PMID- 31118556
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201001
IS  - 1177-5467 (Print)
IS  - 1177-5483 (Electronic)
IS  - 1177-5467 (Linking)
VI  - 13
DP  - 2019
TI  - 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.
PG  - 781-787
LID - 10.2147/OPTH.S203648 [doi]
AB  - 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.
FAU - Chavez-Mondragon, Eduardo
AU  - Chavez-Mondragon E
AUID- ORCID: 0000-0002-3665-0254
AD  - Fundacion de Asistencia Privada Conde de Valenciana, IAP, CDMX, Mexico.
FAU - Palacio, Claudia
AU  - Palacio C
AD  - Fundacion Hospital Nuestra Senora de la Luz, IAP, CDMX, Mexico.
FAU - Soto-Gomez, Abraham
AU  - Soto-Gomez A
AUID- ORCID: 0000-0003-3588-1322
AD  - Catarata y Glaucoma de Occidente, SA de CV, Guadalajara, Jalisco, Mexico.
FAU - Villanueva-Najera, Miguel
AU  - Villanueva-Najera M
AUID- ORCID: 0000-0001-6324-4748
AD  - Private Office, CDMX, Mexico.
FAU - De Wit-Carter, Guillermo
AU  - De Wit-Carter G
AD  - Asociacion para Evitar la Ceguera en Mexico IAP, CDMX, Mexico.
FAU - Suarez-Velasco, Ruben
AU  - Suarez-Velasco R
AD  - Novam y Vita, Guadalajara, Jalisco, Mexico.
FAU - Baiza-Duran, Leopoldo
AU  - Baiza-Duran L
AD  - Clinical Research Department, Laboratorios Sophia, SA de CV, Zapopan, Jalisco, 
      Mexico.
FAU - Olvera-Montano, Oscar
AU  - Olvera-Montano O
AUID- ORCID: 0000-0003-2717-349X
AD  - Clinical Research Department, Laboratorios Sophia, SA de CV, Zapopan, Jalisco, 
      Mexico.
FAU - Munoz-Villegas, Patricia
AU  - Munoz-Villegas P
AUID- ORCID: 0000-0002-7559-1218
AD  - Clinical Research Department, Laboratorios Sophia, SA de CV, Zapopan, Jalisco, 
      Mexico.
LA  - eng
PT  - Journal Article
DEP - 20190502
PL  - New Zealand
TA  - Clin Ophthalmol
JT  - Clinical ophthalmology (Auckland, N.Z.)
JID - 101321512
PMC - PMC6507105
OTO - NOTNLM
OT  - Ocular Surface Disease Index
OT  - conjunctival hyperemia
OT  - nonsteroidal anti-inflammatory drug
OT  - ocular lubricant
COIS- This study was sponsored by Laboratorios Sophia, SA de CV. Leopoldo Baiza-Duran, 
      Oscar Olvera-Montano, and Patricia Munoz-Villegas are employees of Laboratorios 
      Sophia. The authors declare that they have no other competing interests in this 
      work.
EDAT- 2019/05/24 06:00
MHDA- 2019/05/24 06:01
PMCR- 2019/05/02
CRDT- 2019/05/24 06:00
PHST- 2019/01/31 00:00 [received]
PHST- 2019/03/27 00:00 [accepted]
PHST- 2019/05/24 06:00 [entrez]
PHST- 2019/05/24 06:00 [pubmed]
PHST- 2019/05/24 06:01 [medline]
PHST- 2019/05/02 00:00 [pmc-release]
AID - 203648 [pii]
AID - 10.2147/OPTH.S203648 [doi]
PST - epublish
SO  - Clin Ophthalmol. 2019 May 2;13:781-787. doi: 10.2147/OPTH.S203648. eCollection 
      2019.