Trial Outcomes & Findings for The RESTORE Study, A Randomized, Controlled, Masked (Reading Center) Prospective Study (NCT NCT04396990)

Results Overview

Primary outcome of patient reference of dexamethasone insert versus topical steroid as measured by adapted Comparison of Ophthalmic Medications for Tolerability (COMToL) questionnaire.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

Through Month 1 (Day 28 +/- 3 days)

Results posted on

2024-07-30

Participant Flow

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	Group A Dextenza Dextenza 0.4Mg Ophthalmic Insert Contralateral Eye Study	Group B Topical Prednisolone Topical Prednisolone: Standard of care topical drop treatment Contralateral Eye Study
Overall Study STARTED	20 20	20 20
Overall Study COMPLETED	20 20	20 20
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The RESTORE Study, A Randomized, Controlled, Masked (Reading Center) Prospective Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=40 Eyes 40 Eyes of 20 Patients.
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
Age, Continuous	32 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 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: Through Month 1 (Day 28 +/- 3 days)

Primary outcome of patient reference of dexamethasone insert versus topical steroid as measured by adapted Comparison of Ophthalmic Medications for Tolerability (COMToL) questionnaire.

Outcome measures

Outcome measures
Measure	All Participants n=20 Participants 40 Eyes of 20 Participants.	Topical Steroid 20 eyes that were treated with topical steroid
Patient Preference Dexamethasone insert preference	14 Participants	—
Patient Preference Topical steroid preference	4 Participants	—
Patient Preference No preference	2 Participants	—

SECONDARY outcome

Timeframe: Post-Operative Day 3

The percentage of eyes with fully healed epithelium at post-op day 3

Outcome measures

Outcome measures
Measure	All Participants n=20 eyes 40 Eyes of 20 Participants.	Topical Steroid n=20 eyes 20 eyes that were treated with topical steroid
Percentage of Eyes Epithelialized at Day 3 Percent epithelialized at Day 3	20 eyes	20 eyes
Percentage of Eyes Epithelialized at Day 3 Percent not 100% epithelialized at Day 3	0 eyes	0 eyes

SECONDARY outcome

Timeframe: Postoperative Day 4

The percentage of eyes with fully healed epithelium at day 4 post-operative

Outcome measures

Outcome measures
Measure	All Participants n=20 eyes 40 Eyes of 20 Participants.	Topical Steroid n=20 eyes 20 eyes that were treated with topical steroid
Percentage of Eyes Fully Epithelialized at Day 4 Postoperative Percentage of eyes fully epithelialized at day 4	19 eyes	20 eyes
Percentage of Eyes Fully Epithelialized at Day 4 Postoperative Percentage of eyes not fully epithelialized at day 4	1 eyes	0 eyes

SECONDARY outcome

Timeframe: Day 3

Pain score as measured by the Numerical Rating Scale (NRS) at day 3 post-operative. The rating scale is from 0-10 with 0 being no pain and 10 being severe pain.

Outcome measures

Outcome measures
Measure	All Participants n=20 Participants 40 Eyes of 20 Participants.	Topical Steroid n=20 Participants 20 eyes that were treated with topical steroid
Mean Pain Score Per Eye (Group A: Dextenza vs. Group B: Topical Steroid)	0.9 score on a scale Standard Deviation 0.995	0.850 score on a scale Standard Deviation 0.853

SECONDARY outcome

Timeframe: Pre-op Visit and Month 1 (Day 28)

Patient evaluation of eye dryness measured by a modified SPEED questionnaire with a results recorded 0-28 with 28 being the most severe.

Outcome measures

Outcome measures
Measure	All Participants n=20 Participants 40 Eyes of 20 Participants.	Topical Steroid n=20 Participants 20 eyes that were treated with topical steroid
SPEED Questionnaire Results at Baseline and Postoperative Day 28 Day 28	4.00 score on a scale Standard Deviation 4.07	4.22 score on a scale Standard Deviation 4.98
SPEED Questionnaire Results at Baseline and Postoperative Day 28 Baseline	3.75 score on a scale Standard Deviation 4.05	3.70 score on a scale Standard Deviation 4.11

SECONDARY outcome

Timeframe: Month 1 and Month 3.

Population: A total of 40 eyes of 20 participants was analyzed

measured using the ETDRS acuity chart at 4 meters recorded in logMAR.

Outcome measures

Outcome measures
Measure	All Participants n=20 Eyes 40 Eyes of 20 Participants.	Topical Steroid n=20 Eyes 20 eyes that were treated with topical steroid
Uncorrected Distance Visual Acuity Uncorrected distance visual acuity at month 1	0.0005 logMAR Standard Deviation 0.121	-0.073 logMAR Standard Deviation 0.067
Uncorrected Distance Visual Acuity Uncorrected distance visual acuity at month 3	-1.117 logMAR Standard Deviation 0.068	-0.153 logMAR Standard Deviation 0.057

SECONDARY outcome

Timeframe: Month 1 and Month 3

Population: 40 eyes of 20 participants analyzed

Best-corrected distance visual acuity measured using ETDRS acuity chart at 4 meters, recorded in logMAR notation

Outcome measures

Outcome measures
Measure	All Participants n=20 eyes 40 Eyes of 20 Participants.	Topical Steroid n=20 eyes 20 eyes that were treated with topical steroid
Spectacle Corrected Distance Visual Acuity at Months 1 and 3 Post-operative Month 1	-0.051 logMAR Standard Deviation 0.066	-0.093 logMAR Standard Deviation 0.050
Spectacle Corrected Distance Visual Acuity at Months 1 and 3 Post-operative Month 3	-0.146 logMAR Standard Deviation 0.043	-0.167 logMAR Standard Deviation 0.044

Adverse Events

Dexamethasone Insert Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Topical Steroid 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

Adverse event data not reported

Additional Information

Keeley Boever

Vance Thompson Vision

Phone: 6053613937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place