PMID- 29928109
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220318
IS  - 1177-5467 (Print)
IS  - 1177-5483 (Electronic)
IS  - 1177-5467 (Linking)
VI  - 12
DP  - 2018
TI  - Comparative study of 0.1% hyaluronic acid versus 0.5% carboxymethylcellulose in 
      patients with dry eye associated with moderate keratitis or keratoconjunctivitis.
PG  - 1081-1088
LID - 10.2147/OPTH.S161578 [doi]
AB  - BACKGROUND: Eye drops containing 0.1% hyaluronic acid (HA) and 0.5% 
      carboxymethylcellulose (CMC) applied one drop three times a day per affected eye 
      were compared in patients with moderate keratitis or keratoconjunctivitis related 
      to dry eye disease (DED). PATIENTS AND METHODS: This was a prospective, 
      randomized, multicenter, Phase IIIB noninferiority study, with a single-masked 
      phase in parallel mode with two groups over 84 days. The primary efficacy outcome 
      was change in ocular surface (OS) staining between day 0 (D0) and day 35 (D35). 
      The conjunctiva and cornea were stained with lissamine green and fluorescein. 
      Secondary efficacy measures at day 84 (D84) were OS-staining score (SS), ocular 
      comfort index, tear-film breakup time and how patients and investigators rated 
      treatment efficacy and safety. RESULTS: At D35, 0.1% HA achieved a 46.6% 
      reduction in OS-SS (-2.03+/-1.35 points, n=39 patients) and 0.5% CMC treatment, 
      followed by a 34.9% reduction (-1.61+/-1.69 points, n=38 patients) compared to D0. 
      At D84, the SS difference to D0 improved by -2.58+/-1.45 points (-59.2%) for 0.1% 
      HA and -2.59+/-2.27 points (-54.4%) for 0.5% CMC. Ocular comfort-index scores 
      improved, with significantly lower (better) values for stinging and itching on 
      D84 for 0.1% HA. Patients assessed treatment with 0.1% HA as significantly better 
      than 0.5% CMC (Likert scale, 4.82 vs 3.97; P=0.018). Four adverse events (AEs) 
      occurred in four of 41 patients (9.8%) treated with 0.1% HA, and three AEs in two 
      of 39 patients (5.1%) treated with 0.5% CMC. No serious AEs were noted. 
      CONCLUSION: DED signs and symptoms of DED significantly improved with both eye 
      drops. OS staining improved >54% at D84. Treatment was well tolerated, with only 
      minor AEs <10%. 0.1% HA and 0.5% CMC were equally safe and effective. Significant 
      and nonsignificant results were constantly in favor of 0.1% HA.
FAU - Gross, Dorothea
AU  - Gross D
AD  - Ursapharm Arzneimittel GmbH, Saarbrucken, Germany.
FAU - Childs, Marc
AU  - Childs M
AD  - Laboratoires Delbert, Paris.
FAU - Piaton, Jean-Marie
AU  - Piaton JM
AD  - Ophthalmologic Practice, Domont, France.
LA  - eng
PT  - Journal Article
DEP - 20180611
PL  - New Zealand
TA  - Clin Ophthalmol
JT  - Clinical ophthalmology (Auckland, N.Z.)
JID - 101321512
PMC - PMC6001744
OTO - NOTNLM
OT  - carboxymethylcellulose
OT  - eye drops
OT  - fluorescein
OT  - hyaluronate
OT  - lissamine green
COIS- Disclosure DG is an employee of Ursapharm. MC is the CEO of Laboratoires Delbert. 
      He was appointed as CRO for this clinical study by Ursapharm. JMP reports no 
      conflicts of interest in this work.
EDAT- 2018/06/22 06:00
MHDA- 2018/06/22 06:01
PMCR- 2018/06/11
CRDT- 2018/06/22 06:00
PHST- 2018/06/22 06:00 [entrez]
PHST- 2018/06/22 06:00 [pubmed]
PHST- 2018/06/22 06:01 [medline]
PHST- 2018/06/11 00:00 [pmc-release]
AID - opth-12-1081 [pii]
AID - 10.2147/OPTH.S161578 [doi]
PST - epublish
SO  - Clin Ophthalmol. 2018 Jun 11;12:1081-1088. doi: 10.2147/OPTH.S161578. eCollection 
      2018.