Status:
COMPLETED
The DEPOT Study (Dry Eye Prescription Options for Therapy)
Lead Sponsor:
Research Insight LLC
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 pl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04911361
Start Date
August 10 2021
End Date
December 28 2021
Last Update
January 3 2022
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Inland Eye Specialists
Hemet, California, United States, 92545
2
Harvard Eye Associates
Laguna Hills, California, United States, 92653
3
Ophthalmology Associates
St Louis, Missouri, United States, 63131