Evidence map›Paper›PMID 27254807›Full record

Trial reportOptometry and vision science : official publication of the American Academy of Optometry2016

Dual-Polymer Drops, Contact Lens Comfort, and Lid Wiper Epitheliopathy.

Jason J Nichols, Christopher W Lievens, Marc R Bloomenstein, Haixia Liu, Peter Simmons, Joseph Vehige

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Optometry and vision science : official publication of the American Academy of Optometry, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01844388 (A Study to Compare a New Eye Drop Formulation With Refresh Contacts®), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 9% 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.

NCT01844388 phase3completednot on this map

A Study to Compare a New Eye Drop Formulation With Refresh Contacts®

TypeinterventionalSponsorAllerganRan2013 to 2013Enrolled365ConditionsContact Lens LubricationArmscarboxymethylcellulose based eye drop formula, carboxymethylcellulose sodium based eye drop solution
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

  1. Lubricating drops for contact lens discomfort in adults.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Trial
  3. Review
  4. Review
  5. A Hue-Value method for semi-automated assessment of Lid Wiper Epitheliopathy.Contact lens & anterior eye : the journal of the British Contact Lens Association · 2024
    Article
  6. Article
  7. Review
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

6 authors at 4 institutions in 3 countries.

Jason J Nichols*OD, PhD, FAAO †OD, MS, FAAO ‡OD, FAAO §PhD ∥OD School of Optometry, University of Alabama at Birmingham, Birmingham, Alabama (JJN); Southern College of Optometry, Memphis, Tennessee (CWL); Schwartz Laser Eye Center, Scottsdale, Arizona (MRB); and Allergan Clinical Research, Irvine, California (HL, PS, JV).
Christopher W Lievens
Marc R Bloomenstein
Haixia Liu
Peter Simmons
Joseph Vehige
Allergan (Ireland) · IESchwartz Laser Eye Center · USSouthern College of Optometry · USUniversity of Alabama at Birmingham · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis study compared a new contact lens rewetting drop containing both carboxymethylcellulose and hyaluronic acid (CMC-HA) with a standard drop containing carboxymethylcellulose only (CMC). Symptoms of discomfort typical in lens wear and lid wiper epitheliopathy (LWE) were assessed over a 3-month period in a diverse sample of contact lens wearers.

methodsAdapted daily-wear contact lens subjects using hydrogel, silicone hydrogel, or rigid gas permeable lenses were enrolled in this prospective, randomized, double-masked, parallel-group, 90-day study conducted at 15 clinical sites. Subjects were randomized 2:1 to CMC-HA (n = 244) or CMC alone (n = 121) with dosage at least four times per day, along with their habitual lens care system. At baseline and at days 7, 30, 60, and 90, subject-completed questionnaires, bulbar conjunctival staining, LWE, contact lens distance visual acuity (CLDVA), and standard safety measures were assessed.

resultsAt day 90, CMC-HA performed significantly better than CMC in ocular symptoms including dryness throughout the day (p = 0.006), and burning/stinging throughout the day (p = 0.02) and at the end of the day (p < 0.001). CMC-HA also performed numerically better for dryness at the end of day (p = 0.06). LWE staining was improved in the CMC-HA group at day 90 whereas it increased slightly in the CMC alone group, with a significant between-group difference (p = 0.009). CMC-HA also demonstrated greater reduction in conjunctival staining compared with CMC alone at day 90 (p = 0.08). No differences in CLDVA, contact lens wear time, acceptability, and product use were observed, and safety outcomes were similar between groups.

conclusionsThe addition of HA to a standard CMC rewetting drop improves clinical performance. In this comparison of rewetting drop efficacy in contact lens wearers, LWE was a useful clinical sign for differentiating clinical performance.

Indexed as

Patient SatisfactionAdolescentAdultAgedCarboxymethylcellulose SodiumContact LensesDouble-Blind MethodDrug CombinationsEyelid DiseasesFemaleFollow-Up StudiesHumansHyaluronic AcidMaleMiddle AgedOphthalmic SolutionsCarboxymethylcellulose SodiumDrug CombinationsHyaluronic AcidOphthalmic SolutionsPolymers

Identifiers

PMID27254807
PMCPMC4972480
OpenAlexW2410012638

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.