Trial Outcomes & Findings for Assessing Dextenza Insert After SMILE Procedure (NCT NCT04380857)

NCT ID: NCT04380857

Last Updated: 2023-10-06

Results Overview

post-op pain as measured as scores on an Ocular Pain Assessment Scale from 0-10 ("0" being no pain and "10" being the worst pain you could imagine)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: Change is being assessed at Baseline, Day 1, Day 7, Day 30 and Day 90
• Results posted on: 2023-10-06

Participant Flow

This prospective, randomized, fellow-eye controlled study was conducted at a single site (Clear Choice Custom LASIK Center) in 20 patients (40 eyes) with three surgeons between June 2020 and June 2021 and was performed according to guidelines established by the Declaration of Helsinki.

Twenty-three patients were enrolled in the study. One patient failed screening and was not randomized. Two additional patients were randomized, but the Dextenza insert could not be successfully placed in the assigned eye at the time of surgery.

Unit of analysis: Eyes

Participant milestones

Measure	Dexamethasone Ophthalmic Insert 0.4 mg Dexamethasone ophthalmic insert 0.4 mg Dexamethasone ophthalmic insert 0.4 mg: intracanalicular dexamethasone insert	Topical Prednisolone Acetate Ophthalmic Drops Topical prednisolone acetate ophthalmic drops per standard of care: Every two hours on day of procedure, then four times a day for the first week, then two times a day for the second week, then discontinue.
Overall Study STARTED	20 20	20 20
Overall Study COMPLETED	17 17	17 17
Overall Study NOT COMPLETED	3 3	3 3

Reasons for withdrawal

Measure	Dexamethasone Ophthalmic Insert 0.4 mg Dexamethasone ophthalmic insert 0.4 mg Dexamethasone ophthalmic insert 0.4 mg: intracanalicular dexamethasone insert	Topical Prednisolone Acetate Ophthalmic Drops Topical prednisolone acetate ophthalmic drops per standard of care: Every two hours on day of procedure, then four times a day for the first week, then two times a day for the second week, then discontinue.
Overall Study Lost to Follow-up	3	3

Baseline Characteristics

Assessing Dextenza Insert After SMILE Procedure

Baseline characteristics by cohort

Measure	Enrolled Patients n=20 Participants Enrolled patients who underwent SMILE surgery in both eyes with investigational treatment in one eye and standard of care treatment in the fellow eye.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: Change is being assessed at Baseline, Day 1, Day 7, Day 30 and Day 90

Population: All subjects were seen through week 1; three were lost to follow up thereafter.

post-op pain as measured as scores on an Ocular Pain Assessment Scale from 0-10 ("0" being no pain and "10" being the worst pain you could imagine)

Outcome measures

Measure	Dexamethasone Ophthalmic Insert 0.4 mg n=20 Eyes Dexamethasone ophthalmic insert 0.4 mg Dexamethasone ophthalmic insert 0.4 mg: intracanalicular dexamethasone insert	Topical Prednisolone Acetate Ophthalmic Drops n=20 Eyes Topical prednisolone acetate ophthalmic drops per standard of care: Every two hours on day of procedure, then four times a day for the first week, then two times a day for the second week, then discontinue.	No Preference No Preference
Mean Change in Pain Pre-operative	0.15 Score on a scale from 0-10 Standard Deviation 0.5	0.20 Score on a scale from 0-10 Standard Deviation 0.5	—
Mean Change in Pain Day 1	0.95 Score on a scale from 0-10 Standard Deviation 1.36	0.90 Score on a scale from 0-10 Standard Deviation 1.12	—
Mean Change in Pain Day 7	0.47 Score on a scale from 0-10 Standard Deviation 0.94	0.37 Score on a scale from 0-10 Standard Deviation 0.67	—
Mean Change in Pain Day 30	0.41 Score on a scale from 0-10 Standard Deviation 1.7	0.06 Score on a scale from 0-10 Standard Deviation 0.24	—
Mean Change in Pain Day 90	0 Score on a scale from 0-10 Standard Deviation 0	0 Score on a scale from 0-10 Standard Deviation 0	—

SECONDARY outcome

Timeframe: Baseline through Day 90

Population: All subjects were seen through week 1; three were lost to follow up thereafter.

After manifest refraction all units assessed for best corrected distance visual acuity using ETDRS. Number of lines seen was then converted to LogMar score (on a scale of -0.30 to 1.00 where smaller numbers indicate better vision and larger numbers indicate worse vision) to measure changes in Best Corrected Distance Visual Acuity between Baseline and Day 90

Outcome measures

Measure	Dexamethasone Ophthalmic Insert 0.4 mg n=17 Eyes Dexamethasone ophthalmic insert 0.4 mg Dexamethasone ophthalmic insert 0.4 mg: intracanalicular dexamethasone insert	Topical Prednisolone Acetate Ophthalmic Drops n=17 Eyes Topical prednisolone acetate ophthalmic drops per standard of care: Every two hours on day of procedure, then four times a day for the first week, then two times a day for the second week, then discontinue.	No Preference No Preference
Number of Lines Lost From Best Corrected Visual Acuity	0 Score on a scale Interval 0.0 to 0.0	0 Score on a scale Interval 0.0 to 0.0	—

SECONDARY outcome

Timeframe: Baseline to Day 7, Day 30 and Day 90

Population: All subjects were seen through week 1; three were lost to follow up thereafter.

All units assessed for uncorrected visual acuity using ETDRS. Number of lines seen was then converted to LogMar to measure changes in uncorrected visual acuity between Baseline and Day 90.

Outcome measures

Measure	Dexamethasone Ophthalmic Insert 0.4 mg n=20 Eyes Dexamethasone ophthalmic insert 0.4 mg Dexamethasone ophthalmic insert 0.4 mg: intracanalicular dexamethasone insert	Topical Prednisolone Acetate Ophthalmic Drops n=20 Eyes Topical prednisolone acetate ophthalmic drops per standard of care: Every two hours on day of procedure, then four times a day for the first week, then two times a day for the second week, then discontinue.	No Preference No Preference
Loss of Lines in Uncorrected Visual Acuity 1 week	-0.010 logMAR Standard Deviation 0.0114	0.013 logMAR Standard Deviation 0.183	—
Loss of Lines in Uncorrected Visual Acuity 1 month	-0.014 logMAR Standard Deviation 0.181	-0.026 logMAR Standard Deviation 0.160	—
Loss of Lines in Uncorrected Visual Acuity 3 months	-0.071 logMAR Standard Deviation 0.108	-0.068 logMAR Standard Deviation 0.156	—

SECONDARY outcome

Timeframe: Day 0 to Day 90

Count of participants requiring pain management from Day 0 to Day 90.

Outcome measures

Measure	Dexamethasone Ophthalmic Insert 0.4 mg n=17 Eyes Dexamethasone ophthalmic insert 0.4 mg Dexamethasone ophthalmic insert 0.4 mg: intracanalicular dexamethasone insert	Topical Prednisolone Acetate Ophthalmic Drops n=17 Eyes Topical prednisolone acetate ophthalmic drops per standard of care: Every two hours on day of procedure, then four times a day for the first week, then two times a day for the second week, then discontinue.	No Preference No Preference
Post op Pain Management Per Eye	0 Eyes	0 Eyes	—

SECONDARY outcome

Timeframe: Day 7, Day 30 and Day 90

Population: All subjects were seen through week 1; three were lost to follow up thereafter.

As reported by patients choosing one of five options; Strongly preferred insert, preferred insert, no preference, preferred standard drop regimen, strongly preferred standard drop regimen.

Outcome measures

Measure	Dexamethasone Ophthalmic Insert 0.4 mg n=20 Participants Dexamethasone ophthalmic insert 0.4 mg Dexamethasone ophthalmic insert 0.4 mg: intracanalicular dexamethasone insert	Topical Prednisolone Acetate Ophthalmic Drops n=20 Participants Topical prednisolone acetate ophthalmic drops per standard of care: Every two hours on day of procedure, then four times a day for the first week, then two times a day for the second week, then discontinue.	No Preference n=20 Participants No Preference
Patient Preference Between Groups Day 7	14 Participants	2 Participants	4 Participants
Patient Preference Between Groups Day 30	11 Participants	3 Participants	3 Participants
Patient Preference Between Groups Day 90	9 Participants	3 Participants	5 Participants

Adverse Events

Dexamethasone Ophthalmic Insert 0.4 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Topical Prednisolone Acetate Ophthalmic Drops

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Dexamethasone Ophthalmic Insert 0.4 mg n=20 participants at risk Dexamethasone ophthalmic insert 0.4 mg Dexamethasone ophthalmic insert 0.4 mg: intracanalicular dexamethasone insert	Topical Prednisolone Acetate Ophthalmic Drops n=20 participants at risk Topical prednisolone acetate ophthalmic drops per standard of care: Every two hours on day of procedure, then four times a day for the first week, then two times a day for the second week, then discontinue.
Eye disorders Intraocular pressure elevation	15.0% 3/20 • Baseline to 90 Days	0.00% 0/20 • Baseline to 90 Days

Additional Information

Kathleen Jee, MD

Cleveland Eye Clinic

Phone: 440-526-1974

Email: kjee@midwestvision.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place