Evidence map›Paper›PMID 27257373›Full record

ArticleClinical ophthalmology (Auckland, N.Z.)2016

The IMPACT study: a prospective evaluation of the effects of cyclosporine ophthalmic emulsion 0.05% on ocular surface staining and visual performance in patients with dry eye.

Karl G Stonecipher, Gail L Torkildsen, George W Ousler, Scot Morris, Linda Villanueva, David A Hollander

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Clinical ophthalmology (Auckland, N.Z.), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
5.7field-weighted citation impact, top 4% 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.

NCT02121847 phase4completednot on this map

Investigation of Maintaining Visual Performance Achieved With Cyclosporine Therapy

TypeinterventionalSponsorAllerganRan2014 to 2014Enrolled40ConditionsDry Eye SyndromesArmscyclosporine 0.05% ophthalmic emulsion, carboxymethylcellulose-based lubricant eye drops
NCT07268599 enrolling by invitationnot on this mapstarted 2025, after this paper: background citation

Acoltremon Symptom Tracking and Relief Assessment in Moderate-to-Severe Dry Eye Disease

TypeobservationalSponsorColvard Kandavel Eye CenterRan2025 to 2026Enrolled50ConditionsDry Eye Disease (DED)ArmsAcoltremon
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 51 citations in OpenAlex.

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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

6 authors at 5 institutions in 2 countries.

Karl G StonecipherDepartment of Ophthalmology, University of North Carolina, Chapel Hill, NC, USA; TLC Laser Eye Centers, Greensboro, NC, USA.
Gail L TorkildsenAndover Eye Associates, MA, USA.
George W OuslerOra, Inc., Andover, MA, USA.
Scot MorrisEye Consultants of Colorado, Conifer, CO, USA.
Linda VillanuevaAllergan plc, Irvine, CA, USA.
David A HollanderAllergan plc, Irvine, CA, USA.
Andover Eye Associates · USAllergan (Ireland) · IEAllergan (United States) · USMinnesota Eye Consultants · USUniversity of North Carolina at Chapel Hill · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe aim of this study was to evaluate the effects of cyclosporine ophthalmic emulsion 0.05% on ocular surface staining and visual performance in patients with dry eye.

methodsThis was a single-center, 6-month, open-label, Phase IV study. Patients with bilateral dry eye disease and a symptom score of ≥2 on the Ocular Discomfort and 4-Symptom Questionnaire, an Ocular Surface Disease Index score of >12, at least one eye with Schirmer's score <10 mm/5 minutes, and central corneal staining graded as ≥2 on the Ora Calibra™ Corneal and Conjunctival Staining Scale were enrolled. Cyclosporine ophthalmic emulsion 0.05% (Restasis(®)) was instilled twice daily in each eye. The primary efficacy endpoints were ocular surface staining and visual function at 6 months. Secondary outcome measures included Schirmer's test, tear film breakup time, symptoms, and adverse events.

resultsA total of 40 patients with the mean age of 59.4 years (range, 40-78 years) were enrolled; 35 (87.5%) were female and 37 (92.5%) completed the study. At 6 months, inferior corneal, central corneal, total corneal, and total ocular surface fluorescein staining were significantly improved from baseline in both eyes (P<0.001). Patient responses on the Ocular Surface Disease Index showed significant improvement in blurred vision and visual function related to reading, driving at night, working with a computer or bank machine, and watching television (P≤0.041). At 6 months, 35.1% of patients achieved ≥5 mm improvement and 18.9% achieved ≥10 mm improvement in the average eye Schirmer score. Mean tear film breakup time improved by >50% in both eyes (P>0.001). Patients reported significant improvement in ocular discomfort and dry eye symptoms (P<0.001). No patients discontinued treatment because of stinging or any other ocular adverse event.

conclusionDry eye patients with difficulties with day-to-day visual function demonstrated improvement in both signs and symptoms of dry eye and reported improved visual function after 6 months of treatment with cyclosporine ophthalmic emulsion 0.05%.

Indexed as

clinical trialcorneal stainingdry eye diseaseOcular Surface Disease Indexocular surface stainingvisual function

Identifiers

PMID27257373
PMCPMC4874635
OpenAlexW2381631717

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.