NCT04911361CompletedPhase 4
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
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Research Insight LLC
- Enrollment
- 50
- Locations
- 3
- Primary Endpoint
- To determine effect of dexamethasone insert
Study Overview
Brief Summary
Assessing DEXTENZA efficacy and safety when placed within the lower eyelid canaliculus for dry eye flares in comparison to topical loteprednol suspension.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients 18 years and older
- •Patients willing to take an electronic survey about their tolerability of either study medication.
- •Patients with a recent exacerbation of dry eye characterized by ocular surface discomfort.
Exclusion Criteria
- •Active, systemic or local disease condition other than DES that causes clinically significant ocular surface irritation that could interfere with the evaluation and treatment of dry eye.
- •Any of the following ocular (eye or eyelid) conditions in either eye within 1 Months prior to the enrollment visit:
- •Ocular surgery (e.g., intraocular, oculoplastic, corneal or refractive surgery procedure)
- •Clinically significant ocular trauma.
- •Active ocular Herpes simplex or Herpes zoster (eye or eyelid) infection.
- •Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis)
- •Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye)
- •Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis
- •Eyelid abnormalities that significantly affect lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis)
- •Ocular surface abnormality that may compromise corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy)
- •Participation in another ophthalmic clinical trial involving a therapeutic drug or device within 30 days prior to the distribution of the survey
- •Participation in this trial in the same patient's fellow eye.
- •Patients who are pregnant or breastfeeding or who may become pregnant during participation in the study.
Arms & Interventions
Topical loteprednol suspension in both eyes
Active Comparator
25 subjects will be randomized to receive treatment loteprednol etabonate 0.5% suspension QID for 2 weeks.
Intervention: Dexamethasone (Drug)
Lower eyelid canaliculi DEXTENZA insertion (study group)
Experimental
25 subjects will be randomized to receive treatment of OTX-DED
Intervention: Dexamethasone (Drug)
Outcomes
Primary Outcomes
To determine effect of dexamethasone insert
Time Frame: 2 Weeks
SPEED score at Baseline and Week 2
Secondary Outcomes
- The difference in tear break up time (TBUT) before and after treatment(4 Weeks)
- The difference in corneal staining before and after treament(4 Weeks)
- The difference in conjunctival hyperemia(4 weeks)
- To determine the effect of dexamethasone insert(4 Weeks)
Investigators
Study Sites (3)
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