Evidence map›Paper›PMID 40216672›Full record

ArticleOphthalmology and therapy2025

Clinical Evaluation of Biotrue Hydration Plus Multipurpose Solution in Daily Use with Planned Replacement Soft Contact Lenses.

Mark Schaeffer, Ayda Shahidi, Gary Mosehauer, Marjorie Rah, William Reindel

Registry-linked trialAbstract read
In one paragraph

Article in Ophthalmology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03897751 (A Safety and Effectiveness Study of a New Contact Lens Cleaning and Disinfecting Solution), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

NCT03897751 nacompletednot on this map

A Safety and Effectiveness Study of a New Contact Lens Cleaning and Disinfecting Solution

TypeinterventionalSponsorBausch & Lomb IncorporatedRan2019 to 2019Enrolled252ConditionsContact Lens WearArmsABT12 Multi-Purpose Solution, COMPLETE Multi-Purpose Solution, Sensitive Eyes® Rewetting Drops
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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

5 authors.

Mark SchaefferMyEyeDr, Birmingham, AL, USA.
Ayda ShahidiBausch + Lomb, Rochester, NY, USA. ayda.shahidi@bausch.com.
Gary MosehauerBausch + Lomb, Rochester, NY, USA.
Marjorie RahBausch + Lomb, Rochester, NY, USA.
William ReindelBausch + Lomb, Rochester, NY, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPlanned replacement soft contact lenses (PRSCLs) continue to remain a popular option for vision correction. Biotrue Hydration Plus (BHP) is a novel multipurpose solution (MPS) developed for PRSCLs, with a formulation informed by Tear Film & Ocular Surface Society (TFOS) International Dry Eye Workshop II insights. It contains hyaluronan (HA) for moisturizing, erythritol for antioxidant and osmoprotectant properties, and potassium to support ocular homeostasis. It also incorporates poloxamine 1107 and poloxamer 181 surfactants for lens cleaning and wettability, alongside a triple disinfectant system. A two-arm study evaluated the clinical performance of BHP MPS over 3 months; here, we present a subanalysis of the BHP MPS arm.

methodsThis study was conducted across 17 sites in the USA, with evaluations at 2 weeks, 1 month, 2 months, and 3 months of lens wear. BHP MPS was dispensed to habitual wearers of silicone hydrogel or conventional hydrogel PRSCLs (four and one prespecified types, respectively). Subjects rated 13 lens performance attributes (grouped into comfort, vision, handling, lens cleanliness, and overall impression). Performance ratings were compared across visits using statistical methods to confirm consistency and equivalence. Investigators performed slit lamp examinations and evaluated lens deposits at each follow-up visit to assess MPS biocompatibility.

resultsMean scores for lens comfort, vision, handling, and cleanliness on removal, and also overall impression, were 80-100 across all visits (very good-excellent; p ≥ 0.05). No subject presented with > Grade 2 slit lamp findings at any visit, and few ungraded slit lamp findings were noted, reflecting the biocompatibility of BHP MPS with respect to the ocular surface. Lens deposition, cleanliness, and wettability were clinically acceptable in almost all subjects, and no participants discontinued owing to an adverse event.

conclusionsIn this analysis, BHP MPS was associated with minimal lens deposition, excellent biocompatibility, and high-performance ratings, making it a promising option for PRSCL wearers and for eye care practitioners to recommend before switching symptomatic wearers to a different contact lens modality.

trial registrationClinicalTrials.gov identifier NCT03897751.

Indexed as

ErythritolHomeostasisHyaluronanPoloxamerPoloxamineTFOS DEWS II

Identifiers

PMID40216672
PMCPMC12069776

What OpenQuestion holds

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Registered trials

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.