Dry Eye
Conditions
Brief summary
This prospective, single-center, randomized, double-masked, parallel comparison, sponsored study seeks to investigate the efficacy of Intracanalicular dexamethasone Insert (IDI) on ameliorating the signs and symptoms of dry eye disease.
Interventions
DRUGDextenza (IDI) (Sustained Release Dexamethasone), (0.4 mg)
Intracanalicular dexamethasone insert contains 0.4 mg dexamethasone and is designed to provide a sustained and tapered release of therapeutic levels of dexamethasone to the ocular surface for up to 30 days for the reduction of postsurgical inflammation and pain associated with ocular surgery.
OTHERProLong™ collagen plugs
The long term synthetic punctal plug is composed of an absorbable copolymer material and measures 0.4mm in diameter and 2.0mm in length.
Sponsors
Ocular Therapeutix, Inc.
Tufts Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Dry Eye Disease * Objective Signs (Schirmer's II test \<10 mm at 5 min; Tear Break-Up time (TBUT) of \<10 seconds in 1 eye; corneal fluorescein staining of .=4 in at least 1 eye; conjunctival lissamine green staining of the nasal and temporal conjunctive \>=4 in at least 1 eye) * Ocular inflammation presence confirmed by In-Vivo Confocal Microscopy
Exclusion criteria
* History of Diabetes * History of ocular surgery, corneal infection, or corneal injury within the last 3 months * Active ocular allergies * Active ocular infection * Allergic to benzalkonium chloride
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in ocular inflammation | Change from Baseline one month after intracanalicular insert implantation or punctal plug | As measured by change to dendritic cell density and ocular redness |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Parameter: Ocular Pain Assessment Survey (OPAS) | Change from Baseline one month after intracanalicular insert implantation or punctal plug | 32-questions, 8-domain questionnaire using numerical rating scales to assess eye pain intensity (worse eye) in the past 24 hours and 2 weeks (worst, least and average pain intensity), frequency of eye and non-eye pain (past 24 hours and 2 weeks), non-eye pain intensity (past 24 hours and 2 weeks), impact on QoL, pre-occupation with eye and non-eye pain, aggravating factors and associated factors.) |
| Clinical Parameter: Symptom Assessment in Dry Eye scores (SANDE) | Change from Baseline one month after intracanalicular insert implantation or punctal plug | Score is calculated by multiplying the frequency of symptoms score with the severity of symptoms score and obtaining the square root. |
| Clinical Parameter: Schirmer II test | Change from Baseline one month after intracanalicular insert implantation or punctal plug | Aqueous tear production will be measured by the length in millimeters that the strip wets during 5 minutes. |
| Clinical Parameter: Ocular Surface Disease Index (OSDI) | Change from Baseline one month after intracanalicular insert implantation or punctal plug | 12-item scale; score ranges from 0 to 100 and is calculated by the sum of the scores for all 12 questions answered multiplied by 100, which is divided by the total number of questions answered times four |
| Clinical Parameter: Conjunctival staining | Change from Baseline one month after intracanalicular insert implantation or punctal plug | Grading of conjunctival lissamine green staining will be performed after 1 minutes of application of a lissamine green drop. Staining will be graded using the National Eye Institute (NEI) grading scheme, with a total range of 0-18. |
| Clinical Parameter: Corneal staining with fluorescein | Change from Baseline one month after intracanalicular insert implantation or punctal plug | Corneal fluorescein staining will be performed after 2 minutes of application of a fluorescein drop. Staining will be graded using the National Eye Institute (NEI) grading scheme, with a total range of 0-15. |
| Clinical Parameter: Tear Break Up Time (TBUT) | Change from Baseline one month after intracanalicular insert implantation or punctal plug | The standard TBUT measurement will be performed by dropping a fluorescein drop to the inferior tarsal conjunctiva and waiting 30 seconds. After several blinks, the tear film will be examined. The time lapse between the last blink and the appearance of the first randomly distributed dark discontinuity in the fluorescein stained tear film will be measured three times and the mean value of the measurements will be calculated. |
Countries
United States
Outcome results
None listed