The DEPOT Study (Dry Eye Prescription Options for Therapy)
Study Details
Study Description
Brief Summary
Assessing DEXTENZA efficacy and safety when placed within the lower eyelid canaliculus for dry eye flares in comparison to topical loteprednol suspension.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Topical loteprednol suspension in both eyes 25 subjects will be randomized to receive treatment loteprednol etabonate 0.5% suspension QID for 2 weeks. |
Drug: Dexamethasone
Patients will be randomized for either topical loteprednol suspension in both eyes (control group) or lower eyelid canaliculi DEXTENZA insertion (study group)
Other Names:
|
| Experimental: Lower eyelid canaliculi DEXTENZA insertion (study group) 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)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- To determine effect of dexamethasone insert [2 Weeks]
SPEED score at Baseline and Week 2
Secondary Outcome Measures
- To determine the effect of dexamethasone insert [4 Weeks]
The difference in SPEED questionnaire scores before and 4 weeks after treatment.
- The difference in conjunctival hyperemia [4 weeks]
Slit exam to determine ocular hyperemia using the Schulze Scale before and 4 weeks after treatment
- 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 corneal staining before and after treament [4 Weeks]
The presence of central or inferior staining defined by the Oxford Scale
Other Outcome Measures
- Safety outcome measure [At baseline, 2 weeks, and 4 weeks]
Intraocular pressure at Baseline, Week 2 & 4
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients 18 years and older
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Patients willing to take an electronic survey about their tolerability of either study medication.
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Patients with a recent exacerbation of dry eye characterized by ocular surface discomfort.
Exclusion Criteria:
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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:
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Ocular surgery (e.g., intraocular, oculoplastic, corneal or refractive surgery procedure)
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Clinically significant ocular trauma.
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Active ocular Herpes simplex or Herpes zoster (eye or eyelid) infection.
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Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis)
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Inland Eye Specialists | Hemet | California | United States | 92545 |
| 2 | Harvard Eye Associates | Laguna Hills | California | United States | 92653 |
| 3 | Ophthalmology Associates | Saint Louis | Missouri | United States | 63131 |
Sponsors and Collaborators
- Research Insight LLC
Investigators
- Principal Investigator: John Hovanesian, MD, Research Insight LLC
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Tyson SL, Bafna S, Gira JP, Goldberg DF, Jones JJ, Jones MP, Kim JK, Martel JM, Nordlund ML, Piovanetti-Perez IK, Singh IP, Metzinger JL, Mulani D, Sane S, Talamo JH, Goldstein MH; Dextenza Study Group. Multicenter randomized phase 3 study of a sustained-release intracanalicular dexamethasone insert for treatment of ocular inflammation and pain after cataract surgery. J Cataract Refract Surg. 2019 Feb;45(2):204-212. doi: 10.1016/j.jcrs.2018.09.023. Epub 2018 Oct 24. Erratum in: J Cataract Refract Surg. 2019 Jun;45(6):895.
- Walters TR, et al. Efficacy and Safety of Sustained Release Dexamethasone for the Treatment of Ocular Pain and Inflammation after Cataract Surgery: Results from Two Phase 3 Studies. J Clin Exp Ophthalmol. 2016; 7(4):
- DEPOT 1911 OTX