The DEPOT Study (Dry Eye Prescription Options for Therapy)

Completed · Phase 4

Conditions studied: Dry Eye

In brief

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

Key facts

Study ID

NCT04911361

Run by

Research Insight LLC

People needed

50

Starts

2021-08-10

Expected to finish

2021-12-28

Last updated by the study team

2022-01-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Inland Eye Specialists — Hemet, California, United States
• Harvard Eye Associates — Laguna Hills, California, United States
• Ophthalmology Associates — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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