Glaucoma, Cataract
Conditions
Keywords
MIGS, Minimally invasive glaucoma surgery
Brief summary
In this study, the investigators are comparing dexamethasone ophthalmic insert (DEXTENZA®) to the current standard of care, prednisolone acetate 1% eye drops, in a glaucoma population receiving both cataract and minimally-invasive glaucoma surgery (MIGS). DEXTENZA® and prednisolone acetate 1% drops are both steroids used to control inflammation after eye surgery. DEXTENZA®'s method of delivery differs by offering a sustained release of steroid that does not necessitate postoperative anti-inflammatory eye drops. The investigators hypothesize that DEXTENZA® will be as safe as prednisolone acetate 1% drops and as effective at controlling postoperative inflammation following concomitant cataract-MIGS in a glaucoma population. The investigators also hypothesize that DEXTENZA® will be preferred by patients over prednisolone acetate 1% drops.
Detailed description
Glaucoma and cataract surgery patients face an outsize postoperative burden. In addition to taking frequent anti-inflammatory eye drops, they often continue their glaucoma medications. This can cause patient confusion and nonadherence, potentially leading to poor healing, slower recovery period, and/or cystoid macular edema. DEXTENZA®, as a sustained release anti-inflammatory insert, could help preclude adherence difficulties and increase comfort by reducing eye drop load. However, glaucoma surgeons may hesitate to adopt DEXTENZA® due to concerns regarding safety with respect to elevated intraocular pressure. This prospective study will address those concerns directly, providing timely and high-quality clinical evidence comparing DEXTENZA® to standard-of-care steroid eye drops. For physicians and patients, the results of this study will prove immediately useful for therapeutic decision-making.
Interventions
DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen.
Prednisolone acetate 1% eye drops are used 2-4 times daily for 30 days as the current standard of care for treating inflammation and eye pain after cataract surgery. Prednisolone, like dexamethasone, is a steroid. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen.
Sponsors
Ocular Therapeutix, Inc.
The New York Eye Surgery Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This prospective study enrolled 29 eyes from 25 total patients. The protocol permitted some binocular enrollment from patients who met eligibility criteria in both eyes. All eligible eyes received concomitant cataract and MIGS surgery. Each eye was randomized to receive either DEXTENZA® insertion at the end of the surgery or to a standard of care prednisolone acetate 1% eye drop regimen via block randomization. All eyes received the standard of care topical ofloxacin antibiotic regimen. The experimental group consisted of the eyes receiving DEXTENZA® insertion. The control group consisted of the eyes placed on the prednisolone eye drop regimen.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Cataract surgery candidate and glaucoma present in at least one eye. * Minimally-invasive glaucoma surgery candidate in that same eye. Defined by having ocular hypertension requiring a medication, OR as by having mild, moderate, or severe glaucoma that is sufficiently stable and appropriate for operation.
Exclusion criteria
* Maintains regular use (daily or more) of systemic or ocular steroids at time of enrollment * Maintains regular use (daily or more) of systemic or ocular nonsteroidal anti-inflammatory drugs at time of enrollment * Anterior chamber cells present at time of enrollment * Recent febrile illness that precludes or delays participation for 3 months * Pregnancy or lactation * Known allergy to dexamethasone * Known allergy to prednisolone * Treatment with another investigational drug within the last 20 years * Current recreational drug use * Preexisting ocular pathology likely to confound the visual acuity or comfort endpoints including but not limited to: severe corneal scarring, ocular surface disease, diabetic retinopathy, or macular edema * Corneal or retinal procedures (laser or incisional) during the study period and 6 months prior
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Intraocular Pressure (IOP) at 1 and 3 Months | 1 month postop, 3 months postop | Using quantitative IOP readings to compare ocular safety between arms. Since the outcome examined was a change, baseline, month 1 postop, and month 3 postop data were used in the calculations. 1 month change calculation: Month 1 postop value - Baseline value 3 month change calculation: Month 3 postop value - Baseline value |
| Change in Best-corrected Visual Acuity (BCVA) at 1 and 3 Months | 1 month postop, 3 months postop | Using quantitative BCVA measurements, as determined by ETDRS chart at 4 meters, to compare ocular safety and effectiveness between arms. Since the outcome examined was a change, baseline, month 1 postop, and month 3 postop data were used in the calculations. 1 month change calculation: Month 1 postop value - Baseline value 3 month change calculation: Month 3 postop value - Baseline value |
| Difference in Eyes With Adverse Events Between Groups | Up to 3 months postop | Using the average number of eyes with adverse events that occur in each arm to compare safety between arms through 3 months of postoperative follow-up |
| Difference in Number of Glaucoma Medications at 3 Months | 3 months postop | Using the average number of glaucoma medications added or subtracted to each arm to compare safety between arms. These calculations were performed by subtracting the baseline glaucoma medications from the glaucoma medications at month 3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eyes Requiring Supplemental Prednisolone Acetate 1% Eye Drops | Up to 3 months postop | Recording the percentage of eyes in the DEXTENZA® arm that require anti-inflammatory rescue with supplemental ocular steroid. This will provide insight into anti-inflammatory effectiveness of DEXTENZA® |
| Difference in Number of Eyes With Absence of Anterior Chamber (AC) Cells at 1 Month | 1 month postop | Comparing the number of eyes with complete AC clearance of inflammatory cells, as determined by slit lamp exam, between arms to evaluate drug effectiveness |
| Number of Eyes With Presenting With Cystoid Macular Edema (CME) as Seen on Optical Coherence Tomography (OCT) | 3 months postop | Using the number of CME cases in each arm, as visualized by OCT, to compare safety and effectiveness between arms |
| Difference in Ocular Comfort Index (OCI) Score at 1 Month | 1 month postop | Using the Ocular Comfort Index survey to compare patients' self-reported ocular comfort between arms, providing insight into drug effectiveness. The minimum score is 0 and the maximum score is 100, with 100 indicating the most ocular irritation and discomfort and 0 indicating the least ocular irritation and discomfort |
| Difference in Ocular Comfort Index (OCI) Score at 3 Months | 3 months postop | Using the Ocular Comfort Index survey to compare patients' self-reported ocular comfort between arms, providing insight into drug effectiveness. The minimum score is 0 and the maximum score is 100, with 100 indicating the most ocular irritation and discomfort and 0 indicating the least ocular irritation and discomfort |
Countries
United States
Participant flow
Pre-assignment details
In total, 25 subjects contributing 29 eyes were consented for the study. Of those 29 eyes consented, 5 eyes from 5 subjects met exclusion criteria, thus leaving 24 eyes from 20 subjects who started the study as described below.
Participants by arm
| Arm | Count |
|---|---|
| DEXTENZA® Arm This arm will receive the DEXTENZA® insert after cataract surgery and MIGS.
Dexamethasone Ophthalmic Insert: DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen. | 12 |
| DEXTENZA® Arm This arm will receive the DEXTENZA® insert after cataract surgery and MIGS.
Dexamethasone Ophthalmic Insert: DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen. | 12 |
| Prednisolone Acetate 1% Arm This arm will receive the prescription for daily prednisolone acetate 1% eye drops after cataract surgery and MIGS.
Prednisolone Acetate 1% Oph Susp: Prednisolone acetate 1% eye drops are used 2-4 times daily for 30 days as the current standard of care for treating inflammation and eye pain after cataract surgery. Prednisolone, like dexamethasone, is a steroid. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen. | 6 |
| Prednisolone Acetate 1% Arm This arm will receive the prescription for daily prednisolone acetate 1% eye drops after cataract surgery and MIGS.
Prednisolone Acetate 1% Oph Susp: Prednisolone acetate 1% eye drops are used 2-4 times daily for 30 days as the current standard of care for treating inflammation and eye pain after cataract surgery. Prednisolone, like dexamethasone, is a steroid. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen. | 6 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 3 |
| Overall Study | Moved to another country during follow-up | 2 | 2 |
Baseline characteristics
| Characteristic | DEXTENZA® Arm | Prednisolone Acetate 1% Arm | Total |
|---|---|---|---|
| Age, Continuous Fellow eyes | 67 years STANDARD_DEVIATION 9.9 | 67 years STANDARD_DEVIATION 9.9 | 67 years STANDARD_DEVIATION 8.08 |
| Age, Continuous Single eyes | 70.6 years STANDARD_DEVIATION 11.65 | 73 years STANDARD_DEVIATION 6.32 | 71.3 years STANDARD_DEVIATION 10.22 |
| Central corneal thickness Fellow eyes | 492 microns STANDARD_DEVIATION 5.66 | 475 microns STANDARD_DEVIATION 4.24 | 483.5 microns STANDARD_DEVIATION 10.63 |
| Central corneal thickness Single eyes | 521.70 microns STANDARD_DEVIATION 39.88 | 534.80 microns STANDARD_DEVIATION 23.39 | 525.44 microns STANDARD_DEVIATION 35.57 |
| Cup-to-disc ratio Fellow eyes | 0.63 ratio STANDARD_DEVIATION 0.21 | 0.49 ratio STANDARD_DEVIATION 0.2 | 0.56 ratio STANDARD_DEVIATION 0.19 |
| Cup-to-disc ratio Single eyes | 0.65 ratio STANDARD_DEVIATION 0.09 | 0.67 ratio STANDARD_DEVIATION 0.07 | 0.66 ratio STANDARD_DEVIATION 0.08 |
| Glaucoma medications Fellow eyes | 1 medications STANDARD_DEVIATION 0 | 1 medications STANDARD_DEVIATION 0 | 1 medications STANDARD_DEVIATION 0 |
| Glaucoma medications Single eyes | 1.8 medications STANDARD_DEVIATION 0.92 | 1.5 medications STANDARD_DEVIATION 0.58 | 1.7 medications STANDARD_DEVIATION 0.83 |
| Glaucoma severity Fellow eyes Mild glaucoma | 0 Eyes | 1 Eyes | 1 Eyes |
| Glaucoma severity Fellow eyes Moderate glaucoma | 2 Eyes | 1 Eyes | 3 Eyes |
| Glaucoma severity Single eyes Mild glaucoma | 0 Eyes | 0 Eyes | 0 Eyes |
| Glaucoma severity Single eyes Moderate glaucoma | 10 Eyes | 4 Eyes | 14 Eyes |
| Intraocular pressure (IOP) Fellow eyes | 16 mmHg STANDARD_DEVIATION 5.66 | 16 mmHg STANDARD_DEVIATION 5.66 | 16 mmHg STANDARD_DEVIATION 4.62 |
| Intraocular pressure (IOP) Single eyes | 17.75 mmHg STANDARD_DEVIATION 1.96 | 18.75 mmHg STANDARD_DEVIATION 4.86 | 18.04 mmHg STANDARD_DEVIATION 2.89 |
| LogMAR visual acuity Fellow eyes | 0.52 logMAR STANDARD_DEVIATION 0.03 | 0.47 logMAR STANDARD_DEVIATION 0.1 | 0.50 logMAR STANDARD_DEVIATION 0.07 |
| LogMAR visual acuity Single eyes | 0.83 logMAR STANDARD_DEVIATION 0.68 | 0.58 logMAR STANDARD_DEVIATION 0.3 | 0.76 logMAR STANDARD_DEVIATION 0.6 |
| Minimally invasive glaucoma surgery (MIGS) type Fellow eyes Canaloplasty | 1 Eyes | 1 Eyes | 2 Eyes |
| Minimally invasive glaucoma surgery (MIGS) type Fellow eyes Hydrus | 1 Eyes | 1 Eyes | 2 Eyes |
| Minimally invasive glaucoma surgery (MIGS) type Fellow eyes iStent | 0 Eyes | 0 Eyes | 0 Eyes |
| Minimally invasive glaucoma surgery (MIGS) type Single eyes Canaloplasty | 7 Eyes | 2 Eyes | 9 Eyes |
| Minimally invasive glaucoma surgery (MIGS) type Single eyes Hydrus | 2 Eyes | 2 Eyes | 4 Eyes |
| Minimally invasive glaucoma surgery (MIGS) type Single eyes iStent | 1 Eyes | 0 Eyes | 1 Eyes |
| Prior glaucoma laser treatment Fellow eyes | 2 Eyes | 2 Eyes | 4 Eyes |
| Prior glaucoma laser treatment Single eyes | 3 Eyes | 0 Eyes | 3 Eyes |
| Race/Ethnicity, Customized Fellow eyes Asian | 0 Eyes | 0 Eyes | 0 Eyes |
| Race/Ethnicity, Customized Fellow eyes Black | 2 Eyes | 2 Eyes | 4 Eyes |
| Race/Ethnicity, Customized Fellow eyes Hispanic/Latino | 0 Eyes | 0 Eyes | 0 Eyes |
| Race/Ethnicity, Customized Fellow eyes White | 0 Eyes | 0 Eyes | 0 Eyes |
| Race/Ethnicity, Customized Single eyes Asian | 1 Eyes | 0 Eyes | 1 Eyes |
| Race/Ethnicity, Customized Single eyes Black | 2 Eyes | 1 Eyes | 3 Eyes |
| Race/Ethnicity, Customized Single eyes Hispanic/Latino | 6 Eyes | 2 Eyes | 8 Eyes |
| Race/Ethnicity, Customized Single eyes White | 1 Eyes | 1 Eyes | 2 Eyes |
| Region of Enrollment United States | 12 Eyes | 6 Eyes | 18 Eyes |
| Retinal nerve fiber layer (RNFL) thickness Fellow eyes | 53.5 microns STANDARD_DEVIATION 7.78 | 75 microns STANDARD_DEVIATION 2.83 | 64.25 microns STANDARD_DEVIATION 13.3 |
| Retinal nerve fiber layer (RNFL) thickness Single eyes | 72.9 microns STANDARD_DEVIATION 11.73 | 75.75 microns STANDARD_DEVIATION 17.29 | 73.71 microns STANDARD_DEVIATION 12.89 |
| Sex: Female, Male Fellow eyes Female | 2 Eyes | 2 Eyes | 4 Eyes |
| Sex: Female, Male Fellow eyes Male | 0 Eyes | 0 Eyes | 0 Eyes |
| Sex: Female, Male Single eyes Female | 5 Eyes | 3 Eyes | 8 Eyes |
| Sex: Female, Male Single eyes Male | 5 Eyes | 1 Eyes | 6 Eyes |
| Visual field mean deviation (VFMD) Fellow eyes | -4.74 dB | -2.55 dB | -3.65 dB STANDARD_DEVIATION 1.1 |
| Visual field mean deviation (VFMD) Single eyes | -8.45 dB STANDARD_DEVIATION 4.31 | -4.20 dB STANDARD_DEVIATION 4.89 | -7.24 dB STANDARD_DEVIATION 4.73 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 6 |
| other Total, other adverse events | 3 / 12 | 0 / 6 |
| serious Total, serious adverse events | 0 / 12 | 0 / 6 |
Outcome results
Primary
Change in Best-corrected Visual Acuity (BCVA) at 1 and 3 Months
Using quantitative BCVA measurements, as determined by ETDRS chart at 4 meters, to compare ocular safety and effectiveness between arms. Since the outcome examined was a change, baseline, month 1 postop, and month 3 postop data were used in the calculations. 1 month change calculation: Month 1 postop value - Baseline value 3 month change calculation: Month 3 postop value - Baseline value
Time frame: 1 month postop, 3 months postop
Population: LogMAR visual acuity changes from baseline to months 1 and 3 were compared between groups. Please note that for logMAR, lower values on the scale correspond with better visual acuity.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DEXTENZA® Arm | Change in Best-corrected Visual Acuity (BCVA) at 1 and 3 Months | LogMAR change by Month 1 | -0.60 logMAR | Standard Deviation 0.63 |
| DEXTENZA® Arm | Change in Best-corrected Visual Acuity (BCVA) at 1 and 3 Months | LogMAR change by Month 3 | -0.53 logMAR | Standard Deviation 0.66 |
| Prednisolone Acetate 1% Arm | Change in Best-corrected Visual Acuity (BCVA) at 1 and 3 Months | LogMAR change by Month 1 | -0.16 logMAR | Standard Deviation 0.21 |
| Prednisolone Acetate 1% Arm | Change in Best-corrected Visual Acuity (BCVA) at 1 and 3 Months | LogMAR change by Month 3 | -0.20 logMAR | Standard Deviation 0.31 |
Primary
Change in Intraocular Pressure (IOP) at 1 and 3 Months
Using quantitative IOP readings to compare ocular safety between arms. Since the outcome examined was a change, baseline, month 1 postop, and month 3 postop data were used in the calculations. 1 month change calculation: Month 1 postop value - Baseline value 3 month change calculation: Month 3 postop value - Baseline value
Time frame: 1 month postop, 3 months postop
Population: Change in IOP from baseline at months 1 and 3 were compared between groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DEXTENZA® Arm | Change in Intraocular Pressure (IOP) at 1 and 3 Months | Change in IOP by Month 1 | -2.89 mmHg | Standard Deviation 2.37 |
| DEXTENZA® Arm | Change in Intraocular Pressure (IOP) at 1 and 3 Months | Change in IOP by Month 3 | -2.05 mmHg | Standard Deviation 3.3 |
| Prednisolone Acetate 1% Arm | Change in Intraocular Pressure (IOP) at 1 and 3 Months | Change in IOP by Month 1 | -6.60 mmHg | Standard Deviation 3.29 |
| Prednisolone Acetate 1% Arm | Change in Intraocular Pressure (IOP) at 1 and 3 Months | Change in IOP by Month 3 | -4.6 mmHg | Standard Deviation 3.29 |
Primary
Difference in Eyes With Adverse Events Between Groups
Using the average number of eyes with adverse events that occur in each arm to compare safety between arms through 3 months of postoperative follow-up
Time frame: Up to 3 months postop
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DEXTENZA® Arm | Difference in Eyes With Adverse Events Between Groups | 3 Number of eyes with adverse events |
| Prednisolone Acetate 1% Arm | Difference in Eyes With Adverse Events Between Groups | 0 Number of eyes with adverse events |
Primary
Difference in Number of Glaucoma Medications at 3 Months
Using the average number of glaucoma medications added or subtracted to each arm to compare safety between arms. These calculations were performed by subtracting the baseline glaucoma medications from the glaucoma medications at month 3.
Time frame: 3 months postop
Population: Change in number of glaucoma medications between groups from baseline to month 3 were compared.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DEXTENZA® Arm | Difference in Number of Glaucoma Medications at 3 Months | -0.45 number of medications | Standard Deviation 0.69 |
| Prednisolone Acetate 1% Arm | Difference in Number of Glaucoma Medications at 3 Months | -0.60 number of medications | Standard Deviation 0.89 |
Secondary
Difference in Number of Eyes With Absence of Anterior Chamber (AC) Cells at 1 Month
Comparing the number of eyes with complete AC clearance of inflammatory cells, as determined by slit lamp exam, between arms to evaluate drug effectiveness
Time frame: 1 month postop
Population: Counts indicate the number of eyes with no AC cell or flare present at 1 month follow-up.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| DEXTENZA® Arm | Difference in Number of Eyes With Absence of Anterior Chamber (AC) Cells at 1 Month | 7 Eyes |
| Prednisolone Acetate 1% Arm | Difference in Number of Eyes With Absence of Anterior Chamber (AC) Cells at 1 Month | 5 Eyes |
Secondary
Difference in Ocular Comfort Index (OCI) Score at 1 Month
Using the Ocular Comfort Index survey to compare patients' self-reported ocular comfort between arms, providing insight into drug effectiveness. The minimum score is 0 and the maximum score is 100, with 100 indicating the most ocular irritation and discomfort and 0 indicating the least ocular irritation and discomfort
Time frame: 1 month postop
Population: Scores were compared between groups at month 1. Higher scores correspond to greater ocular discomfort. Of the 18 eyes that received baseline analysis and surgery, only 10 completed the month 1 OCI survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DEXTENZA® Arm | Difference in Ocular Comfort Index (OCI) Score at 1 Month | 25.96 score on a scale | Standard Deviation 12.5 |
| Prednisolone Acetate 1% Arm | Difference in Ocular Comfort Index (OCI) Score at 1 Month | 10.71 score on a scale | Standard Deviation 15.15 |
Secondary
Difference in Ocular Comfort Index (OCI) Score at 3 Months
Using the Ocular Comfort Index survey to compare patients' self-reported ocular comfort between arms, providing insight into drug effectiveness. The minimum score is 0 and the maximum score is 100, with 100 indicating the most ocular irritation and discomfort and 0 indicating the least ocular irritation and discomfort
Time frame: 3 months postop
Population: Scores were compared between groups at month 3. Higher scores correspond to greater ocular discomfort.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DEXTENZA® Arm | Difference in Ocular Comfort Index (OCI) Score at 3 Months | 21.20 score on a scale | Standard Deviation 14.67 |
| Prednisolone Acetate 1% Arm | Difference in Ocular Comfort Index (OCI) Score at 3 Months | 16.32 score on a scale | Standard Deviation 16.49 |
Secondary
Number of Eyes With Presenting With Cystoid Macular Edema (CME) as Seen on Optical Coherence Tomography (OCT)
Using the number of CME cases in each arm, as visualized by OCT, to compare safety and effectiveness between arms
Time frame: 3 months postop
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| DEXTENZA® Arm | Number of Eyes With Presenting With Cystoid Macular Edema (CME) as Seen on Optical Coherence Tomography (OCT) | 0 Eyes |
| Prednisolone Acetate 1% Arm | Number of Eyes With Presenting With Cystoid Macular Edema (CME) as Seen on Optical Coherence Tomography (OCT) | 0 Eyes |
Secondary
Percentage of Eyes Requiring Supplemental Prednisolone Acetate 1% Eye Drops
Recording the percentage of eyes in the DEXTENZA® arm that require anti-inflammatory rescue with supplemental ocular steroid. This will provide insight into anti-inflammatory effectiveness of DEXTENZA®
Time frame: Up to 3 months postop
Population: Of the 14 consented eyes in the DEXTENZA arm noted in the started row of the participant flow data table, 2 eyes met exclusion criteria, thus leaving 12 eligible eyes for further analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DEXTENZA® Arm | Percentage of Eyes Requiring Supplemental Prednisolone Acetate 1% Eye Drops | 25 Percentage of eyes |