The DEPOT Study (Dry Eye Prescription Options for Therapy)

• Status: Recruiting
• Trial end date: 2022-08-26
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Research Insight LLC
• Treatments: Dexamethasone

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.