Evidence map›Paper›PMID 30908338›Full record

Trial reportCornea2019

Management of Ocular Allergy Itch With an Antihistamine-Releasing Contact Lens.

Brian Pall, Paul Gomes, Frank Yi, Gail Torkildsen

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cornea, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
5.8field-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.

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

14 citing papers in PubMed, 55 citations in OpenAlex.

  1. Article
  2. Contemporary Research Questions in the Field of Contact Lenses and Where to Next?Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists) · 2026
    Review
  3. Review
  4. Article
  5. Review
  6. Review
  7. Article
  8. Article
  9. Therapeutic Targets in Allergic Conjunctivitis.Pharmaceuticals (Basel, Switzerland) · 2022
    Review
  10. Knowledge and awareness of ocular allergy among Jeddah population.Journal of family medicine and primary care · 2022
    Article
  11. Review
  12. Article
  13. Article
  14. 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

4 authors at 2 institutions in 1 country.

Brian PallJohnson & Johnson Vision, Jacksonville, FL.
Paul GomesOra, Inc, Andover, MA.
Frank YiJohnson & Johnson Vision, Jacksonville, FL.
Gail TorkildsenAndover Eye Associates, Andover, MA.
Andover Eye Associates · USJohnson & Johnson (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeA contact lens (CL)-based drug delivery system for therapeutic delivery of the antihistamine ketotifen was tested in 2 parallel, conjunctival allergen challenge-based trials.

methodsBoth trials employed the same multicenter, randomized, placebo-controlled protocol. Test lenses were etafilcon A with 0.019 mg ketotifen; control lenses were etafilcon A with no added drug. Subjects were randomized into 3 treatment groups. Group 1 received test lens in one eye and control lens in the contralateral eye; the eye chosen to receive test lens was randomly selected in a 1:1 ratio. Group 2 received test lenses bilaterally, and group 3 received control lenses bilaterally. Allergen challenges were conducted on 2 separate visits: following lens insertion, the subjects were challenged at 15 minutes (to test onset) and 12 hours (to test duration). The primary endpoint was ocular itching measured using a 0 to 4 scale with half-unit steps. Secondary endpoints included ciliary, conjunctival, and episcleral hyperemia.

resultsThe mean itching scores were lower for eyes wearing the test lens as compared to those that received control lenses, indicating that the test lens effectively reduced allergic responses. Mean differences in itching were statistically and clinically significant (mean score difference ≥ 1) at both onset and duration for both trials.

conclusionsThis large-scale assessment (n = 244) is the first demonstration of efficacy for CL delivery of a therapeutic for ocular allergy. Results are comparable to direct topical drug delivery and suggest that the lens/ketotifen combination can provide a means of simultaneous vision correction and treatment for CL wearers with ocular allergies.

Indexed as

Contact LensesAdolescentAdultAnti-Allergic AgentsChildConjunctivitis, AllergicDrug Delivery SystemsFemaleHistamine H1 AntagonistsHumansKetotifenMaleMiddle AgedYoung AdultAnti-Allergic AgentsHistamine H1 AntagonistsKetotifen

Identifiers

PMID30908338
PMCPMC6511424
OpenAlexW2925635567

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.