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The DEPOT Study (Dry Eye Prescription Options for Therapy)

Primary Purpose

Dry Eye

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Sponsored by
Research Insight LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Inland Eye Specialists
  • Harvard Eye Associates
  • Ophthalmology Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Topical loteprednol suspension in both eyes

Lower eyelid canaliculi DEXTENZA insertion (study group)

Arm Description

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

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

Outcomes

Primary Outcome Measures

To determine effect of dexamethasone insert
SPEED score at Baseline and Week 2

Secondary Outcome Measures

To determine the effect of dexamethasone insert
The difference in SPEED questionnaire scores before and 4 weeks after treatment.
The difference in conjunctival hyperemia
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
Reduced tear break up time (TBUT) ≤ 10 seconds
The difference in corneal staining before and after treament
The presence of central or inferior staining defined by the Oxford Scale

Full Information

First Posted
April 2, 2021
Last Updated
December 30, 2021
Sponsor
Research Insight LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04911361
Brief Title
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

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
August 10, 2021 (Actual)
Primary Completion Date
December 28, 2021 (Actual)
Study Completion Date
December 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Research Insight LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Topical loteprednol suspension in both eyes
Arm Type
Active Comparator
Arm Description
25 subjects will be randomized to receive treatment loteprednol etabonate 0.5% suspension QID for 2 weeks.
Arm Title
Lower eyelid canaliculi DEXTENZA insertion (study group)
Arm Type
Experimental
Arm Description
25 subjects will be randomized to receive treatment of OTX-DED
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
DEXTENZA
Intervention Description
Patients will be randomized for either topical loteprednol suspension in both eyes (control group) or lower eyelid canaliculi DEXTENZA insertion (study group)
Primary Outcome Measure Information:
Title
To determine effect of dexamethasone insert
Description
SPEED score at Baseline and Week 2
Time Frame
2 Weeks
Secondary Outcome Measure Information:
Title
To determine the effect of dexamethasone insert
Description
The difference in SPEED questionnaire scores before and 4 weeks after treatment.
Time Frame
4 Weeks
Title
The difference in conjunctival hyperemia
Description
Slit exam to determine ocular hyperemia using the Schulze Scale before and 4 weeks after treatment
Time Frame
4 weeks
Title
The difference in tear break up time (TBUT) before and after treatment
Description
Reduced tear break up time (TBUT) ≤ 10 seconds
Time Frame
4 Weeks
Title
The difference in corneal staining before and after treament
Description
The presence of central or inferior staining defined by the Oxford Scale
Time Frame
4 Weeks
Other Pre-specified Outcome Measures:
Title
Safety outcome measure
Description
Intraocular pressure at Baseline, Week 2 & 4
Time Frame
At baseline, 2 weeks, and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Hovanesian, MD
Organizational Affiliation
Research Insight LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inland Eye Specialists
City
Hemet
State/Province
California
ZIP/Postal Code
92545
Country
United States
Facility Name
Harvard Eye Associates
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Ophthalmology Associates
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD results will be shared in publication.
Citations:
PubMed Identifier
30367938
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. Erratum In: J Cataract Refract Surg. 2019 Jun;45(6):895.
Results Reference
background
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):
Results Reference
background
Links:
URL
http://www.dextenza.com/wp-content/uploads/2019/06/NDA-208742-S001-Dextenza-labeling-19Jun19.pdf
Description
DEXTENZA (dexamethasone insert) Prescribing Information, Ocular Therapeutix,Inc.2019

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The DEPOT Study (Dry Eye Prescription Options for Therapy)

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