Trial Outcomes & Findings for Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery (NCT NCT04200651)

NCT ID: NCT04200651

Last Updated: 2024-01-31

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

25 participants

Primary outcome timeframe

1 month postop, 3 months postop

Results posted on

2024-01-31

Participant Flow

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.

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	14 14	10 10
Overall Study COMPLETED	11 11	5 5
Overall Study NOT COMPLETED	3 3	5 5

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Moved to another country during follow-up	2	2
Overall Study Lost to Follow-up	1	3

Baseline Characteristics

Rows have been split into single eyes (eyes from individual participants) and fellow-eyes (eyes from the same participants).

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 1 month postop, 3 months postop

Population: Change in IOP from baseline at months 1 and 3 were compared between groups.

Outcome measures

Outcome measures
Measure	DEXTENZA® Arm n=11 Eyes 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.	Prednisolone Acetate 1% Arm n=5 Eyes 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.
Change in Intraocular Pressure (IOP) at 1 and 3 Months Change in IOP by Month 1	-2.89 mmHg Standard Deviation 2.37	-6.60 mmHg Standard Deviation 3.29
Change in Intraocular Pressure (IOP) at 1 and 3 Months Change in IOP by Month 3	-2.05 mmHg Standard Deviation 3.30	-4.6 mmHg Standard Deviation 3.29

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	DEXTENZA® Arm n=11 Eyes 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.	Prednisolone Acetate 1% Arm n=5 Eyes 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.
Change in Best-corrected Visual Acuity (BCVA) at 1 and 3 Months LogMAR change by Month 1	-0.60 logMAR Standard Deviation 0.63	-0.16 logMAR Standard Deviation 0.21
Change in Best-corrected Visual Acuity (BCVA) at 1 and 3 Months LogMAR change by Month 3	-0.53 logMAR Standard Deviation 0.66	-0.20 logMAR Standard Deviation 0.31

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	DEXTENZA® Arm n=12 Eyes 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.	Prednisolone Acetate 1% Arm n=6 Eyes 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.
Difference in Eyes With Adverse Events Between Groups	3 Number of eyes with adverse events	0 Number of eyes with adverse events

PRIMARY outcome

Timeframe: 3 months postop

Population: Change in number of glaucoma medications between groups from baseline to month 3 were compared.

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.

Outcome measures

Outcome measures
Measure	DEXTENZA® Arm n=11 Eyes 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.	Prednisolone Acetate 1% Arm n=5 Eyes 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.
Difference in Number of Glaucoma Medications at 3 Months	-0.45 number of medications Standard Deviation 0.69	-0.60 number of medications Standard Deviation 0.89

SECONDARY outcome

Timeframe: 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.

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®

Outcome measures

Outcome measures
Measure	DEXTENZA® Arm n=12 Eyes 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.	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.
Percentage of Eyes Requiring Supplemental Prednisolone Acetate 1% Eye Drops	25 Percentage of eyes	—

SECONDARY outcome

Timeframe: 3 months postop

Using the number of CME cases in each arm, as visualized by OCT, to compare safety and effectiveness between arms

Outcome measures

Outcome measures
Measure	DEXTENZA® Arm n=11 Eyes 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.	Prednisolone Acetate 1% Arm n=5 Eyes 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.
Number of Eyes With Presenting With Cystoid Macular Edema (CME) as Seen on Optical Coherence Tomography (OCT)	0 Eyes	0 Eyes

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	DEXTENZA® Arm n=8 Eyes 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.	Prednisolone Acetate 1% Arm n=2 Eyes 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.
Difference in Ocular Comfort Index (OCI) Score at 1 Month	25.96 score on a scale Standard Deviation 12.50	10.71 score on a scale Standard Deviation 15.15

SECONDARY outcome

Timeframe: 3 months postop

Population: Scores were compared between groups at month 3. Higher scores correspond to greater ocular discomfort.

Outcome measures

Outcome measures
Measure	DEXTENZA® Arm n=11 Eyes 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.	Prednisolone Acetate 1% Arm n=5 Eyes 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.
Difference in Ocular Comfort Index (OCI) Score at 3 Months	21.20 score on a scale Standard Deviation 14.67	16.32 score on a scale Standard Deviation 16.49

SECONDARY outcome

Timeframe: 1 month postop

Population: Counts indicate the number of eyes with no AC cell or flare present at 1 month follow-up.

Comparing the number of eyes with complete AC clearance of inflammatory cells, as determined by slit lamp exam, between arms to evaluate drug effectiveness

Outcome measures

Outcome measures
Measure	DEXTENZA® Arm n=9 Eyes 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.	Prednisolone Acetate 1% Arm n=5 Eyes 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.
Difference in Number of Eyes With Absence of Anterior Chamber (AC) Cells at 1 Month	7 Eyes	5 Eyes

Adverse Events

DEXTENZA® Arm

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Prednisolone Acetate 1% Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	DEXTENZA® Arm n=12 participants at risk 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.	Prednisolone Acetate 1% Arm n=6 participants at risk 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.
Eye disorders Eye pain with movement and lid twitching	8.3% 1/12 • Number of events 1 • From baseline visit through 3 months of follow-up, the final study visit As mentioned previously in the results section, the number of eyes analyzed differs from the "started" row in Participant Flow Overview. Though 24 eyes were consented and met retention criteria, 6 eyes dropped out prior to complete baseline assessment and prior to surgery. Thus, there were 18 eyes "at risk" because only 18 eyes were operated on.	0.00% 0/6 • From baseline visit through 3 months of follow-up, the final study visit As mentioned previously in the results section, the number of eyes analyzed differs from the "started" row in Participant Flow Overview. Though 24 eyes were consented and met retention criteria, 6 eyes dropped out prior to complete baseline assessment and prior to surgery. Thus, there were 18 eyes "at risk" because only 18 eyes were operated on.
Eye disorders Hyphema and shallow iris	8.3% 1/12 • Number of events 1 • From baseline visit through 3 months of follow-up, the final study visit As mentioned previously in the results section, the number of eyes analyzed differs from the "started" row in Participant Flow Overview. Though 24 eyes were consented and met retention criteria, 6 eyes dropped out prior to complete baseline assessment and prior to surgery. Thus, there were 18 eyes "at risk" because only 18 eyes were operated on.	0.00% 0/6 • From baseline visit through 3 months of follow-up, the final study visit As mentioned previously in the results section, the number of eyes analyzed differs from the "started" row in Participant Flow Overview. Though 24 eyes were consented and met retention criteria, 6 eyes dropped out prior to complete baseline assessment and prior to surgery. Thus, there were 18 eyes "at risk" because only 18 eyes were operated on.
Eye disorders Floaters	8.3% 1/12 • Number of events 1 • From baseline visit through 3 months of follow-up, the final study visit As mentioned previously in the results section, the number of eyes analyzed differs from the "started" row in Participant Flow Overview. Though 24 eyes were consented and met retention criteria, 6 eyes dropped out prior to complete baseline assessment and prior to surgery. Thus, there were 18 eyes "at risk" because only 18 eyes were operated on.	0.00% 0/6 • From baseline visit through 3 months of follow-up, the final study visit As mentioned previously in the results section, the number of eyes analyzed differs from the "started" row in Participant Flow Overview. Though 24 eyes were consented and met retention criteria, 6 eyes dropped out prior to complete baseline assessment and prior to surgery. Thus, there were 18 eyes "at risk" because only 18 eyes were operated on.

Additional Information

Dr. Nicholas Tan

New York Eye Surgery Center; University of Colorado

Phone: 3476175971

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place