PMID- 27157843
OWN - NLM
STAT- MEDLINE
DCOM- 20170630
LR  - 20220316
IS  - 1549-4713 (Electronic)
IS  - 0161-6420 (Linking)
VI  - 123
IP  - 8
DP  - 2016 Aug
TI  - Six-Month Intraocular Pressure Reduction with a Topical Bimatoprost Ocular 
      Insert: Results of a Phase II Randomized Controlled Study.
PG  - 1685-1694
LID - S0161-6420(16)30203-2 [pii]
LID - 10.1016/j.ophtha.2016.04.026 [doi]
AB  - PURPOSE: Improving adherence to manage elevated intraocular pressure (IOP) 
      remains an unmet need. A topical bimatoprost ocular insert was compared with 
      twice-daily timolol eye drops in patients with open-angle glaucoma (OAG) or 
      ocular hypertension (OHT) treated for 6 months. DESIGN: Parallel-arm, 
      multicenter, double-masked, randomized, controlled trial. PARTICIPANTS: One 
      hundred thirty adult OAG or OHT patients. METHODS: Eligible patients were 
      randomized 1:1 to receive a bimatoprost insert plus artificial tears twice daily 
      or a placebo insert plus timolol (0.5% solution) twice daily for 6 months after a 
      screening washout period. Diurnal IOP measurements (at 0, 2, and 8 hours) were 
      obtained at baseline; weeks 2, 6, and 12; and months 4, 5, and 6. Key eligibility 
      included washout IOP of 23 mmHg or more at time 0, IOP of 20 mmHg or more at 2 
      and 8 hours, and IOP of 34 mmHg or less at all time points; no prior incisional 
      surgery for OAG or OHT; and no known nonresponders to prostaglandins. MAIN 
      OUTCOME MEASURES: The primary efficacy end point examined the difference in mean 
      change from baseline in diurnal IOPs (point estimate, 95% confidence interval) 
      across 9 coprimary end points at weeks 2, 6, and 12 comparing the bimatoprost arm 
      with the timolol arm using a noninferiority margin of 1.5 mmHg. Secondary end 
      points were diurnal IOP measurements at months 4, 5, and 6 and adverse events 
      (AEs). RESULTS: A mean reduction from baseline IOP of -3.2 to -6.4 mmHg was 
      observed for the bimatoprost group compared with -4.2 to -6.4 mmHg for the 
      timolol group over 6 months. The study met the noninferiority definition at 2 of 
      9 time points but was underpowered for the observed treatment effect. Adverse 
      events were consistent with bimatoprost or timolol exposure; no unexpected ocular 
      AEs were observed. Primary retention rate of the insert was 88.5% of patients at 
      6 months. CONCLUSIONS: Clinically relevant reduction in mean IOP was observed 
      over 6 months with a bimatoprost ocular insert and seems to be safe and well 
      tolerated. The topically applied bimatoprost insert may provide an alternative to 
      daily eye drops to improve adherence, consistency of delivery, and reduction of 
      elevated IOP.
CI  - Copyright (c) 2016 American Academy of Ophthalmology. Published by Elsevier Inc. 
      All rights reserved.
FAU - Brandt, James D
AU  - Brandt JD
AD  - Department of Ophthalmology & Vision Science, University of California, Davis, 
      Sacramento, California. Electronic address: jdbrandt@ucdavis.edu.
FAU - Sall, Kenneth
AU  - Sall K
AD  - Sall Research Medical Center, Artesia, California.
FAU - DuBiner, Harvey
AU  - DuBiner H
AD  - Clayton Eye Center, Morrow, Georgia.
FAU - Benza, Robert
AU  - Benza R
AD  - Apex Eye, Cincinnati, Ohio.
FAU - Alster, Yair
AU  - Alster Y
AD  - ForSight VISION5, Inc., Menlo Park, California.
FAU - Walker, Gary
AU  - Walker G
AD  - ForSight VISION5, Inc., Menlo Park, California.
FAU - Semba, Charles P
AU  - Semba CP
AD  - ForSight VISION5, Inc., Menlo Park, California.
CN  - Collaborators
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20160505
PL  - United States
TA  - Ophthalmology
JT  - Ophthalmology
JID - 7802443
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Delayed-Action Preparations)
RN  - 817W3C6175 (Timolol)
RN  - QXS94885MZ (Bimatoprost)
SB  - IM
MH  - Administration, Topical
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antihypertensive Agents/adverse effects/*therapeutic use
MH  - Bimatoprost/adverse effects/*therapeutic use
MH  - Delayed-Action Preparations
MH  - Double-Blind Method
MH  - Female
MH  - Follow-Up Studies
MH  - Glaucoma, Open-Angle/*drug therapy/physiopathology
MH  - Humans
MH  - Intraocular Pressure/*drug effects/physiology
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Timolol/adverse effects/therapeutic use
MH  - Tonometry, Ocular
FIR - Budenz, Donald
IR  - Budenz D
FIR - Day, Douglas
IR  - Day D
FIR - Flowers, Brian
IR  - Flowers B
FIR - Lee, Steven
IR  - Lee S
FIR - Nguyen, Quang
IR  - Nguyen Q
FIR - Wirta, David
IR  - Wirta D
EDAT- 2016/05/10 06:00
MHDA- 2017/07/01 06:00
CRDT- 2016/05/10 06:00
PHST- 2015/12/22 00:00 [received]
PHST- 2016/04/15 00:00 [revised]
PHST- 2016/04/15 00:00 [accepted]
PHST- 2016/05/10 06:00 [entrez]
PHST- 2016/05/10 06:00 [pubmed]
PHST- 2017/07/01 06:00 [medline]
AID - S0161-6420(16)30203-2 [pii]
AID - 10.1016/j.ophtha.2016.04.026 [doi]
PST - ppublish
SO  - Ophthalmology. 2016 Aug;123(8):1685-1694. doi: 10.1016/j.ophtha.2016.04.026. Epub 
      2016 May 5.