The DEPOT Study (Dry Eye Prescription Options for Therapy)

Research Insight

Status and phase

Completed

Phase 4

Conditions

Dry Eye

Treatments

Drug: Dexamethasone

Study type

Interventional

Funder types

Industry

Identifiers

NCT04911361

DEPOT 1911 OTX

Details and patient eligibility

About

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

Full 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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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.