Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ocular Therapeutix, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
To determine patient preference and treatment outcomes with an intracanalicular dexamethasone (0.4mg) insert compared to standard steroid drop regimen in the contralateral eye following bilateral PRK surgery.
Prospective Open-label Interventional Study Randomized, self-controlled design in which one eye (Group A) receives Dextenza and the second eye (Group B) receives prednisolone acetate 1% QID 1 week, BID 1 week following bilateral PRK surgery. All eyes will receive topical moxifloxacin QID for one week. Moxifloxacin in used post-op regardless of the research. Post-operative evaluations to be performed on Day 3 and Day 4, Month 1, and Month 3. Phone call survey to be performed on Week 2.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A Dextenza | Experimental | Will receive Dextenza post-operative |
|
| Group B Topical Prednisolone | Active Comparator | Will receive standard of care prednisolone acetate 1% QID for 1 week, BID for 1 week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextenza 0.4Mg Ophthalmic Insert | Drug | The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion. The attributes of the insert reduce the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Preference | Primary outcome of patient reference of dexamethasone insert versus topical steroid as measured by adapted Comparison of Ophthalmic Medications for Tolerability (COMToL) questionnaire. | Through Month 1 (Day 28 +/- 3 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Eyes Epithelialized at Day 3 | The percentage of eyes with fully healed epithelium at post-op day 3 | Post-Operative Day 3 |
| Percentage of Eyes Fully Epithelialized at Day 4 Postoperative |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John Berdahl, MD | Vance Thompson Vision | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vance Thompson Vision | Sioux Falls | South Dakota | 57108 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group A Dextenza | Dextenza 0.4Mg Ophthalmic Insert Contralateral Eye Study |
| FG001 | Group B Topical Prednisolone | Topical Prednisolone: Standard of care topical drop treatment Contralateral Eye Study |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | 40 Eyes of 20 Patients. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Preference | Primary outcome of patient reference of dexamethasone insert versus topical steroid as measured by adapted Comparison of Ophthalmic Medications for Tolerability (COMToL) questionnaire. | Posted | Count of Participants | Participants | Through Month 1 (Day 28 +/- 3 days) |
|
|
Data collected through 3 months.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexamethasone Insert Arm | Eyes implanted with dexamethasone insert | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keeley Boever | Vance Thompson Vision | 6053613937 | keeley.boever@vancethompsonvision.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 17, 2019 | Jul 24, 2023 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 13, 2020 | Jul 24, 2023 | ICF_002.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Topical Prednisolone | Drug | Standard of care topical drop treatment |
|
The percentage of eyes with fully healed epithelium at day 4 post-operative
| Postoperative Day 4 |
| Mean Pain Score Per Eye (Group A: Dextenza vs. Group B: Topical Steroid) | Pain score as measured by the Numerical Rating Scale (NRS) at day 3 post-operative. The rating scale is from 0-10 with 0 being no pain and 10 being severe pain. | Day 3 |
| SPEED Questionnaire Results at Baseline and Postoperative Day 28 | Patient evaluation of eye dryness measured by a modified SPEED questionnaire with a results recorded 0-28 with 28 being the most severe. | Pre-op Visit and Month 1 (Day 28) |
| Uncorrected Distance Visual Acuity | measured using the ETDRS acuity chart at 4 meters recorded in logMAR. | Month 1 and Month 3. |
| Spectacle Corrected Distance Visual Acuity at Months 1 and 3 Post-operative | Best-corrected distance visual acuity measured using ETDRS acuity chart at 4 meters, recorded in logMAR notation | Month 1 and Month 3 |
| Eyes |
|
| Participants |
| Participants |
|
| Age, Continuous | Mean | Full Range | years | Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
|
| Secondary | Percentage of Eyes Epithelialized at Day 3 | The percentage of eyes with fully healed epithelium at post-op day 3 | Posted | Count of Units | eyes | Post-Operative Day 3 | eyes | eyes |
|
|
|
| Secondary | Percentage of Eyes Fully Epithelialized at Day 4 Postoperative | The percentage of eyes with fully healed epithelium at day 4 post-operative | Posted | Count of Units | eyes | Postoperative Day 4 | eyes | eyes |
|
|
|
| Secondary | Mean Pain Score Per Eye (Group A: Dextenza vs. Group B: Topical Steroid) | Pain score as measured by the Numerical Rating Scale (NRS) at day 3 post-operative. The rating scale is from 0-10 with 0 being no pain and 10 being severe pain. | Posted | Mean | Standard Deviation | score on a scale | Day 3 |
|
|
|
| Secondary | SPEED Questionnaire Results at Baseline and Postoperative Day 28 | Patient evaluation of eye dryness measured by a modified SPEED questionnaire with a results recorded 0-28 with 28 being the most severe. | Posted | Mean | Standard Deviation | score on a scale | Pre-op Visit and Month 1 (Day 28) |
|
|
|
| Secondary | Uncorrected Distance Visual Acuity | measured using the ETDRS acuity chart at 4 meters recorded in logMAR. | A total of 40 eyes of 20 participants was analyzed | Posted | Mean | Standard Deviation | logMAR | Month 1 and Month 3. | Eyes | Eyes |
|
|
|
| Secondary | Spectacle Corrected Distance Visual Acuity at Months 1 and 3 Post-operative | Best-corrected distance visual acuity measured using ETDRS acuity chart at 4 meters, recorded in logMAR notation | 40 eyes of 20 participants analyzed | Posted | Mean | Standard Deviation | logMAR | Month 1 and Month 3 | eyes | eyes |
|
|
|
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Topical Steroid Arm | Eyes implanted with topical steroid | 0 | 20 | 0 | 20 | 0 | 20 |
Not provided
Not provided
Not provided
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |