Evidence map›Paper›PMID 33514891›Full record

Trial reportEye (London, England)2021

Topical lipoic acid choline ester eye drop for improvement of near visual acuity in subjects with presbyopia: a safety and preliminary efficacy trial.

Michael S Korenfeld, Stella M Robertson, Jerry M Stein, David G Evans, Steven H Rauchman, Kenneth N Sall, Subha Venkataraman, Bee-Lian Chen, Mark Wuttke, William Burns

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Eye (London, England), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed
3.2field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 47 citations in OpenAlex.

  1. Trial
  2. Extract fromNutrients · 2024
    Trial
  3. Presbyopia: Current Perspectives and Prospects for Patients.Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists) · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 8 institutions in 3 countries.

Michael S KorenfeldComprehensive Eye Care Center Ltd, 901 East Third Street, Washington, MO, 63090, USA. michaelskorenfeld@gmail.com.ORCID http://orcid.org/0000-0003-1804-5525
Stella M RobertsonArrochar Consulting, LLC, 7045 Shadow Creek Court, Fort Worth, TX, 76132, USA.
Jerry M SteinSummer Creek Consulting, LLC, 8101 Rain Dance Trail, Fort Worth, TX, 76123, USA.
David G EvansTotal Eye Care, PA, 6060 Primacy Parkway, Memphis, TN, 38119, USA.
Steven H RauchmanNorth Valley Eye Medical Group, 11550 Indian Hills Road, Mission Hill, CA, 91345, USA.
Kenneth N SallSall Research Medical Centre, 11423 87th Street, Artesia, CA, 90701, USA.
Subha VenkataramanNovartis Pharmaceutical Corporation, 1 Health Plaza, East Hanover, NJ, 07936, USA.
Bee-Lian ChenNovartis Pharmaceutical Corporation, 1 Health Plaza, East Hanover, NJ, 07936, USA.
Mark WuttkeNovartis Pharma AG, Basel, Switzerland.
William BurnsEncore Vision, Inc., 1120 South Freeway, Suite 118, Fort Worth, TX, 76104, USA.
Tris Pharma (United States) · USComprehensive Eye Care · USEncore Pharmaceuticals (United States) · USNorth Valley Eye Medical Group · USNovartis (Switzerland) · CHRED Consulting (Norway) · NOSall Research Medical Center · USTotal Rehab · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThis 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

methodsThis 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.

resultsUNR844 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.

conclusionsThese results support further development of UNR844 ophthalmic solution for the treatment of presbyopia.

Indexed as

PresbyopiaThioctic AcidCholineEstersFollow-Up StudiesHumansOphthalmic SolutionsProspective StudiesVisual AcuityCholineEstersOphthalmic SolutionsThioctic Acid

Identifiers

PMID33514891
PMCPMC8602643
OpenAlexW3121264799

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.