Trial Outcomes & Findings for Study of OMNI System in OAG (GEMINI) (NCT NCT03861169)
NCT ID: NCT03861169
Last Updated: 2024-08-14
Results Overview
Change in mean unmedicated diurnal IOP from baseline to 12 months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
209 participants
Primary outcome timeframe
12 months
Results posted on
2024-08-14
Participant Flow
Participant milestones
| Measure |
OMNI® Surgical System
Cataract extraction followed by ab-interno transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System
|
|---|---|
|
Overall Study
STARTED
|
209
|
|
Overall Study
COMPLETED
|
149
|
|
Overall Study
NOT COMPLETED
|
60
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Across three study populations (Safety/ITT, mITT, PP)
Baseline characteristics by cohort
| Measure |
OMNI® Surgical System
n=149 Participants
Eligible subjects had cataract and mild-moderate OAG with intraocular pressure (IOP) ≤33 mmHg on 1 to 4 hypotensive medications at Screening and Cataract extraction followed by ab-interno transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System
|
|---|---|
|
Age, Continuous
ITT/Safety Population
|
68.3 Years
STANDARD_DEVIATION 8.5 • n=149 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Age, Continuous
mITT
|
68.6 Years
STANDARD_DEVIATION 8.3 • n=141 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Age, Continuous
Per Protocol Population
|
68.8 Years
STANDARD_DEVIATION 8.0 • n=120 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Sex: Female, Male
ITT/Safety Population · Female
|
89 Participants
n=149 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Sex: Female, Male
ITT/Safety Population · Male
|
60 Participants
n=149 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Sex: Female, Male
mITT · Female
|
85 Participants
n=141 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Sex: Female, Male
mITT · Male
|
56 Participants
n=141 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Sex: Female, Male
Per Protocol Population · Female
|
73 Participants
n=120 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Sex: Female, Male
Per Protocol Population · Male
|
47 Participants
n=120 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Ethnicity (NIH/OMB)
ITT/Safety Population · Hispanic or Latino
|
41 Participants
n=149 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Ethnicity (NIH/OMB)
ITT/Safety Population · Not Hispanic or Latino
|
108 Participants
n=149 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Ethnicity (NIH/OMB)
ITT/Safety Population · Unknown or Not Reported
|
0 Participants
n=149 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Ethnicity (NIH/OMB)
mITT · Hispanic or Latino
|
38 Participants
n=141 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Ethnicity (NIH/OMB)
mITT · Not Hispanic or Latino
|
103 Participants
n=141 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Ethnicity (NIH/OMB)
mITT · Unknown or Not Reported
|
0 Participants
n=141 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Ethnicity (NIH/OMB)
Per Protocol · Hispanic or Latino
|
30 Participants
n=120 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Ethnicity (NIH/OMB)
Per Protocol · Not Hispanic or Latino
|
90 Participants
n=120 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Ethnicity (NIH/OMB)
Per Protocol · Unknown or Not Reported
|
0 Participants
n=120 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Race (NIH/OMB)
ITT/Safety Population · American Indian or Alaska Native
|
1 Participants
n=149 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Race (NIH/OMB)
ITT/Safety Population · Asian
|
2 Participants
n=149 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Race (NIH/OMB)
ITT/Safety Population · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=149 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Race (NIH/OMB)
ITT/Safety Population · Black or African American
|
24 Participants
n=149 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Race (NIH/OMB)
ITT/Safety Population · White
|
122 Participants
n=149 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Race (NIH/OMB)
ITT/Safety Population · More than one race
|
0 Participants
n=149 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Race (NIH/OMB)
ITT/Safety Population · Unknown or Not Reported
|
0 Participants
n=149 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Race (NIH/OMB)
mITT · American Indian or Alaska Native
|
1 Participants
n=141 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Race (NIH/OMB)
mITT · Asian
|
2 Participants
n=141 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Race (NIH/OMB)
mITT · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=141 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Race (NIH/OMB)
mITT · Black or African American
|
23 Participants
n=141 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Race (NIH/OMB)
mITT · White
|
115 Participants
n=141 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Race (NIH/OMB)
mITT · More than one race
|
0 Participants
n=141 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Race (NIH/OMB)
mITT · Unknown or Not Reported
|
0 Participants
n=141 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Race (NIH/OMB)
Per Protocol · American Indian or Alaska Native
|
1 Participants
n=120 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Race (NIH/OMB)
Per Protocol · Asian
|
0 Participants
n=120 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Race (NIH/OMB)
Per Protocol · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=120 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Race (NIH/OMB)
Per Protocol · Black or African American
|
19 Participants
n=120 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Race (NIH/OMB)
Per Protocol · White
|
100 Participants
n=120 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Race (NIH/OMB)
Per Protocol · More than one race
|
0 Participants
n=120 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Race (NIH/OMB)
Per Protocol · Unknown or Not Reported
|
0 Participants
n=120 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Region of Enrollment
United States
|
149 Participants
n=149 Participants
|
|
Study Eye
ITT/Safety Population · OD
|
74 Participants
n=149 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Study Eye
ITT/Safety Population · OS
|
75 Participants
n=149 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Study Eye
mITT · OD
|
70 Participants
n=141 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Study Eye
mITT · OS
|
71 Participants
n=141 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Study Eye
Per Protocol Population · OD
|
58 Participants
n=120 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Study Eye
Per Protocol Population · OS
|
62 Participants
n=120 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Glaucoma Status
ITT/Safety Population · Primary Open Angle Glaucoma
|
139 Participants
n=149 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Glaucoma Status
ITT/Safety Population · Pigmentary
|
1 Participants
n=149 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Glaucoma Status
ITT/Safety Population · Pseudoexfoliative
|
9 Participants
n=149 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Glaucoma Status
mITT · Primary Open Angle Glaucoma
|
131 Participants
n=141 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Glaucoma Status
mITT · Pigmentary
|
1 Participants
n=141 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Glaucoma Status
mITT · Pseudoexfoliative
|
9 Participants
n=141 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Glaucoma Status
Per Protocol Population · Primary Open Angle Glaucoma
|
113 Participants
n=120 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Glaucoma Status
Per Protocol Population · Pigmentary
|
1 Participants
n=120 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
|
Glaucoma Status
Per Protocol Population · Pseudoexfoliative
|
6 Participants
n=120 Participants • Across three study populations (Safety/ITT, mITT, PP)
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The Per Protocol (PP) analysis population was a subset of the mITT population and included all subjects who were on least one ocular hypotensive medication at screening and had uneventful cataract extraction followed by ab-interno transluminal viscoelastic delivery and trabeculotomy, 12 month IOP and medication data, and had no clinically significant protocol deviations.
Change in mean unmedicated diurnal IOP from baseline to 12 months
Outcome measures
| Measure |
Per Protocol Population
n=120 Participants
Primary inference was based on the PP population.
|
mITT
Based on mITT population.
|
|---|---|---|
|
Change in Mean Unmedicated Diurnal IOP
|
7.98 mm Hg
Standard Deviation 4.21
|
—
|
PRIMARY outcome
Timeframe: 12 monthsReduction in mean number of IOP-lowering medications from screening to 12 months
Outcome measures
| Measure |
Per Protocol Population
n=120 Participants
Primary inference was based on the PP population.
|
mITT
Based on mITT population.
|
|---|---|---|
|
Change in Mean Number of IOP-Lowering Medications
|
1.43 medications
Standard Deviation 1.14
|
—
|
SECONDARY outcome
Timeframe: 12 monthsFirst Secondary Effectiveness endpoint/Percent of eyes with a ≥20% reduction in unmedicated DIOP at 12 months
Outcome measures
| Measure |
Per Protocol Population
n=120 Participants
Primary inference was based on the PP population.
|
mITT
n=141 Participants
Based on mITT population.
|
|---|---|---|
|
Percent of Eyes With a ≥20% Reduction in Unmedicated DIOP
|
84.2 percentage of eyes
|
75.9 percentage of eyes
|
SECONDARY outcome
Timeframe: 12 monthsSecond Secondary Effectiveness Endpoint: Unmedicated DIOP ≥ 6 mmHg and ≤ 18 mmHg at 12 Months/Percent of eyes with unmedicated DIOP between 6 and 18 mmHg inclusive at 12 months
Outcome measures
| Measure |
Per Protocol Population
n=120 Participants
Primary inference was based on the PP population.
|
mITT
n=141 Participants
Based on mITT population.
|
|---|---|---|
|
Percent of Eyes With Unmedicated Diurnal IOP Between 6 and 18 mmHg Inclusive at 12 Months
|
77.5 percentage of eyes
|
70.9 percentage of eyes
|
Adverse Events
iTT/Safety
Serious events: 2 serious events
Other events: 34 other events
Deaths: 34 deaths
Serious adverse events
| Measure |
iTT/Safety
n=149 participants at risk
The ITT/Safety population, defined as all enrolled and treated subjects regardless of whether or not they had a protocol deviation, comprised 149 subjects. All safety evaluations were performed on this population.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Torn rotator cuff subsequent to fainting (Unrelated)
|
0.67%
1/149 • Number of events 1 • 12 Months
|
|
Cardiac disorders
Bradycardia (Unrelated)
|
0.67%
1/149 • Number of events 2 • 12 Months
|
Other adverse events
| Measure |
iTT/Safety
n=149 participants at risk
The ITT/Safety population, defined as all enrolled and treated subjects regardless of whether or not they had a protocol deviation, comprised 149 subjects. All safety evaluations were performed on this population.
|
|---|---|
|
Eye disorders
Posterior capsular tear
|
1.3%
2/149 • Number of events 2 • 12 Months
|
|
Eye disorders
Loss of 2 lines or more BCVA (10 or more ETDRS letters) at or after 3 months postoperative
|
1.3%
2/149 • Number of events 2 • 12 Months
|
|
Eye disorders
Chronic anterior uveitis
|
1.3%
2/149 • Number of events 3 • 12 Months
|
|
Eye disorders
Layered hyphema greater than or equal to 1mm
|
6.0%
9/149 • Number of events 9 • 12 Months
|
|
Eye disorders
Peripheral Anterior Synechiae >1 clock hour
|
1.3%
2/149 • Number of events 2 • 12 Months
|
|
Eye disorders
Vitreous hemorrhage
|
0.67%
1/149 • Number of events 1 • 12 Months
|
|
Eye disorders
Clinically significant cystoid macular edema
|
0.67%
1/149 • Number of events 1 • 12 Months
|
|
Eye disorders
Increase in C/D ratio of > 0.3 units compared to baseline on slit lamp exam
|
1.3%
2/149 • Number of events 2 • 12 Months
|
|
Eye disorders
IOP increase requiring management with systemic medication at greater than or equal to 1 month visit
|
1.3%
2/149 • Number of events 2 • 12 Months
|
|
Eye disorders
IOP increase greater than or equal to 10 mmHg above baseline IOP at greater than or equal to 1M
|
2.0%
3/149 • Number of events 3 • 12 Months
|
|
Eye disorders
Blepharitis
|
2.0%
3/149 • Number of events 3 • 12 Months
|
|
Eye disorders
Cystoid macular edema (CME)
|
1.3%
2/149 • Number of events 2 • 12 Months
|
|
Eye disorders
Dry Eye
|
0.67%
1/149 • Number of events 1 • 12 Months
|
|
Eye disorders
Guttae
|
0.67%
1/149 • Number of events 1 • 12 Months
|
|
Eye disorders
Hordeolum
|
0.67%
1/149 • Number of events 1 • 12 Months
|
|
Eye disorders
Iritis
|
1.3%
2/149 • Number of events 2 • 12 Months
|
|
Eye disorders
Microhyphema
|
1.3%
2/149 • Number of events 2 • 12 Months
|
|
Eye disorders
Ocular migraine
|
0.67%
1/149 • Number of events 1 • 12 Months
|
|
Eye disorders
Posterior capsular opacification (PCO)
|
3.4%
5/149 • Number of events 5 • 12 Months
|
|
Eye disorders
Superficial punctate keratitis (SPK)
|
0.67%
1/149 • Number of events 1 • 12 Months
|
Additional Information
Tommie Rodriguez, Senior Clinical Research Manager
Sight Sciences
Phone: 818-687-3310
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60