The DEPOT Study (Dry Eye Prescription Options for Therapy)

December 30, 2021 updated by: Research Insight LLC

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Hemet, California, United States, 92545
        • Inland Eye Specialists
      • Laguna Hills, California, United States, 92653
        • Harvard Eye Associates
    • Missouri
      • Saint Louis, Missouri, United States, 63131
        • Ophthalmology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • DEXTENZA
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:
  • DEXTENZA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine effect of dexamethasone insert
Time Frame: 2 Weeks
SPEED score at Baseline and Week 2
2 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the effect of dexamethasone insert
Time Frame: 4 Weeks
The difference in SPEED questionnaire scores before and 4 weeks after treatment.
4 Weeks
The difference in conjunctival hyperemia
Time Frame: 4 weeks
Slit exam to determine ocular hyperemia using the Schulze Scale before and 4 weeks after treatment
4 weeks
The difference in tear break up time (TBUT) before and after treatment
Time Frame: 4 Weeks
Reduced tear break up time (TBUT) ≤ 10 seconds
4 Weeks
The difference in corneal staining before and after treament
Time Frame: 4 Weeks
The presence of central or inferior staining defined by the Oxford Scale
4 Weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety outcome measure
Time Frame: At baseline, 2 weeks, and 4 weeks
Intraocular pressure at Baseline, Week 2 & 4
At baseline, 2 weeks, and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research Insight LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2021

Primary Completion (Actual)

December 28, 2021

Study Completion (Actual)

December 28, 2021

Study Registration Dates

First Submitted

April 2, 2021

First Submitted That Met QC Criteria

May 27, 2021

First Posted (Actual)

June 3, 2021

Study Record Updates

Last Update Posted (Actual)

January 3, 2022

Last Update Submitted That Met QC Criteria

December 30, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEPOT 1911 OTX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD results will be shared in publication.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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