PMID- 21629568
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20110616
LR  - 20220309
IS  - 1177-5483 (Electronic)
IS  - 1177-5467 (Print)
IS  - 1177-5467 (Linking)
VI  - 5
DP  - 2011
TI  - Ocular iontophoresis of EGP-437 (dexamethasone phosphate) in dry eye patients: 
      results of a randomized clinical trial.
PG  - 633-43
LID - 10.2147/OPTH.S19349 [doi]
AB  - PURPOSE: To assess safety and efficacy of EGP-437 (dexamethasone phosphate 40 
      mg/mL [DP]) in dry eye patients. METHODS: The study employed a prospective, 
      single-center, double-masked design utilizing a Controlled Adverse Environment 
      (CAE). Patients (n = 103) with confirmed signs and symptoms of dry eye syndrome 
      were randomized into 1 of 3 iontophoresis treatment groups: 7.5 mA-min at 2.5 mA 
      (DP 7.5, n = 41); 10.5 mA-min at 3.5 mA (DP 10.5, n = 37); or 10.5 mA-min at 3.5 
      mA (placebo, n = 25). Three CAE visits and 4 follow-up visits occurred over 3 
      weeks. Patients meeting enrollment criteria received iontophoresis in both eyes 
      after the second CAE exposure (visit 3) and before the third CAE exposure (visit 
      5). Primary efficacy endpoints were corneal staining and ocular discomfort. 
      Secondary endpoints included tear film break-up time, ocular protection index 
      (OPI), and symptomatology. RESULTS: The DP 7.5 and DP 10.5 treatment groups 
      showed statistically significant improvements in signs and symptoms of dry eye at 
      various time points; however, the primary endpoints were not achieved. The DP 7.5 
      treatment group exhibited statistically significant improvements in corneal 
      staining (when comparing the differences between study entry and exit, 3 weeks, P 
      = 0.039), OPI (immediately following the second treatment, P = 0.048) and ocular 
      discomfort at follow-up visits (a week after the first treatment, P = 0.032; 24 
      hours after the second treatment, P = 0.0032). Treatment-emergent adverse events 
      (AEs) were experienced by 87% of patients and were consistent across all 
      treatment groups. Most AEs were mild and no severe AEs were observed. CONCLUSION: 
      Ocular iontophoresis of EGP-437 demonstrated statistically and clinically 
      significant improvements in signs and symptoms of dry eye syndrome within a CAE 
      model.
FAU - Patane, Michael A
AU  - Patane MA
AD  - Eyegate Pharmaceuticals, Inc, 100 Beaver Street, Waltham, MA 02453, USA. 
      mpatane@eyegatepharma.com
FAU - Cohen, Amy
AU  - Cohen A
FAU - From, Stephen
AU  - From S
FAU - Torkildsen, Gail
AU  - Torkildsen G
FAU - Welch, Donna
AU  - Welch D
FAU - Ousler, George W 3rd
AU  - Ousler GW 3rd
LA  - eng
PT  - Journal Article
DEP - 20110515
PL  - New Zealand
TA  - Clin Ophthalmol
JT  - Clinical ophthalmology (Auckland, N.Z.)
JID - 101321512
PMC - PMC3104791
OTO - NOTNLM
OT  - Controlled Adverse Environment (CAE)
OT  - dry eye
OT  - iontophoresis
OT  - ocular protection index (OPI)
EDAT- 2011/06/02 06:00
MHDA- 2011/06/02 06:01
PMCR- 2011/05/15
CRDT- 2011/06/02 06:00
PHST- 2011/05/13 00:00 [received]
PHST- 2011/06/02 06:00 [entrez]
PHST- 2011/06/02 06:00 [pubmed]
PHST- 2011/06/02 06:01 [medline]
PHST- 2011/05/15 00:00 [pmc-release]
AID - opth-5-633 [pii]
AID - 10.2147/OPTH.S19349 [doi]
PST - ppublish
SO  - Clin Ophthalmol. 2011;5:633-43. doi: 10.2147/OPTH.S19349. Epub 2011 May 15.