The DEPOT Study (Dry Eye Prescription Options for Therapy)
- Registration Number
- NCT04911361
- Lead Sponsor
- Research Insight LLC
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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.
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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.
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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)
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Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis
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Eyelid abnormalities that significantly affect lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis)
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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)
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Participation in another ophthalmic clinical trial involving a therapeutic drug or device within 30 days prior to the distribution of the survey
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Participation in this trial in the same patient's fellow eye.
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Patients who are pregnant or breastfeeding or who may become pregnant during participation in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lower eyelid canaliculi DEXTENZA insertion (study group) Dexamethasone 25 subjects will be randomized to receive treatment of OTX-DED Topical loteprednol suspension in both eyes Dexamethasone 25 subjects will be randomized to receive treatment loteprednol etabonate 0.5% suspension QID for 2 weeks.
- Primary Outcome Measures
Name Time Method To determine effect of dexamethasone insert 2 Weeks SPEED score at Baseline and Week 2
- Secondary Outcome Measures
Name Time Method The difference in corneal staining before and after treament 4 Weeks The presence of central or inferior staining defined by the Oxford Scale
The difference in tear break up time (TBUT) before and after treatment 4 Weeks Reduced tear break up time (TBUT) ≤ 10 seconds
The difference in conjunctival hyperemia 4 weeks Slit exam to determine ocular hyperemia using the Schulze Scale before and 4 weeks after treatment
To determine the effect of dexamethasone insert 4 Weeks The difference in SPEED questionnaire scores before and 4 weeks after treatment.
Trial Locations
- Locations (3)
Inland Eye Specialists
🇺🇸Hemet, California, United States
Harvard Eye Associates
🇺🇸Laguna Hills, California, United States
Ophthalmology Associates
🇺🇸Saint Louis, Missouri, United States
Inland Eye Specialists🇺🇸Hemet, California, United States