An implanted dexamethasone delivery device can significantly improve symptoms associated with acute exacerbations of dry eye disease (DED), according to findings, from a multicenter, prospective, randomized controlled trial published in Clinical Ophthalmology. The insert significantly improves ocular surface health as measured by patient symptoms, corneal staining, tear breakup time, and conjunctival redness without significantly raising intraocular pressure.
The Dry Eye Prescription Options for Therapy (DEPOT) study was conducted at 3 sites in the United States. Patients (N=44) with acute exacerbations of DED were randomly assigned to receive either 0.5% loteprednol etabonate suspension 4 times daily for 4 weeks (n=24), or the OTX-DED (n=20), which delivers 0.3 mg of dexamethasone via a lower punctum insert. The primary outcome was the change from baseline in Standard Patient Evaluation of Eye Dryness (SPEED) scores at 14 days. For each patient, if both eyes met the criteria for treatment, both received allocated treatment but only the right eye was included in the analysis.
The study population comprised patients aged mean 68 (range, 40-84) years and 80% were women.
At the 2-week follow-up, all the loteprednol recipients reported good treatment compliance, but at the 4-week follow-up, 42% were not taking their medication as prescribed. For the OTX-DED recipients, the insert was not visible in the nasal canaliculus in 1 patient at both 2 and 4 weeks and in a second patient at 4 weeks.
At baseline, SPEED responses categorized patients in the intervention and control arms as having severe (85% vs 79%), moderate (15% vs 17%), and mild (0% vs 4%) DED, respectively. Severity of DED was improved compared with baseline among both groups at week 4, in which the OTX-DED and loteprednol cohorts had severe (50% vs 42%), moderate (30% vs 42%), and mild (20% vs 17%) SPEED scores (all P ≤.0005), respectively. No significant differences were observed when the interventions were compared.
Similarly, both groups had improvement in Oxford scale corneal staining scores and mean tear breakup times from baseline at 2 and 4 weeks (all P ≤.01), but no significant group differences were reported.
Intraocular pressure (IOP) significantly increased at 2 (P <.02) and 4 (P <.009) weeks among the loteprednol cohort.
“The small rise in IOP noted between baseline and weeks 2 and 4 was significant for loteprednol but not for OTX-DED,” the researchers report. “Though it is statistically significant, we do not believe this difference is clinically meaningful.”
The limitations of this study included the open-label design, small sample size, and the poor treatment compliance among the control cohort.
Disclosure: One study author declared affiliations with the biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Hovanesian JA, Keyser A, Berdy G, Sorensen R. The DEPOT study (dry eye prescription options for therapy): assessing the efficacy and safety of otx-ded (dexamethasone ophthalmic insert 0.3 mg) for intracanalicular use compared with loteprednol suspension for the treatment of episodic dry eye. Clin Ophthalmol. 2022;16:3841-3849. doi:10.2147/OPTH.S387111