PMID- 33514891
OWN - NLM
STAT- MEDLINE
DCOM- 20220414
LR  - 20220417
IS  - 1476-5454 (Electronic)
IS  - 0950-222X (Print)
IS  - 0950-222X (Linking)
VI  - 35
IP  - 12
DP  - 2021 Dec
TI  - Topical lipoic acid choline ester eye drop for improvement of near visual acuity 
      in subjects with presbyopia: a safety and preliminary efficacy trial.
PG  - 3292-3301
LID - 10.1038/s41433-020-01391-z [doi]
AB  - OBJECTIVES: This study evaluated the safety of topical lipoic acid choline ester 
      (UNR844, 1.5%) ophthalmic solution and its efficacy in improving 
      distance-corrected near visual acuity (DCNVA) in subjects with presbyopia. 
      SUBJECTS AND METHODS: This was a prospective, randomized, double-masked, and 
      multicentre clinical trial. Subjects with a diagnosis of presbyopia (n = 75) were 
      randomized 2:1 to UNR844 or placebo. On days 1-7, all subjects were dosed 
      unilaterally (twice a day, b.i.d.) in their non-dominant eye to ensure safety and 
      tolerability prior to days 8-91 when dosing was changed to bilateral (b.i.d.). 
      Clinical assessments, including DCNVA and adverse events (AEs), were recorded at 
      each study visit. Patients who completed the study were recruited into a 
      non-interventional follow-up study that monitored them until 7 months after their 
      final UNR844 exposure. The primary endpoints were safety and the mean change in 
      DCNVA from baseline in the study eye. RESULTS: UNR844 administration (n = 50) 
      produced no safety concerns and was well-tolerated, with no clinically-relevant 
      changes in best-corrected distance visual acuity, pupil size, intraocular 
      pressure, or discontinuations due to adverse events. DCNVA improved in the study 
      eye in the UNR844 group compared to placebo during the 91 days of treatment 
      [UNR844 vs. placebo, mean change in LogMAR (SD); -0.159 (0.120) vs. -0.079 
      (0.116)]. Bilateral DCNVA improved, with 53.1% UNR844 vs. 21.7% placebo subjects 
      gaining >/=10 letters. Improvements in DCNVA were sustained at 5 and 7 months after 
      UNR844 dosing ceased. CONCLUSIONS: These results support further development of 
      UNR844 ophthalmic solution for the treatment of presbyopia.
CI  - (c) 2021. This is a U.S. government work and not under copyright protection in the 
      U.S.; foreign copyright protection may apply.
FAU - Korenfeld, Michael S
AU  - Korenfeld MS
AUID- ORCID: 0000-0003-1804-5525
AD  - Comprehensive Eye Care Center Ltd, 901 East Third Street, Washington, MO, 63090, 
      USA. michaelskorenfeld@gmail.com.
FAU - Robertson, Stella M
AU  - Robertson SM
AD  - Arrochar Consulting, LLC, 7045 Shadow Creek Court, Fort Worth, TX, 76132, USA.
FAU - Stein, Jerry M
AU  - Stein JM
AD  - Summer Creek Consulting, LLC, 8101 Rain Dance Trail, Fort Worth, TX, 76123, USA.
FAU - Evans, David G
AU  - Evans DG
AD  - Total Eye Care, PA, 6060 Primacy Parkway, Memphis, TN, 38119, USA.
FAU - Rauchman, Steven H
AU  - Rauchman SH
AD  - North Valley Eye Medical Group, 11550 Indian Hills Road, Mission Hill, CA, 91345, 
      USA.
FAU - Sall, Kenneth N
AU  - Sall KN
AD  - Sall Research Medical Centre, 11423 87th Street, Artesia, CA, 90701, USA.
FAU - Venkataraman, Subha
AU  - Venkataraman S
AD  - Novartis Pharmaceutical Corporation, 1 Health Plaza, East Hanover, NJ, 07936, 
      USA.
FAU - Chen, Bee-Lian
AU  - Chen BL
AD  - Novartis Pharmaceutical Corporation, 1 Health Plaza, East Hanover, NJ, 07936, 
      USA.
FAU - Wuttke, Mark
AU  - Wuttke M
AD  - Novartis Pharma AG, Basel, Switzerland.
FAU - Burns, William
AU  - Burns W
AD  - Encore Vision, Inc., 1120 South Freeway, Suite 118, Fort Worth, TX, 76104, USA.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20210129
PL  - England
TA  - Eye (Lond)
JT  - Eye (London, England)
JID - 8703986
RN  - 0 (Esters)
RN  - 0 (Ophthalmic Solutions)
RN  - 73Y7P0K73Y (Thioctic Acid)
RN  - N91BDP6H0X (Choline)
SB  - IM
MH  - Choline
MH  - Esters
MH  - Follow-Up Studies
MH  - Humans
MH  - Ophthalmic Solutions
MH  - *Presbyopia/drug therapy
MH  - Prospective Studies
MH  - *Thioctic Acid
MH  - Visual Acuity
PMC - PMC8602643
COIS- MSK: Consultant-Novartis; Financial support-Novartis and Encore Vision, Inc. SMR: 
      Consultant-Encore Vision, Inc.; Financial support - Encore Vision, Inc. and 
      Novartis. JMS: Consultant - Encore Vision, Inc. DGE: Financial support - Encore 
      Vision, Inc., Allergan and Orasys. KNS: Consultant - Kala Pharmaceuticals, 
      Novaliq, Ocular Therapeutix, Sun Pharma; Financial Support - Encore Vision, Inc., 
      Novartis and Valeant. SV, BC, and MW: - Employees of Novartis. WB: - Employee of 
      Encore Vision, Inc.
EDAT- 2021/01/31 06:00
MHDA- 2022/04/15 06:00
PMCR- 2021/01/29
CRDT- 2021/01/30 05:31
PHST- 2020/05/19 00:00 [received]
PHST- 2020/12/18 00:00 [accepted]
PHST- 2020/11/15 00:00 [revised]
PHST- 2021/01/31 06:00 [pubmed]
PHST- 2022/04/15 06:00 [medline]
PHST- 2021/01/30 05:31 [entrez]
PHST- 2021/01/29 00:00 [pmc-release]
AID - 10.1038/s41433-020-01391-z [pii]
AID - 1391 [pii]
AID - 10.1038/s41433-020-01391-z [doi]
PST - ppublish
SO  - Eye (Lond). 2021 Dec;35(12):3292-3301. doi: 10.1038/s41433-020-01391-z. Epub 2021 
      Jan 29.