Evidence map›Paper›PMID 35302688›Full record

Trial reportClinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology2022

Efficacy of N-acetyl aspartyl glutamic acid versus fluorometholone for treating allergic conjunctivitis in an environmental exposure chamber.

Frédéric de Blay, Alina Gherasim, Nathalie Domis, Ibrahim Choual, Tristan Bourcier

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.5field-weighted citation impact, top 11% 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

4 citing papers in PubMed, 20 citations in OpenAlex.

  1. Efficacy of N-acetyl aspartyl glutamic acid versus fluorometholone for treating allergic conjunctivitis in an environmental exposure chamber.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2022
    Trial
  2. Article
  3. Review
  4. 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 at 2 institutions in 1 country.

Frédéric de BlayALYATEC, Nouvel Hôpital Civil, 1 place de l'Hôpital, Strasbourg, France.ORCID 0000-0001-5678-2214
Alina GherasimALYATEC, Nouvel Hôpital Civil, 1 place de l'Hôpital, Strasbourg, France.
Nathalie DomisALYATEC, Nouvel Hôpital Civil, 1 place de l'Hôpital, Strasbourg, France.
Ibrahim ChoualALYATEC, Nouvel Hôpital Civil, 1 place de l'Hôpital, Strasbourg, France.
Tristan BourcierDepartment of Ophthalmology, Strasbourg University Hospital, FMTS, Strasbourg University, Strasbourg, France.
Hôpital Civil, Strasbourg · FRUniversité de Strasbourg · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTopical mast cell stabilizers were previously shown to treat the signs and symptoms of seasonal and perennial allergic conjunctivitis safely and effectively in active and placebo-controlled trials. However, mast cell stabilizers have not been compared to topical corticosteroids for efficacy. We tested the non-inferiority of a topical mast cell stabilizer, N-acetyl aspartyl glutamic acid (4.9%, NAAGA), compared to fluorometholone (0.1%, FM) during controlled exposures to the airborne birch pollen allergen, Bet v 1, in an environmental exposure chamber (EEC).

methodsThis randomized, cross-over, investigator-blinded study included 24 patients with a history of birch pollen allergic conjunctivitis. Patients were randomized to 5 days of treatment with NAAGA, then FM (n = 12) or FM, then NAAGA (n = 12). After each treatment, patients were exposed to a fixed airborne concentration of Bet v 1 in ALYATEC EEC. The primary endpoint was the amount of allergen required to trigger a conjunctival response (Abelson score ≥5). Groups were compared with a linear model for cross-over studies. Non-inferiority was assumed, when the lower bound of the risk ratio confidence interval (CI) was >0.5.

resultsAt screening, the mean time-to-conjunctival response was 72.5 ± 35.9 min. NAAGA and FM extended the response time to 114.8 ± 55.0 and 116.6 ± 51.5 min respectively. The mean amounts of allergen required to trigger a conjunctival response were 1.165 ng after NAAGA and 1.193 ng after FM treatment. The risk ratio for the conjunctival response was 0.977 (95% CI: 0.812; 1.174), which indicated non-inferiority. Adverse events occurred less frequently with NAAGA (29.2%) than with FM (58.3%).

conclusionIn patients with allergic conjunctivitis to birch pollen, NAAGA was non-inferior to FM in exposures to airborne Bet v 1. The EEC was a good model for simulating real-life airborne allergen exposure and for demonstrating the efficacy and safety of eye drops for treating allergic conjunctivitis.

trial registrationNot registered.

Indexed as

Conjunctivitis, AllergicAllergensCross-Over StudiesDipeptidesEnvironmental ExposureFluorometholoneGlutamic AcidHumansMast Cell StabilizersAllergensDipeptidesFluorometholoneGlutamic Acidisospaglumic acidMast Cell Stabilizersallergic conjunctivitisbirch allergenenvironmental exposure chamberfluorometholoneN-acetyl aspartyl glutamic acid

Identifiers

PMID35302688
PMCPMC9544405
OpenAlexW4220784739

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.