Assessing DEXTENZA efficacy and safety when placed within the lower eyelid canaliculus for dry eye flares in comparison to topical loteprednol suspension.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Patients will be randomized for either topical loteprednol suspension in both eyes (control group) or lower eyelid canaliculi DEXTENZA insertion (study group)
Inland Eye Specialists
Hemet, California, United States
Harvard Eye Associates
Laguna Hills, California, United States
Ophthalmology Associates
St Louis, Missouri, United States
To determine effect of dexamethasone insert
SPEED score at Baseline and Week 2
Time frame: 2 Weeks
To determine the effect of dexamethasone insert
The difference in SPEED questionnaire scores before and 4 weeks after treatment.
Time frame: 4 Weeks
The difference in conjunctival hyperemia
Slit exam to determine ocular hyperemia using the Schulze Scale before and 4 weeks after treatment
Time frame: 4 weeks
The difference in tear break up time (TBUT) before and after treatment
Reduced tear break up time (TBUT) ≤ 10 seconds
Time frame: 4 Weeks
The difference in corneal staining before and after treament
The presence of central or inferior staining defined by the Oxford Scale
Time frame: 4 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.