PMID- 31447544
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220409
IS  - 1177-5467 (Print)
IS  - 1177-5483 (Electronic)
IS  - 1177-5467 (Linking)
VI  - 13
DP  - 2019
TI  - Loteprednol etabonate (submicron) ophthalmic gel 0.38% dosed three times daily 
      following cataract surgery: integrated analysis of two Phase III clinical 
      studies.
PG  - 1427-1438
LID - 10.2147/OPTH.S210597 [doi]
AB  - PURPOSE: To evaluate the efficacy and safety of a submicron formulation of 
      loteprednol etabonate (LE) gel 0.38% instilled three times daily (TID) compared 
      with vehicle for the treatment of inflammation and pain following cataract 
      surgery with intraocular lens implantation, integrated across two multicenter, 
      double-masked, randomized, parallel-group, Phase III studies. PATIENTS AND 
      METHODS: Subjects >/=18 years of age with anterior chamber (AC) cells >/=grade 2 
      (6-15 cells) on day 1 after cataract surgery were randomized to receive 1 drop of 
      LE gel 0.38% TID, twice daily (not reported/analyzed herein), or vehicle 
      instilled in the study eye for 14 days. Primary endpoints were the proportion of 
      subjects with resolution of AC cells and grade 0 (no) pain at postoperative day 
      8. Safety outcomes included adverse events (AEs), ocular signs, fundoscopy 
      results, visual acuity, intraocular pressure (IOP), and tolerability (drop 
      comfort and ocular symptoms). RESULTS: The integrated intent-to-treat population 
      included 742 subjects (LE gel 0.38% TID, n=371; vehicle, n=371). Significantly 
      more subjects in the LE gel 0.38% TID group compared with the vehicle group had 
      complete resolution of AC cells (29.6% vs 15.1%) and grade 0 pain (74.4% vs 
      48.8%) at day 8 (P<0.0001 for both). LE gel 0.38% TID was safe and well 
      tolerated, with only 1 LE-treated subject experiencing an IOP elevation >/=10 mm 
      Hg. Most treatment-related AEs were mild and occurred less frequently with LE gel 
      0.38% than with vehicle. The majority (>75%) of subjects in each treatment group 
      reported no drop discomfort. There were no reports of blurred vision with LE gel. 
      CONCLUSION: The results of this integrated analysis indicate that LE (submicron) 
      gel 0.38% administered TID is safe and effective for the treatment of ocular 
      inflammation and pain following cataract surgery, with minimal risk of IOP 
      elevation.
FAU - Fong, Raymond
AU  - Fong R
AD  - Manhattan Eye, Ear and Throat Hospital and Lenox Hill Hospital, New York, NY, 
      USA.
FAU - Cavet, Megan E
AU  - Cavet ME
AD  - Medical Affairs, Bausch + Lomb, Rochester, NY, USA.
FAU - DeCory, Heleen H
AU  - DeCory HH
AD  - Medical Affairs, Bausch + Lomb, Rochester, NY, USA.
FAU - Vittitow, Jason L
AU  - Vittitow JL
AD  - Clinical Affairs, Bausch + Lomb, Bridgewater, NJ, USA.
LA  - eng
PT  - Journal Article
DEP - 20190801
PL  - New Zealand
TA  - Clin Ophthalmol
JT  - Clinical ophthalmology (Auckland, N.Z.)
JID - 101321512
PMC - PMC6683659
OTO - NOTNLM
OT  - cataract surgery
OT  - integrated analysis
OT  - loteprednol etabonate
OT  - postoperative inflammation
OT  - postoperative pain
OT  - submicron
COIS- MEC, HHD, and JLV are employees of Bausch Health US, LLC. The authors report no 
      other conflicts of interest in this work.
EDAT- 2019/08/27 06:00
MHDA- 2019/08/27 06:01
PMCR- 2019/08/01
CRDT- 2019/08/27 06:00
PHST- 2019/03/30 00:00 [received]
PHST- 2019/07/02 00:00 [accepted]
PHST- 2019/08/27 06:00 [entrez]
PHST- 2019/08/27 06:00 [pubmed]
PHST- 2019/08/27 06:01 [medline]
PHST- 2019/08/01 00:00 [pmc-release]
AID - 210597 [pii]
AID - 10.2147/OPTH.S210597 [doi]
PST - epublish
SO  - Clin Ophthalmol. 2019 Aug 1;13:1427-1438. doi: 10.2147/OPTH.S210597. eCollection 
      2019.