Clinical trial NCT04911361: The DEPOT Study (Dry Eye Prescription Options for Therapy)
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye
Lead sponsor: Research Insight LLC
Sponsor class: INDUSTRY
First posted: 2021-06-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To determine effect of dexamethasone insert
timeFrame: 2 Weeks
Secondary outcomes:
measure: To determine the effect of dexamethasone insert
timeFrame: 4 Weeks
measure: The difference in conjunctival hyperemia
timeFrame: 4 weeks
measure: The difference in tear break up time (TBUT) before and after treatment
timeFrame: 4 Weeks
measure: The difference in corneal staining before and after treament
timeFrame: 4 Weeks
Other outcomes:
measure: Safety outcome measure
timeFrame: At baseline, 2 weeks, and 4 weeks
Locations:
city: Hemet
country: United States
facility: Inland Eye Specialists
state: California
city: Laguna Hills
country: United States
facility: Harvard Eye Associates
state: California
city: Saint Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
Study officials:
affiliation: Research Insight LLC
name: John Hovanesian, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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):