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| Name | Class |
|---|---|
| Ocular Therapeutix, Inc. | INDUSTRY |
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To assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) with or without iStent/Hydrus/Goniotomy when placed in the lower punctum compared to the upper punctum.
This is a randomized, controlled study to evaluate the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) with or without iStent/Hydrus/Goniotomy when placed in the lower punctum compared to the upper punctum.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lower Punctum Insertion (Group 1) | Other | DEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use Group 1 (up to 40 eyes) will receive the insert in the lower punctum on the day of surgery in the OR. |
|
| Upper Punctum Insertion (Group 2) | Other | DEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use Group 2 (up to 40 eyes) will receive the insert in the upper punctum on the of surgery in the OR. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextenza 0.4Mg Ophthalmic Insert | Drug | (dexamethasone ophthalmic insert)-for the treatment of ocular inflammation and pain following following ophthalmic surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Complete Absence of Ocular Pain at Day 8 | Participant reported ocular pain on a scale of (0-10) with zero (0) equaling no pain and ten(10) equaling maximal pain on day 8. | at Day 8 |
| Participants With Zero Cells on Day 14 | Proportion of of participants with complete absence of anterior chamber cell at Day 14 as measured by Summed Ocular Inflammation Score (0-4). | at Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of Insertion | Rated as Easy, Moderate, Difficult | Day 0 |
| Attempts to Achieve Successful Insertion | Number of attempts to insert the dexamethasone insert in the upper or lower punctum. |
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Inclusion Criteria:
Subjects will be eligible for study participation if they:
Exclusion Criteria:
Subjects are not eligible for study participation if they:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick L Spencer, DO | Iworks Laser & Vision Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iworks Laser & Vision Center | Dayton | Ohio | 45405 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32821083 | Background | Greenwood MD, Gorham RA, Boever KR. A Randomized Fellow-Eye Clinical Trial to Evaluate Patient Preference for Dexamethasone Intracanalicular Insert or Topical Prednisolone Acetate for Control of Postoperative Symptoms Following Bilateral Femtosecond Laser in Site Keratomileusis (LASIK). Clin Ophthalmol. 2020 Aug 6;14:2223-2228. doi: 10.2147/OPTH.S265311. eCollection 2020. |
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Single medical clinic open enrollment from June-October 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lower Punctum Insertion (Group 1) | Participants undergoing cataract surgery with IOL implant with or with out Istent, Hydrus, or Goniotomy who will receive dexamethasone ophthalmic insert 0.4mg). |
| FG001 | Upper Punctum Insertion (Group 2) | Participants undergoing cataract surgery with IOL implant with or with out Istent, Hydrus, or Goniotomy who will receive dexamethasone ophthalmic insert 0.4mg). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lower Punctum Insertion (Group 1) | DEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use Group 1 (up to 40 eyes) will receive the insert in the lower punctum on the day of surgery in the OR. Dextenza 0.4Mg Ophthalmic Insert: (dexamethasone ophthalmic insert)-for the treatment of ocular inflammation and pain following following ophthalmic surgery, and ocular itching associated with allergic conjunctivitis. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age range 18-100 years old. |
| 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 | Participants With Complete Absence of Ocular Pain at Day 8 | Participant reported ocular pain on a scale of (0-10) with zero (0) equaling no pain and ten(10) equaling maximal pain on day 8. | Participants with complete absence of ocular pain at day 8 | Posted | Count of Participants | Participants | at Day 8 |
|
30 days
An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom or disease, temporally associated with the participants' participation in the research, whether or not considered related to the participant's participation on the research.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lower Punctum Insertion (Group 1) | Dexamethasone ophthalmic insert, 0.4mg intracanalicular insert in the lower punctum on the day of surgery in the OR. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased IOP | Eye disorders | Systematic Assessment | An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom or disease, temporarily associated with the participants' participation in the research. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Patrick L. Spencer | Iworks Laser and Vision Center | 937-226-7870 | iworkeye@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 26, 2022 | Jul 10, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens 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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Each subject's participation is expected to last for approximately 1 month and will be required to complete six scheduled visits over the course of the study period: Baseline (Screening Visit), Operative Visit/Insertion Day (Day 0), Day 1, Day 8, Day 14 and Day 30.
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| Day 0 |
| BG001 | Upper Punctum Insertion (Group 2) | DEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use Group 2 (up to 40 eyes) will receive the insert in the upper punctum on the of surgery in the OR. Dextenza 0.4Mg Ophthalmic Insert: (dexamethasone ophthalmic insert)-for the treatment of ocular inflammation and pain following following ophthalmic surgery, and ocular itching associated with allergic conjunctivitis. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Surgical Procedure | Count of Participants | Participants |
|
| Cataract Type | Count of Participants | Participants |
|
|
|
| Primary | Participants With Zero Cells on Day 14 | Proportion of of participants with complete absence of anterior chamber cell at Day 14 as measured by Summed Ocular Inflammation Score (0-4). | Lower and Upper Punctum Insertion | Posted | Count of Participants | Participants | at Day 14 |
|
|
|
| Secondary | Ease of Insertion | Rated as Easy, Moderate, Difficult | Easy, Moderate, Difficult. | Posted | Count of Participants | Participants | Day 0 |
|
|
|
| Secondary | Attempts to Achieve Successful Insertion | Number of attempts to insert the dexamethasone insert in the upper or lower punctum. | Attempts at Upper and Lower insertion | Posted | Count of Participants | Participants | Day 0 |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 4 |
| 39 |
| EG001 | Upper Punctum Insertion (Group 2) | Dexamethasone ophthalmic insert, 0.4mg intracanalicular insert in the lower punctum on the day of surgery in the OR. | 0 | 40 | 0 | 40 | 4 | 40 |
|
| CME | Eye disorders | Systematic Assessment | An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom or disease, temporarily associated with the participants' participation in the research. |
|
| Blurred Vision | Eye disorders | Systematic Assessment | An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom or disease, temporarily associated with the participants' participation in the research. |
|
| Anterior Chamber Inflammation | Eye disorders | Systematic Assessment | An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom or disease, temporarily associated with the participants' participation in the research. |
|
| Corneal Edema | Eye disorders | Systematic Assessment | An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom or disease, temporarily associated with the participants' participation in the research. |
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| Insert Fell Out | Eye disorders | Systematic Assessment | An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom or disease, temporarily associated with the participants' participation in the research. |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| Difficult |
|