Trial reportAdvances in therapy2022
Efficacy and Safety of the Long-Acting Diquafosol Ophthalmic Solution DE-089C in Patients with Dry Eye: A Randomized, Double-Masked, Placebo-Controlled Phase 3 Study.
Trial report in Advances in therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
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.
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.
Who cites it
14 citing papers in PubMed.
- Temporal changes in parameters associated with tear film stability after instillation of long-acting diquafosol ophthalmic solution in soft contact lens wearers.Japanese journal of ophthalmology · 2025Trial
- Clinical fluorescent contrast agents for image-guided surgery.Fundamental research · 2026Review
- Tear film and meibomian gland parameters associated with the effectiveness of intense pulsed light therapy for meibomian gland dysfunction.Scientific reports · 2025Article
- Characteristics of Patients with Dry Eye Who Switched from Long-Acting Ophthalmic Solution to Diquafosol Ophthalmic Solution.Journal of clinical medicine · 2025Article
- Applications of Diquafosol Sodium in Ophthalmology: A Comprehensive Review of Therapeutic Utility.Life (Basel, Switzerland) · 2025Review
- Calcium-sensing receptor (CaSR) modulates ocular surface chloride transport and its inhibition promotes ocular surface hydration.The ocular surface · 2024Article
- Management of Dry Eye Disease for Intraocular Lens Power Calculation in Cataract Surgery: A Systematic Review.Bioengineering (Basel, Switzerland) · 2024Review
- Effect of Long-Acting Diquafosol Sodium on Astigmatism Measurement Repeatability in Preoperative Cataract Cases with Dry Eyes: A Multicenter Prospective Study.Ophthalmology and therapy · 2024Article
- New advances in medical management of dry eye: optimizing treatment strategies for enhanced relief.International ophthalmology · 2024Review
- Tolerability of Diquas LX on tear film and meibomian glands findings in a real clinical scenario.PloS one · 2024Article
- Treatment of Dry Eye Disease (DED) in Asia: Strategies for Short Tear Film Breakup Time-Type DED.Pharmaceutics · 2023Review
- Molecular nature of ocular surface barrier function, diseases that affect it, and its relevance for ocular drug delivery.The ocular surface · 2023Review
- Effectiveness and Adherence of Dry Eye Patients Who Switched from Short- to Long-Acting Diquafosol Ophthalmic Solution.Journal of clinical medicine · 2023Article
- Ocular Surface Ion Transport and Dry Eye Disease.Current ophthalmology reports · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionDE-089C is a newly developed long-acting formulation of diquafosol ophthalmic solution with less frequent administration (three times daily) than the currently approved and clinically used diquafosol ophthalmic solution (six times daily), hereinafter referred to as DQS. DE-089C is desirable for achieving better patient adherence in clinical practice for dry eye therapy. The objective of this study was to confirm the efficacy and safety of DE-089C in patients with dry eye compared to placebo.
methodsThis randomized, multicenter, double-masked, placebo-controlled, parallel-group phase 3 study was conducted in Japan. Patients with aqueous-deficient dry eye satisfying Schirmer's test I results ≤ 5 mm/5 min were included. A total of 337 patients with dry eye were randomized in an equal ratio to treatment with DE-089C or placebo ophthalmic solution, three times daily for 4 weeks. The primary endpoint for efficacy was change in fluorescein corneal staining score from baseline to week 4. The incidence of adverse drug reactions was investigated for safety evaluation.
resultsThe background characteristics of patients in the two groups were similar. Primary endpoint of change in fluorescein corneal staining score at week 4 in the DE-089C group was significantly improved compared with the placebo group (least squares mean difference - 0.51, 95% CI - 0.754 to - 0.269, P < 0.0001). The secondary endpoint of the Lissamine green conjunctival staining score was also significantly improved in the DE-089C group compared to that in the placebo group, while other secondary endpoints were not achieved in this study. Commonly (incidence ≥ 1%) reported adverse drug reactions in the DE-089C group were eye irritation (3.6%) and eye discharge (1.8%) with mild severity, and the incidences of these two events were not higher than those in previous clinical studies on DQS.
conclusionThe efficacy and safety of DE-089C administered three times daily at half the dosage of DQS in patients with dry eye were confirmed in this study.
trial registrationJapan Pharmaceutical Information Center ID, JapicCTI-205177.
Indexed as
Identifiers
What OpenQuestion holds
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.