Dry Eye Syndromes
Conditions
Brief summary
To evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert in patients with dry eye who are beginning treatment with Xiidra (lifitegrast ophthalmic solution) to reduce the signs and symptoms of dry eye disease.
Detailed description
This prospective study will use a fellow-eye design for 20 participants, 40 eyes. All eyes will receive bilateral Xiidra. The most symptomatic eye will be selected to receive DEXTENZA® insertion on the day Xiidra is prescribed (study eye), while the other eye will be assigned to receive sham punctum dilation (control eye). If there is no obvious symptomatic difference, the right eye will receive the intracanalicular insert. The study group will consist of 20 eyes receiving DEXTENZA® insertion. The control group will consist of 20 eyes receiving sham punctum dilation. Thus, for every eye in the study group, there will be a paired eye with similar baseline characteristics in the control group sourced from the same participant. This fellow-eye design allows for greater control of potential confounders tied to participants' systemic and ocular health.
Interventions
To reduce signs and symptoms of dry eye disease
DRUGDexamethasone Intracanalicular Insert, 0.4mg with Lifitegrast 5% Ophthalmic Solution
To determine the outcomes of reduction of signs and symptoms of dry eye disease with DEXTENZA as an added therapy, in addition to Xiidra therapy.
Sponsors
Ocular Therapeutix, Inc.
Eye Surgeons of Indiana
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
A patient's study eye must meet the following criteria to be eligible for inclusion in the study: * 18 years of age or older * Signs and symptoms of DED * Consent to treat with topical immunomodulator * Willing and able to comply with clinic visits and study related procedures * Willing and able to sign the informed consent form
Exclusion criteria
A patient who meets any of the following criteria will be excluded from the study: * Patients under the age of 18. * Pregnancy (must be ruled out in women of child-bearing age with pregnancy test) * Active infectious systemic disease * Active infectious ocular or extraocular disease * Altered nasolacrimal flow of either acquired, induced, or congenital origin * Hypersensitivity to dexamethasone * Patients who have been on topical immunomodulating agents in the previous 3 months to their baseline visit * Patient being treated with either topical, oral, or intravenous immunosuppressive agents, immunomodulating agents, or steroid (including NSAIDS) * Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in ocular surface staining | Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit | As measured by sodium fluorescein and lissamine green |
| Patient Preference for therapy | Assessed at Week 12 Visit | As measured by COMTOL Survey |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in conjunctival injection | Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit | As measured on a scale of 0-4 and graded by the physician |
| Change from baseline in meibomian gland scores (expressibility and quality) | Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit | As measured on a grading scale 1 to 4 and graded by the physician |
| Mean change in MMP-9 | Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit | As measure by InflammaDry |
| Mean change in DEQ-5 | Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit | As measured by the DEQ-5 Questionnaire |
| Mean change in Best-corrected Visual Acuity (BCVA) | Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit | As measure by ETDRS |
| Mean change in tear osmolarity | Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit | As measured by Tear Lab |
| Mean change in tear break-up time (TBUT) | Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit | As measured by TBUT testing |
Countries
United States
Outcome results
None listed