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Per sponsor decision due to lengthy enrollment period
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| Name | Class |
|---|---|
| Ocular Therapeutix, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dextenza (IDI) (Sustained Release Dexamethasone, (0.4 mg) | Active Comparator | intracanalicular dexamethasone insert |
|
| ProLong™ collagen plugs | Placebo Comparator | collagen plug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextenza (IDI) (Sustained Release Dexamethasone), (0.4 mg) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ocular inflammation | As measured by change to dendritic cell density and ocular redness | Change from Baseline one month after intracanalicular insert implantation or punctal plug |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Parameter: Ocular Surface Disease Index (OSDI) | 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 | Change from Baseline one month after intracanalicular insert implantation or punctal plug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pedram Hamrah, MD | Tufts Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 10, 2025 | Dec 30, 2025 | 7 | ||
| Jan 6, 2026 |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| ProLong™ collagen plugs | Other | The long term synthetic punctal plug is composed of an absorbable copolymer material and measures 0.4mm in diameter and 2.0mm in length. |
|
| Clinical Parameter: Ocular Pain Assessment Survey (OPAS) | 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.) | Change from Baseline one month after intracanalicular insert implantation or punctal plug |
| Clinical Parameter: Symptom Assessment in Dry Eye scores (SANDE) | Score is calculated by multiplying the frequency of symptoms score with the severity of symptoms score and obtaining the square root. | Change from Baseline one month after intracanalicular insert implantation or punctal plug |
| Clinical Parameter: Tear Break Up Time (TBUT) | 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. | Change from Baseline one month after intracanalicular insert implantation or punctal plug |
| Clinical Parameter: Conjunctival staining | 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. | Change from Baseline one month after intracanalicular insert implantation or punctal plug |
| Clinical Parameter: Corneal staining with fluorescein | 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. | Change from Baseline one month after intracanalicular insert implantation or punctal plug |
| Clinical Parameter: Schirmer II test | Aqueous tear production will be measured by the length in millimeters that the strip wets during 5 minutes. | Change from Baseline one month after intracanalicular insert implantation or punctal plug |
| Jan 22, 2026 |
| 8 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |