Dexamethasone Intracanalicular Insert for Clinically Significant Aqueous-Deficient Dry Eye: A Randomized Controlled Trial

Michael X Lin; Lee Guo; Ian J Saldanha; Shanna VanCourt; Julia Zeng; Sezen Karakus; Michelle Hessen; Gavin Li; Esen K Akpek

doi:10.1016/j.ophtha.2024.03.010

Dexamethasone Intracanalicular Insert for Clinically Significant Aqueous-Deficient Dry Eye: A Randomized Controlled Trial

Ophthalmology. 2024 Mar 15:S0161-6420(24)00186-6. doi: 10.1016/j.ophtha.2024.03.010. Online ahead of print.

Authors

Michael X Lin¹, Lee Guo², Ian J Saldanha³, Shanna VanCourt², Julia Zeng⁴, Sezen Karakus², Michelle Hessen², Gavin Li⁵, Esen K Akpek⁶

Affiliations

¹ The Ocular Surface Disease Clinic, The Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Maryland School of Medicine, Baltimore, Maryland.
² The Ocular Surface Disease Clinic, The Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland.
³ Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
⁴ The Ocular Surface Disease Clinic, The Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland; Stritch School of Medicine, Loyola University, Chicago, Illinois.
⁵ The Ocular Surface Disease Clinic, The Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland; Icahn School of Medicine at Mount Sinai, New York, New York.
⁶ The Ocular Surface Disease Clinic, The Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland. Electronic address: esakpek@jhmi.edu.

PMID: 38492864
DOI: 10.1016/j.ophtha.2024.03.010

Abstract

Purpose: To evaluate a commercially available dexamethasone intracanalicular insert to treat dry eye.

Design: Single-center, double-masked randomized controlled trial.

Participants: Patients with clinically significant aqueous-deficient dry eye (combined ocular surface staining score, ≥ 3 [0-12]; corneal fluorescein staining score, ≥ 2 [0-6]; and Schirmer's wetting, < 10 mm at 5 minutes in both eyes) with symptoms (dryness, eye discomfort, or visual fatigue, ≥ 30 [0-100]) despite treatment with at least 1 prescription drop and deemed candidates for topical steroid therapy.

Methods: Seventy-five adult patients were enrolled. A 1:1 randomization sequence was used to determine which eye of each patient would receive the treatment (dexamethasone 0.4-mg intracanalicular insert with 30-day elution time) or sham (collagen plug). The fellow eye received the opposite treatment. Patients were masked to treatment assignment. Follow-up visits (at weeks 2, 4, and 6) were performed by a masked investigator.

Main outcome measures: Dry eye parameters and patient symptoms were used for efficacy, and intraocular pressure (IOP) was used for safety assessment.

Results: The severity of dry eye was comparable between the treatment arms (fellow eyes) at baseline. Eyes that received the dexamethasone insert showed significantly less corneal staining at week 4 (mean difference [MD], -0.55; 95% confidence interval [CI], -0.91 to -0.19) and conjunctival staining at week 4 (MD, -0.68; 95% CI, -1.05 to -0.30) and week 6 (MD, -0.34; 95% CI, -0.65 to -0.02). Schirmer's wetting was comparable between the two treatment arms. Although the patients reported less dryness in eyes that received the insert at week 4 (MD, -5.5; 95% CI, -11.4 to 0.4), no statistically significant differences were found in any patient-reported symptoms. At week 4, dexamethasone-treated eyes were more likely to show an IOP increase (by 5-10 mmHg; 9 eyes vs. 1 eye; relative risk, 9.00; 95% CI, 1.14-71.0). All cases of increased IOP were managed with short-term topical β-blockers and subsided.

Conclusions: The dexamethasone intracanalicular insert may be considered a dropless dual treatment for clinically significant aqueous-deficient dry eye when topical steroid treatment is deemed appropriate.

Financial disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Keywords: Clinical trial; Dry eye; Treatment.