The DEPOT Study (Dry Eye Prescription Options for Therapy)

Study Overview
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Brief Summary
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Assessing DEXTENZA efficacy and safety when placed within the lower eyelid canaliculus for dry eye flares in comparison to topical loteprednol suspension.

Detailed Description
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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.

Official Title
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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
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Dry Eye

Intervention / Treatment
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* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a multicenter, prospective, randomized controlled, open label study of the efficacy of relieving both signs and symptoms of dry eye syndrome in patients with exacerbations of this disease. Patients will be randomized to receive treatment of either Dextenza or loteprednol etabonate 0.5% suspension QID for 2 weeks.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topical loteprednol suspension in both eyes<br>25 subjects will be randomized to receive treatment loteprednol etabonate 0.5% suspension QID for 2 weeks. | Drug: Dexamethasone<br>* Patients will be randomized for either topical loteprednol suspension in both eyes (control group) or lower eyelid canaliculi DEXTENZA insertion (study group)<br>* Other names: DEXTENZA;|
| Experimental: Lower eyelid canaliculi DEXTENZA insertion (study group)<br>25 subjects will be randomized to receive treatment of OTX-DED | Drug: Dexamethasone<br>* Patients will be randomized for either topical loteprednol suspension in both eyes (control group) or lower eyelid canaliculi DEXTENZA insertion (study group)<br>* Other names: DEXTENZA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine effect of dexamethasone insert | SPEED score at Baseline and Week 2 | 2 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effect of dexamethasone insert | The difference in SPEED questionnaire scores before and 4 weeks after treatment. | 4 Weeks | 
| The difference in conjunctival hyperemia | Slit exam to determine ocular hyperemia using the Schulze Scale before and 4 weeks after treatment | 4 weeks | 
| The difference in tear break up time (TBUT) before and after treatment | Reduced tear break up time (TBUT) ≤ 10 seconds | 4 Weeks | 
| The difference in corneal staining before and after treament | The presence of central or inferior staining defined by the Oxford Scale | 4 Weeks |