A Phase 4 interventional study of Dexamethasone in Dry Eye, sponsored by Research Insight LLC. Completed at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-03.
Sponsored by Research Insight LLC · Phase 4, Interventional, and Treatment
Assessing DEXTENZA efficacy and safety when placed within the lower eyelid canaliculus for dry eye flares in comparison to topical loteprednol suspension.
The DEPOT Study (Dry Eye Prescription Options for Therapy): A randomized controlled clinical trial assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg insert, when placed within the lower eye eyelid canaliculus in comparison to topical loteprednol suspension for the treatment of episodic dry eye.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Research Insight LLC is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Any of the following ocular (eye or eyelid) conditions in either eye within 1 Months prior to the enrollment visit:
25 subjects will be randomized to receive treatment loteprednol etabonate 0.5% suspension QID for 2 weeks.
Drug: Dexamethasone
25 subjects will be randomized to receive treatment of OTX-DED
Drug: Dexamethasone
Patients will be randomized for either topical loteprednol suspension in both eyes (control group) or lower eyelid canaliculi DEXTENZA insertion (study group)
Also known as: DEXTENZA
To determine effect of dexamethasone insert
SPEED score at Baseline and Week 2
Time frame: 2 Weeks
To determine the effect of dexamethasone insert
The difference in SPEED questionnaire scores before and 4 weeks after treatment.
Time frame: 4 Weeks
The difference in conjunctival hyperemia
Slit exam to determine ocular hyperemia using the Schulze Scale before and 4 weeks after treatment
Time frame: 4 weeks
The difference in tear break up time (TBUT) before and after treatment
Reduced tear break up time (TBUT) ≤ 10 seconds
Time frame: 4 Weeks
The difference in corneal staining before and after treament
The presence of central or inferior staining defined by the Oxford Scale
Time frame: 4 Weeks
Safety outcome measure
Intraocular pressure at Baseline, Week 2 \& 4
Time frame: At baseline, 2 weeks, and 4 weeks
Plan to share: Yes — IPD results will be shared in publication.
Supporting information: Study protocol
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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