The DEPOT Study (Dry Eye Prescription Options for Therapy)

Dry Eye Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04911361
• Other study ID #: DEPOT 1911 OTX
• Status: Completed
• Phase: Phase 4
• Start date: August 10, 2021
• Est. completion date: December 28, 2021

Study information

• Verified date: December 2021
• Source: Research Insight LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 28, 2021
• Est. primary completion date: December 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

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

Locations

Country	Name	City	State
United States	Inland Eye Specialists	Hemet	California
United States	Harvard Eye Associates	Laguna Hills	California
United States	Ophthalmology Associates	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Research Insight LLC

Country where clinical trial is conducted

United States, 

References & 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. Erratum in: J Cataract Refract Surg. 2019 Jun;45(6):895. — View 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):

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety outcome measure	Intraocular pressure at Baseline, Week 2 & 4	At baseline, 2 weeks, and 4 weeks
Primary	To determine effect of dexamethasone insert	SPEED score at Baseline and Week 2	2 Weeks
Secondary	To determine the effect of dexamethasone insert	The difference in SPEED questionnaire scores before and 4 weeks after treatment.	4 Weeks
Secondary	The difference in conjunctival hyperemia	Slit exam to determine ocular hyperemia using the Schulze Scale before and 4 weeks after treatment	4 weeks
Secondary	The difference in tear break up time (TBUT) before and after treatment	Reduced tear break up time (TBUT) = 10 seconds	4 Weeks
Secondary	The difference in corneal staining before and after treament	The presence of central or inferior staining defined by the Oxford Scale	4 Weeks

External Links

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