The DEPOT Study (Dry Eye Prescription Options for Therapy)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-10

Study Completion Date

2021-12-28

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.

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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.

Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Topical loteprednol suspension in both eyes

25 subjects will be randomized to receive treatment loteprednol etabonate 0.5% suspension QID for 2 weeks.

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Patients will be randomized for either topical loteprednol suspension in both eyes (control group) or lower eyelid canaliculi DEXTENZA insertion (study group)

Lower eyelid canaliculi DEXTENZA insertion (study group)

25 subjects will be randomized to receive treatment of OTX-DED

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Patients will be randomized for either topical loteprednol suspension in both eyes (control group) or lower eyelid canaliculi DEXTENZA insertion (study group)

Interventions

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Dexamethasone

Patients will be randomized for either topical loteprednol suspension in both eyes (control group) or lower eyelid canaliculi DEXTENZA insertion (study group)

Intervention Type DRUG

Other Intervention Names

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DEXTENZA

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes