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| Name | Class |
|---|---|
| Ocular Therapeutix, Inc. | INDUSTRY |
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To evaluate the clinical outcomes with optometrist pre-surgical insertion of DEXTENZA in the clinical office setting in patients undergoing same-day cataract surgery compared to standard of care steroid therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A Dextenza | Experimental | Randomized to dexamethasone ophthalmic insert 0.4mg placed prior to cataract surgery, on the day of surgery. |
|
| Group B Topical Prednisolone | Active Comparator | Randomized to topical prednisolone acetate 1% four times per day for one week, three times per day for one week, two times per day for one week, and one time per day for one week starting after 4 hours after surgery. |
|
| 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 |
|---|---|---|
| Mean Anterior Chamber Cell/Flare Score | Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 +. The scale used is called the (Standardization of Uveitis Nomenclature) SUN Working Group Grading Scheme. AC cell grading schema. The SUN Working Group defined their two AC grading schemas around these two findings. Importantly, for all grading schemas discussed in this article, an improvement in inflammation is a two-step decrease in grade. A worsening of inflammation occurs with a two-step increase in grade. Grade 0 = 0 cells per high power field or HPF; Grade 0.5+ = 1-5 cells HPF; 1+ = 6-15 HPF; 2+ = 16-25 HPF; 3+ = 26-50 HPF; 4+ >50. | Post-op Day 1 |
| Mean Anterior Chamber Cell/Flare Score | Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 +. The scale used is called the (Standardization of Uveitis Nomenclature) SUN Working Group Grading Scheme. AC cell grading schema. The SUN Working Group defined their two AC grading schemas around these two findings. Importantly, for all grading schemas discussed in this article, an improvement in inflammation is a two-step decrease in grade. A worsening of inflammation occurs with a two-step increase in grade. Grade 0 = 0 cells per high power field or HPF; Grade 0.5+ = 1-5 cells HPF; 1+ = 6-15 HPF; 2+ = 16-25 HPF; 3+ = 26-50 HPF; 4+ >50. The higher the HPF, the more inflammation that can negatively impact a patient's outcome. | Post-op Day 7 |
| Number of Eyes With No Cell or Flare Measured | Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 +. The scale used is called the (Standardization of Uveitis Nomenclature) SUN Working Group Grading Scheme. AC cell grading schema. The SUN Working Group defined their two AC grading schemas around these two findings. Importantly, for all grading schemas discussed in this article, an improvement in inflammation is a two-step decrease in grade. A worsening of inflammation occurs with a two-step increase in grade. Grade 0 = 0 cells per high power field or HPF; Grade 0.5+ = 1-5 cells HPF; 1+ = 6-15 HPF; 2+ = 16-25 HPF; 3+ = 26-50 HPF; 4+ >50. The higher the HPF, the more inflammation that can negatively impact a patient's outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Increased Intraocular Pressure (IOP) >10mmHg Above Baseline | Intraocular pressure as measured by Goldmann Applanation Tonometer; Total number of Participants with Increased IOP >10mmHg above baseline. Normal intraocular pressure (IOP) is generally considered to be between 10 and 21 millimeters of mercury (mmHg). However, it's important to note that this is just a general range, and individual values can vary. A higher IOP may negatively impact a subject's outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitch Ibach, OD | Vance Thompson Vision | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vance Thompson Vision | Sioux Falls | South Dakota | 57108 | United States |
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60 eyes of 30 patients enrolled
Contralateral eye study with randomization of one eye receiving a dexamethasone ophthalmic insert 0.4mg and the other eye receiving topical prednisolone acetate 1% four times daily for one week, three times daily for one week, two times daily for one eye, and then one time daily for one week.
| ID | Title | Description |
|---|---|---|
| FG000 | Group A Dextenza Ophthalmic Insert 0.4mg | Randomized to dexamethasone ophthalmic insert 0.4mg placed prior to cataract surgery, on the day of surgery. Dextenza 0.4Mg Ophthalmic Insert: 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. |
| FG001 | Group B Topical Prednisolone Acetate 1% | Randomized to topical prednisolone acetate 1% four times per day for one week, three times per day for one week, two times per day for one week, and one time per day for one week starting after 4 hours after surgery. Topical prednisolone acetate: Standard of care topical drop regimen with four week taper |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Contralateral eye study with randomization where one eye received a dexamethasone ophthalmic insert 0.4mg and the other received topical prednisolone acetate 1% four times daily for one week, three times daily for one week, then two times daily for one week, and then one time daily for one week
| ID | Title | Description |
|---|---|---|
| BG000 | Group A Dextenza | Randomized to dexamethasone ophthalmic insert 0.4mg placed prior to cataract surgery, on the day of surgery. Dextenza 0.4Mg Ophthalmic Insert: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mean Anterior Chamber Cell/Flare Score | Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 +. The scale used is called the (Standardization of Uveitis Nomenclature) SUN Working Group Grading Scheme. AC cell grading schema. The SUN Working Group defined their two AC grading schemas around these two findings. Importantly, for all grading schemas discussed in this article, an improvement in inflammation is a two-step decrease in grade. A worsening of inflammation occurs with a two-step increase in grade. Grade 0 = 0 cells per high power field or HPF; Grade 0.5+ = 1-5 cells HPF; 1+ = 6-15 HPF; 2+ = 16-25 HPF; 3+ = 26-50 HPF; 4+ >50. | Contralateral eye study of 30 patients. A total of 60 eyes analyzed with 30 eyes randomized to each group. | Posted | Mean | Full Range | Units on a scale | Post-op Day 1 | eyes | eyes |
|
Data was collected out to 3 months post-operative
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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 | Group A Dextenza | Randomized to dexamethasone ophthalmic insert 0.4mg placed prior to cataract surgery, on the day of surgery. Dextenza 0.4Mg Ophthalmic Insert: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Vance Thompson Vision | 1-605-371-7075 | 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 | Feb 1, 2021 | Jul 24, 2023 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 3, 2021 | Jul 24, 2023 | ICF_002.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 |
| C009935 | prednisolone acetate |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Topical prednisolone acetate | Drug | Standard of care topical drop regimen with four week taper |
|
| post-op Week 4. |
| Mean Pain Score | Mean pain score measured by Visual Analog Score numerical grading scale 0(minimum)-10(maximum) 0= absence of pain 10 = highest possible pain A higher number indicates a higher pain value which may impact a subject's outcomes. | Post-op Day 1 |
| Patient Tolerability (Defined as Patient Preference) | As measured by adapted COMTOL (Comparison of Ophthalmic Medications for Tolerability) Questionnaire. The COMTOL questionnaire is designed to assess the tolerability of topical ophthalmic medications. It consists of several elements that help evaluate the frequency, severity, and impact of common side effects: Section 1: Ocular Side Effects; Section 2: Local Side Effects; Section 3: Visual Function; Section 4: Impact on Quality of Life. Likert scale is used to measure each question. 1=Never, 2=Rarely, 3=Sometimes, 4 = Often, 5= Always. A higher score suggests that the medication is less well-tolerated and may be negatively impacting the patient's daily activities and overall well-being. | Post-op Week 4 |
| postop Day 1 |
| Number of Participants With Increased Intraocular Pressure (IOP) >10mmHg Above Baseline | Intraocular pressure as measured by Goldmann Applanation Tonometer; Total number of Participants with Increased IOP >10mmHg above baseline. Normal intraocular pressure (IOP) is generally considered to be between 10 and 21 millimeters of mercury (mmHg). However, it's important to note that this is just a general range, and individual values can vary. A higher IOP may negatively impact a subject's outcome. | Postop Day 7 |
| Number of Participants With Increased Intraocular Pressure (IOP) >10mmHg Above Baseline | Intraocular Pressure as measured by Goldmann Applanation Tonometer, Total number of Participants with increased IOP > 10mmHg above baseline. Normal intraocular pressure (IOP) is generally considered to be between 10 and 21 millimeters of mercury (mmHg). However, it's important to note that this is just a general range, and individual values can vary. A higher IOP may negatively impact a subject's outcome. | postop Week 4 |
| Number of Participants With Post-operative Cystoid Macular Edema (CME) | Cystoid Macular Edema (CME) as measured by optical coherence tomography (OCT); Total number of study participants with post-operative CME. | post-op Week 4 |
| Physician Ease of Use | Physician Ease of Use Survey following dexamethasone intracanalicular placement on Surgical Visit on Scale of 0-10 with 10 being most complex (0= minimum value or not complex and 10= maximum complexity). A higher number indicates a worse outcome. | Day 0 |
| Eye Drop Burden Reported by Participants | Eye Drop Burden Questionnaire numerical grading scale 8 questions on scale of 1-5 totaling a maximum score of 40. Likert scale used: 1 Very easy, 2. Easy 3. Neither easy nor difficult 4. Difficult 5. Very difficult Low Burden=8-18 Moderate Burden=19-29 High Burden= 30-40 A higher number score indicates a negative outcome for a subject. | Post-op Day 7 |
| Eye Drop Burden Reported by Participants | Eye Drop Burden Questionnaire numerical grading scale 8 questions on scale of 1-5 totaling a maximum score of 40. Likert scale used: 1 Very easy, 2. Easy 3. Neither easy nor difficult 4. Difficult 5. Very difficult Low Burden=8-18 Moderate Burden=19-29 High Burden= 30-40 A higher score is considered a worse outcome for a subject. | post-op Week 4. Patients were not asked to differentiate between eyes when answering the eye drop burden questionnaire |
| BG001 | Group B Topical Prednisolone | Randomized to topical prednisolone acetate 1% four times per day for one week, three times per day for one week, two times per day for one week, and one time per day for one week starting after 4 hours after surgery. Topical prednisolone acetate: Standard of care topical drop regimen with four week taper |
| BG002 | Total | Total of all reporting groups |
| Eyes |
|
| years |
| Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
| Pain Score 0-10 | second measure in the primary outcome was mean pain score as measured by Visual Analog Score numerical grading scale 0-10 at post-op day 1, day 7, and week 4. | Mean | Full Range | units on a scale | Eyes |
|
|
Randomized to dexamethasone ophthalmic insert 0.4mg placed prior to cataract surgery, on the day of surgery.
Dextenza 0.4Mg Ophthalmic Insert: 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.
| OG001 | Group B Topical Prednisolone | Randomized to topical prednisolone acetate 1% four times per day for one week, three times per day for one week, two times per day for one week, and one time per day for one week starting after 4 hours after surgery. Topical prednisolone acetate: Standard of care topical drop regimen with four week taper |
|
|
| Primary | Mean Anterior Chamber Cell/Flare Score | Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 +. The scale used is called the (Standardization of Uveitis Nomenclature) SUN Working Group Grading Scheme. AC cell grading schema. The SUN Working Group defined their two AC grading schemas around these two findings. Importantly, for all grading schemas discussed in this article, an improvement in inflammation is a two-step decrease in grade. A worsening of inflammation occurs with a two-step increase in grade. Grade 0 = 0 cells per high power field or HPF; Grade 0.5+ = 1-5 cells HPF; 1+ = 6-15 HPF; 2+ = 16-25 HPF; 3+ = 26-50 HPF; 4+ >50. The higher the HPF, the more inflammation that can negatively impact a patient's outcome. | Contralateral eye study of 30 patients. A total of 60 eyes analyzed with 30 eyes randomized to each group. | Posted | Mean | Full Range | score on a scale | Post-op Day 7 | eyes | eyes |
|
|
|
| Primary | Number of Eyes With No Cell or Flare Measured | Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 +. The scale used is called the (Standardization of Uveitis Nomenclature) SUN Working Group Grading Scheme. AC cell grading schema. The SUN Working Group defined their two AC grading schemas around these two findings. Importantly, for all grading schemas discussed in this article, an improvement in inflammation is a two-step decrease in grade. A worsening of inflammation occurs with a two-step increase in grade. Grade 0 = 0 cells per high power field or HPF; Grade 0.5+ = 1-5 cells HPF; 1+ = 6-15 HPF; 2+ = 16-25 HPF; 3+ = 26-50 HPF; 4+ >50. The higher the HPF, the more inflammation that can negatively impact a patient's outcome. | Contralateral eye study of 30 patients. A total of 60 eyes analyzed with 30 eyes randomized to each group. | Posted | Number | eyes | post-op Week 4. | eyes | eyes |
|
|
|
| Primary | Mean Pain Score | Mean pain score measured by Visual Analog Score numerical grading scale 0(minimum)-10(maximum) 0= absence of pain 10 = highest possible pain A higher number indicates a higher pain value which may impact a subject's outcomes. | Posted | Count of Participants | Participants | Post-op Day 1 |
|
|
|
| Primary | Patient Tolerability (Defined as Patient Preference) | As measured by adapted COMTOL (Comparison of Ophthalmic Medications for Tolerability) Questionnaire. The COMTOL questionnaire is designed to assess the tolerability of topical ophthalmic medications. It consists of several elements that help evaluate the frequency, severity, and impact of common side effects: Section 1: Ocular Side Effects; Section 2: Local Side Effects; Section 3: Visual Function; Section 4: Impact on Quality of Life. Likert scale is used to measure each question. 1=Never, 2=Rarely, 3=Sometimes, 4 = Often, 5= Always. A higher score suggests that the medication is less well-tolerated and may be negatively impacting the patient's daily activities and overall well-being. | 30 patients in each cohort or 60 eyes | Posted | Count of Participants | Participants | Post-op Week 4 |
|
|
|
| Secondary | Number of Participants With Increased Intraocular Pressure (IOP) >10mmHg Above Baseline | Intraocular pressure as measured by Goldmann Applanation Tonometer; Total number of Participants with Increased IOP >10mmHg above baseline. Normal intraocular pressure (IOP) is generally considered to be between 10 and 21 millimeters of mercury (mmHg). However, it's important to note that this is just a general range, and individual values can vary. A higher IOP may negatively impact a subject's outcome. | Posted | Count of Participants | Participants | postop Day 1 |
|
|
|
| Secondary | Number of Participants With Increased Intraocular Pressure (IOP) >10mmHg Above Baseline | Intraocular pressure as measured by Goldmann Applanation Tonometer; Total number of Participants with Increased IOP >10mmHg above baseline. Normal intraocular pressure (IOP) is generally considered to be between 10 and 21 millimeters of mercury (mmHg). However, it's important to note that this is just a general range, and individual values can vary. A higher IOP may negatively impact a subject's outcome. | Posted | Count of Participants | Participants | Postop Day 7 |
|
|
|
| Secondary | Number of Participants With Increased Intraocular Pressure (IOP) >10mmHg Above Baseline | Intraocular Pressure as measured by Goldmann Applanation Tonometer, Total number of Participants with increased IOP > 10mmHg above baseline. Normal intraocular pressure (IOP) is generally considered to be between 10 and 21 millimeters of mercury (mmHg). However, it's important to note that this is just a general range, and individual values can vary. A higher IOP may negatively impact a subject's outcome. | Posted | Count of Participants | Participants | postop Week 4 |
|
|
|
| Secondary | Number of Participants With Post-operative Cystoid Macular Edema (CME) | Cystoid Macular Edema (CME) as measured by optical coherence tomography (OCT); Total number of study participants with post-operative CME. | Posted | Count of Participants | Participants | post-op Week 4 |
|
|
|
| Secondary | Physician Ease of Use | Physician Ease of Use Survey following dexamethasone intracanalicular placement on Surgical Visit on Scale of 0-10 with 10 being most complex (0= minimum value or not complex and 10= maximum complexity). A higher number indicates a worse outcome. | Not applicable to Group B | Posted | Mean | Full Range | Score on a scale | Day 0 |
|
|
|
| Secondary | Eye Drop Burden Reported by Participants | Eye Drop Burden Questionnaire numerical grading scale 8 questions on scale of 1-5 totaling a maximum score of 40. Likert scale used: 1 Very easy, 2. Easy 3. Neither easy nor difficult 4. Difficult 5. Very difficult Low Burden=8-18 Moderate Burden=19-29 High Burden= 30-40 A higher number score indicates a negative outcome for a subject. | 1 patient did not complete questionnaire. Patients were not asked to differentiate between eyes when answering the eye drop burden questionnaire | Posted | Count of Participants | Participants | Post-op Day 7 |
|
|
|
| Secondary | Eye Drop Burden Reported by Participants | Eye Drop Burden Questionnaire numerical grading scale 8 questions on scale of 1-5 totaling a maximum score of 40. Likert scale used: 1 Very easy, 2. Easy 3. Neither easy nor difficult 4. Difficult 5. Very difficult Low Burden=8-18 Moderate Burden=19-29 High Burden= 30-40 A higher score is considered a worse outcome for a subject. | Posted | Count of Participants | Participants | post-op Week 4. Patients were not asked to differentiate between eyes when answering the eye drop burden questionnaire |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Group B Topical Prednisolone | Randomized to topical prednisolone acetate 1% four times per day for one week, three times per day for one week, two times per day for one week, and one time per day for one week starting after 4 hours after surgery. Topical prednisolone acetate: Standard of care topical drop regimen with four week taper | 0 | 30 | 0 | 30 | 0 | 30 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| Pain score 2 |
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| Pain score 3 |
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| Pain score 4 |
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| Title | Measurements |
|---|---|
|