The DEPOT Study (Dry Eye Prescription Options for Therapy)

NCT04911361 | Completed Phase 4 FDA Drug

• 1 other identifier: DEPOT 1911 OTX
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• To determine effect of dexamethasone insert

  SPEED score at Baseline and Week 2

  2 Weeks

Secondary Outcomes (4)

• To determine the effect of dexamethasone insert

  4 Weeks

• The difference in conjunctival hyperemia

  4 weeks

• The difference in tear break up time (TBUT) before and after treatment

  4 Weeks

• The difference in corneal staining before and after treament

  4 Weeks

Other Outcomes (1)

• Safety outcome measure

  At baseline, 2 weeks, and 4 weeks

Study Arms (2)

Topical loteprednol suspension in both eyes

ACTIVE COMPARATOR

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

Drug: Dexamethasone

Lower eyelid canaliculi DEXTENZA insertion (study group)

EXPERIMENTAL

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

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

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

Also known as: DEXTENZA

Lower eyelid canaliculi DEXTENZA insertion (study group); Topical loteprednol suspension in both eyes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Insight LLC: lead

Study Sites (3)

Inland Eye Specialists

Hemet, California, 92545, United States

Location

Harvard Eye Associates

Laguna Hills, California, 92653, United States

Location

Ophthalmology Associates

St Louis, Missouri, 63131, United States

Location

Related Publications (2)

• 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.

  PMID: 30367938 BACKGROUND

• 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):

  BACKGROUND

Related Links

• DEXTENZA (dexamethasone insert) Prescribing Information, Ocular Therapeutix,Inc.2019

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• John Hovanesian, MD

  Research Insight LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: June 3, 2021
• Study Start: August 10, 2021
• Primary Completion: December 28, 2021
• Study Completion: December 28, 2021
• Last Updated: January 3, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (3)