Evidence map›Paper›PMID 36246939›Full record

ArticleOphthalmology science2021

Combinations of Pilocarpine and Oxymetazoline for the Pharmacological Treatment of Presbyopia: Two Randomized Phase 2 Studies.

Francis W Price, Milton Hom, Majid Moshirfar, David Evans, Haixia Liu, Jeff Penzner, Michael R Robinson, Sungwook Lee, David L Wirta

Open access · goldAbstract read
In one paragraph

Article in Ophthalmology science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
3.4field-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

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Pooled it
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  6. Review
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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

9 authors at 5 institutions in 1 country.

Francis W PricePrice Vision Group, Indianapolis, Indiana.
Milton HomCanyon City Eyecare, Azusa, California.
Majid MoshirfarHoopes Vision, Draper, Utah.
David EvansTotal Eye Care, Memphis, Tennessee.
Haixia LiuAllergan, an Abbvie Company, Irvine, California.
Jeff PenznerAllergan, an Abbvie Company, Irvine, California.
Michael R RobinsonAllergan, an Abbvie Company, Irvine, California.
Sungwook LeeAllergan, an Abbvie Company, Irvine, California.
David L WirtaEye Research Foundation, Newport Beach, California.
AbbVie (United States) · USEye Care Associates · USPrice Vision Group · USSmith-Kettlewell Eye Research Institute · USUniversity of Utah · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: To determine the safety, efficacy, and tolerability of combinations of pilocarpine (Pilo) and oxymetazoline (Oxy) ocular drops dosed once daily and identify the optimal concentration of each for the pharmacologic treatment of presbyopia. Design: Two concurrent Phase 2, multicenter, double-masked, randomized, vehicle-controlled studies, 1 short-term and 1 extended study. Participants: Emmetropic individuals affected by presbyopia and in good general health. Methods: Uncorrected near visual acuity (UNVA) was measured throughout both studies with various concentrations and combinations of Pilo (0%, 0.5% 1.0%, and 1.5%) and Oxy (0%, 0.0125%, 0.05%, and 0.125%). For safety, uncorrected distance visual acuity (UDVA) was measured, treatment-emergent adverse events (TEAEs) were recorded, and a temporal/supraorbital headache assessment was completed. Main Outcome Measures: The primary efficacy end point was mean change from baseline in UNVA. Results: In the short-term study, Pilo was shown to produce a significant dose response in the average increase of letters ( Conclusions: On the basis of the results of the 2 Phase 2 studies, AGN-190584, a reading drop containing an optimized concentration of pilocarpine HCl (1.25%) delivered using a proprietary formulation, was developed and is currently under investigation in Phase 3 studies.

Indexed as

AccommodationAE, adverse eventANCOVA, analysis of covarianceD, dioptersDE, dominant eyeIxRS, interactive response systemmITT, modified intent-to-treatNDE, nondominant eyeOxymetazolineOxy, oxymetazolinePharmacological TreatmentPilocarpinePilo, pilocarpinePinholePresbyopiaSD, standard deviationTEAE, treatment-emergent adverse eventUDVA, uncorrected distance visual acuityUncorrected near visual acuityUNVA, uncorrected near visual acuityVAS, visual analog scale

Identifiers

PMID36246939
PMCPMC9562347
OpenAlexW3203550635

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.