Cataract
Conditions
Brief summary
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.
Interventions
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.
DRUGTopical prednisolone acetate
Standard of care topical drop regimen with four week taper
Sponsors
Ocular Therapeutix, Inc.
Vance Thompson Vision
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients 18 years of age or older, undergoing routine, uncomplicated, sequential bilateral cataract surgery. * Willing and able to comply with clinic visits and study related procedures * Willing and able to sign the informed consent form
Exclusion criteria
* Patients under the age of 18. * Patients who are pregnant (must be ruled out in women of childbearing age with pregnancy test). * Active infectious ocular or systemic disease. * Patients with active infectious ocular or extraocular disease. * Patients actively treated with local or systemic immunosuppression including systemic corticosteroids. * Patients with known hypersensitivity to Dexamethasone. * Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator. * Patients with proliferative diabetic retinopathy or uncontrolled diabetes as deemed by an A1C \> 10.0. * Patients with a history of ocular inflammation or macular edema. * Patients with a pre-existing epiretinal membrane (ERM) * Patients with allergy or inability to receive intracameral antibiotic. * Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) greater than 1,200 mg/day The PREPARE Study (V1) February, 2021 Page 27 CONFIDENTIAL * Patients with a corticosteroid implant (i.e. Ozurdex).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Tolerability (Defined as Patient Preference) | Post-op Week 4 | 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. |
| Mean Anterior Chamber Cell/Flare Score | Post-op Day 1 | 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. |
| Number of Eyes With No Cell or Flare Measured | post-op Week 4. | 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. |
| Mean Pain Score | Post-op Day 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Increased Intraocular Pressure (IOP) >10mmHg Above Baseline | postop Day 1 | 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. |
| Number of Participants With Post-operative Cystoid Macular Edema (CME) | post-op Week 4 | Cystoid Macular Edema (CME) as measured by optical coherence tomography (OCT); Total number of study participants with post-operative CME. |
| Physician Ease of Use | Day 0 | 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. |
| Eye Drop Burden Reported by Participants | Post-op Day 7 | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
60 eyes of 30 patients enrolled
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 30 |
| 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 | 30 |
| 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 | 30 |
| Total | 120 |
Baseline characteristics
| Characteristic | Group A Dextenza | Group B Topical Prednisolone | Total |
|---|---|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 0.389 | 67 years STANDARD_DEVIATION 0.389 | 67 years STANDARD_DEVIATION 0.389 |
| Pain Score 0-10 | 2 units on a scale | 2 units on a scale | 2 units on a scale |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 17 Participants | 17 Participants | 34 Participants |
| Sex: Female, Male Male | 13 Participants | 13 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
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.
Time frame: Post-op Day 7
Population: Contralateral eye study of 30 patients. A total of 60 eyes analyzed with 30 eyes randomized to each group.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group A Dextenza | Mean Anterior Chamber Cell/Flare Score | 0.25 score on a scale |
| Group B Topical Prednisolone | Mean Anterior Chamber Cell/Flare Score | 0.22 score on a scale |
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.
Time frame: Post-op Day 1
Population: Contralateral eye study of 30 patients. A total of 60 eyes analyzed with 30 eyes randomized to each group.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group A Dextenza | Mean Anterior Chamber Cell/Flare Score | 1.06 Units on a scale |
| Group B Topical Prednisolone | Mean Anterior Chamber Cell/Flare Score | 1.15 Units on a scale |
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.
Time frame: Post-op Day 1
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A Dextenza | Mean Pain Score | Pain score 0 | 23 Participants |
| Group A Dextenza | Mean Pain Score | Pain score 3 | 2 Participants |
| Group A Dextenza | Mean Pain Score | Pain score 1 | 2 Participants |
| Group A Dextenza | Mean Pain Score | Pain score 4 | 1 Participants |
| Group A Dextenza | Mean Pain Score | Pain score 2 | 2 Participants |
| Group B Topical Prednisolone | Mean Pain Score | Pain score 4 | 0 Participants |
| Group B Topical Prednisolone | Mean Pain Score | Pain score 1 | 2 Participants |
| Group B Topical Prednisolone | Mean Pain Score | Pain score 2 | 3 Participants |
| Group B Topical Prednisolone | Mean Pain Score | Pain score 3 | 2 Participants |
| Group B Topical Prednisolone | Mean Pain Score | Pain score 0 | 23 Participants |
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.
Time frame: post-op Week 4.
Population: Contralateral eye study of 30 patients. A total of 60 eyes analyzed with 30 eyes randomized to each group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A Dextenza | Number of Eyes With No Cell or Flare Measured | 30 eyes |
| Group B Topical Prednisolone | Number of Eyes With No Cell or Flare Measured | 28 eyes |
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.
Time frame: Post-op Week 4
Population: 30 patients in each cohort or 60 eyes
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A Dextenza | Patient Tolerability (Defined as Patient Preference) | Preferred Dexamethasone Inserts | 29 Participants |
| Group A Dextenza | Patient Tolerability (Defined as Patient Preference) | Preferred Preferred topical prednisolone acetate | 0 Participants |
| Group A Dextenza | Patient Tolerability (Defined as Patient Preference) | No Preference | 1 Participants |
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.
Time frame: Post-op Day 7
Population: 1 patient did not complete questionnaire. Patients were not asked to differentiate between eyes when answering the eye drop burden questionnaire
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A Dextenza | Eye Drop Burden Reported by Participants | Low burden (maximum score between 8-18) | 27 Participants |
| Group A Dextenza | Eye Drop Burden Reported by Participants | Moderate burden (maximum score between 19-29) | 2 Participants |
| Group A Dextenza | Eye Drop Burden Reported by Participants | High burden (maximum score between 30-40) | 0 Participants |
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.
Time frame: post-op Week 4. Patients were not asked to differentiate between eyes when answering the eye drop burden questionnaire
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A Dextenza | Eye Drop Burden Reported by Participants | High burden (maximum score between 30-40) | 0 Participants |
| Group A Dextenza | Eye Drop Burden Reported by Participants | Low burden (maximum score between 8-18) | 28 Participants |
| Group A Dextenza | Eye Drop Burden Reported by Participants | Moderate burden (maximum score between 19-29) | 2 Participants |
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.
Time frame: postop Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A Dextenza | Number of Participants With Increased Intraocular Pressure (IOP) >10mmHg Above Baseline | 1 Participants |
| Group B Topical Prednisolone | Number of Participants With Increased Intraocular Pressure (IOP) >10mmHg Above Baseline | 0 Participants |
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.
Time frame: Postop Day 7
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A Dextenza | Number of Participants With Increased Intraocular Pressure (IOP) >10mmHg Above Baseline | 0 Participants |
| Group B Topical Prednisolone | Number of Participants With Increased Intraocular Pressure (IOP) >10mmHg Above Baseline | 0 Participants |
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.
Time frame: postop Week 4
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A Dextenza | Number of Participants With Increased Intraocular Pressure (IOP) >10mmHg Above Baseline | 0 Participants |
| Group B Topical Prednisolone | Number of Participants With Increased Intraocular Pressure (IOP) >10mmHg Above Baseline | 0 Participants |
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.
Time frame: post-op Week 4
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A Dextenza | Number of Participants With Post-operative Cystoid Macular Edema (CME) | 0 Participants |
| Group B Topical Prednisolone | Number of Participants With Post-operative Cystoid Macular Edema (CME) | 0 Participants |
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.
Time frame: Day 0
Population: Not applicable to Group B
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group A Dextenza | Physician Ease of Use | 3.9 Score on a scale |