosed with pterygium grade I-III (Johnston Classification) were randomized (1:1) to either Bromfenac (n=41) or Placebo (n=42) arms, in this phase IV, multicenter, prospective, double-blind, clinical trial. Patients instilled a Bromfenac or Placebo drop three times a day, followed by a preservative free sodium hyaluronate ophthalmic solution drop for 20days. Follow-up visits were on days 7, 15 and 21. The efficacy endpoints were the conjunctival hyperemia, photophobia, burning, foreign body sensation and subjective symptoms were measured using the Ocular Surface Disease Index (OSDI). Safety assessments were by adverse events (AEs), intraocular pressure (IOP) and tear break-up time (TBUT).ClinicalTrials.gov NCT03521791.

Results : Demographic and baseline characteristics were similar between treatments. Compared with the baseline, there were a significant reduction in the conjunctival hyperemia: p=0.0001, McNemar test; photophobia: p=0.0001; burning: p=0.0001 and foreign body sensation: p=0.0001. Similar improvements favoring Bromfenac arm were observed in the OSDI score (12.35±16.8 vs 6.25±8.2): p=0.0001, Wilcoxon test. There were no significant alterations in intraocular pressure (p=0.068), a statistically significant difference was observed in TBUT (7.63±2.3 vs 8.29±2.23), p=0.045. A total of 16 EA were reported by 8.4% (7/83) of patients during the study, but there were no differences between treatments for their incidence (p=0.226), and weren’t treatment related.

Conclusions : The treatment with Bromfenac for three weeks reduce clinical sings and improve symptoms in patients with pterygium. These results suggest that Bromfenac 0.09% can improve safely the presentation of clinical signs on ocular inflammation.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.

 

 

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