Trial Outcomes & Findings for Clinical Investigation of the Bacterially-Derived Healon5 Ophthalmic Viscosurgical Device (OVD) (NCT NCT02782676)
NCT ID: NCT02782676
Last Updated: 2025-02-04
Results Overview
The cumulative rate of IOP spikes with the bacterially-derived Healon5 will be statistically non-inferior to that with the animal-derived Healon5 control using a non-inferiority margin of 10%.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
241 participants
Primary outcome timeframe
3 months
Results posted on
2025-02-04
Participant Flow
15 subjects are consented but not randomized or treated in the study. 13 subjects were randomized but did not receive study OVD in either eye.
Unit of analysis: Eyes
Participant milestones
| Measure |
Investigational Healon5 OVD (Bacterially-Derived)
Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Investigational Healon5 OVD: ophthalmic viscosurgical device
|
Approved Healon5 OVD (Animal-Derived)
Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Healon5 OVD: ophthalmic viscosurgical device
|
|---|---|---|
|
Overall Study
STARTED
|
211 211
|
210 210
|
|
Overall Study
COMPLETED
|
211 211
|
209 209
|
|
Overall Study
NOT COMPLETED
|
0 0
|
1 1
|
Reasons for withdrawal
| Measure |
Investigational Healon5 OVD (Bacterially-Derived)
Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Investigational Healon5 OVD: ophthalmic viscosurgical device
|
Approved Healon5 OVD (Animal-Derived)
Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Healon5 OVD: ophthalmic viscosurgical device
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Clinical Investigation of the Bacterially-Derived Healon5 Ophthalmic Viscosurgical Device (OVD)
Baseline characteristics by cohort
| Measure |
Subjects Received OVD (Bacterial and/or Animal-Derived)
n=213 Participants
Subject received study OVD (Bacterial and/or Animal Derived) in either eye.
(NOTE: subject numbers includes both the paired-eyes and non-paired eye participants)
|
|---|---|
|
Age, Continuous
|
68.7 years
STANDARD_DEVIATION 8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
124 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
200 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
213 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Results are based on paired-eye subjects included in the safety population, which differs from the total number of participant (paired + non-paired eyes)safety population used in the Participant Flow.
The cumulative rate of IOP spikes with the bacterially-derived Healon5 will be statistically non-inferior to that with the animal-derived Healon5 control using a non-inferiority margin of 10%.
Outcome measures
| Measure |
Investigational Healon5 OVD (Bacterially-Derived)
n=208 Participants
Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Investigational Healon5 OVD: ophthalmic viscosurgical device
|
Approved Healon5 OVD (Animal-Derived)
n=208 Participants
Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Healon5 OVD: ophthalmic viscosurgical device
|
|---|---|---|
|
Cumulative Rates of Intraocular Pressure (IOP) Spikes 30mm of Mercury (mmHg) or Greater Measured Postoperatively
|
17 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Results are based on paired-eye subjects included in the safety population, which differs from the total number of participant (paired + non-paired eyes) safety population used in the Participant Flow. ECC photos were taken outside of the 3-month visit window for two subjects; therefore, the data was excluded from the analysis.
The mean percent ECC change with the bacterially-derived Healon5 will be statistically non-inferior to that with the animal-derived Healon5 control using a non-inferiority margin of 5%.
Outcome measures
| Measure |
Investigational Healon5 OVD (Bacterially-Derived)
n=206 Participants
Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Investigational Healon5 OVD: ophthalmic viscosurgical device
|
Approved Healon5 OVD (Animal-Derived)
n=206 Participants
Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Healon5 OVD: ophthalmic viscosurgical device
|
|---|---|---|
|
Mean Percent Endothelial Cell Count (ECC) Change Preoperatively vs. Postoperatively
|
-5.55 percent change
Interval -6.92 to -4.17
|
-6.66 percent change
Interval -8.06 to -5.25
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: The results are consist of all subjects who had any study OVD used and with data available at the time of analysis.
Ocular serious and/or device related adverse event rates was be tabulated with the frequency and proportion of eyes with these events reported over time and cumulatively by OVD group. \* in the results table denotes SAEs determined to be device-related
Outcome measures
| Measure |
Investigational Healon5 OVD (Bacterially-Derived)
n=211 Eyes
Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Investigational Healon5 OVD: ophthalmic viscosurgical device
|
Approved Healon5 OVD (Animal-Derived)
n=210 Eyes
Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Healon5 OVD: ophthalmic viscosurgical device
|
|---|---|---|
|
Ocular Serious Adverse Events (SAE)
Conjunctival Laceration
|
0 Eyes
|
1 Eyes
|
|
Ocular Serious Adverse Events (SAE)
Cystoid macular edema
|
0 Eyes
|
1 Eyes
|
|
Ocular Serious Adverse Events (SAE)
Elevated IOP/IOP spike (30 mmHg or greater)*
|
18 Eyes
|
13 Eyes
|
|
Ocular Serious Adverse Events (SAE)
IOP spike <30 mmHg, requiring treatment*
|
0 Eyes
|
3 Eyes
|
|
Ocular Serious Adverse Events (SAE)
Keratitis secondary to Sjogren's
|
1 Eyes
|
0 Eyes
|
|
Ocular Serious Adverse Events (SAE)
Mild TASS
|
1 Eyes
|
1 Eyes
|
|
Ocular Serious Adverse Events (SAE)
Proliferative Diabetic Retinopathy
|
1 Eyes
|
0 Eyes
|
|
Ocular Serious Adverse Events (SAE)
Wound leak
|
0 Eyes
|
1 Eyes
|
|
Ocular Serious Adverse Events (SAE)
Mild inflammation secondary to gout
|
0 Eyes
|
1 Eyes
|
|
Ocular Serious Adverse Events (SAE)
Total eyes with no SAEs
|
190 Eyes
|
189 Eyes
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Results are based on paired-eye subjects included in the safety population.
The mean change in IOP from baseline for both OVD groups over time at the 6 hour, 1 day, 1 week, 1 month, and 3 month postoperative time points are presented.
Outcome measures
| Measure |
Investigational Healon5 OVD (Bacterially-Derived)
n=208 eyes
Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Investigational Healon5 OVD: ophthalmic viscosurgical device
|
Approved Healon5 OVD (Animal-Derived)
n=208 eyes
Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Healon5 OVD: ophthalmic viscosurgical device
|
|---|---|---|
|
Mean Change in IOP From Baseline
Change in IOP from Baseline (mmHg) at 6 hours
|
5.8 mmHg
Standard Deviation 6.9
|
5.2 mmHg
Standard Deviation 5.9
|
|
Mean Change in IOP From Baseline
Change in IOP from Baseline (mmHg) at 1 day
|
3.9 mmHg
Standard Deviation 7.0
|
3.6 mmHg
Standard Deviation 4.9
|
|
Mean Change in IOP From Baseline
Change in IOP from Baseline (mmHg) 1 week
|
0.7 mmHg
Standard Deviation 3.3
|
0.9 mmHg
Standard Deviation 3.5
|
|
Mean Change in IOP From Baseline
Change in IOP from Baseline (mmHg) 3 months
|
-1.4 mmHg
Standard Deviation 2.6
|
-1.3 mmHg
Standard Deviation 2.8
|
|
Mean Change in IOP From Baseline
Change in IOP from Baseline (mmHg) 1 month
|
-0.6 mmHg
Standard Deviation 2.8
|
-0.6 mmHg
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Results are based on paired-eye subjects included in the safety population.
The rate of IOP spike 30 mmHg or greater at 6 hour, 1 day, 1 week, 1 month and 3 months postoperatively was tabulated with frequency and proportion by OVD group.
Outcome measures
| Measure |
Investigational Healon5 OVD (Bacterially-Derived)
n=208 eyes
Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Investigational Healon5 OVD: ophthalmic viscosurgical device
|
Approved Healon5 OVD (Animal-Derived)
n=208 eyes
Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Healon5 OVD: ophthalmic viscosurgical device
|
|---|---|---|
|
Rate of IOP Spikes 30 mmHg or Greater at 3 Month Postoperatively
6 Hours
|
16 eyes
|
9 eyes
|
|
Rate of IOP Spikes 30 mmHg or Greater at 3 Month Postoperatively
1 Day
|
4 eyes
|
5 eyes
|
|
Rate of IOP Spikes 30 mmHg or Greater at 3 Month Postoperatively
1 Week
|
0 eyes
|
0 eyes
|
|
Rate of IOP Spikes 30 mmHg or Greater at 3 Month Postoperatively
1 Month
|
0 eyes
|
0 eyes
|
|
Rate of IOP Spikes 30 mmHg or Greater at 3 Month Postoperatively
3 Months
|
0 eyes
|
0 eyes
|
SECONDARY outcome
Timeframe: Upto 3 monthsPopulation: The safety population consists of all subjects who had any study OVD used and with data available at the time of analysis Number of eyes analyzed for Control OVD at 1 month and 3 months were less than the overall number analyzed because one subject was lost to follow up.
The grades of inflammation for epithelial edema was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.
Outcome measures
| Measure |
Investigational Healon5 OVD (Bacterially-Derived)
n=211 eyes
Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Investigational Healon5 OVD: ophthalmic viscosurgical device
|
Approved Healon5 OVD (Animal-Derived)
n=210 eyes
Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Healon5 OVD: ophthalmic viscosurgical device
|
|---|---|---|
|
Grade of Inflammation: Epithelial Edema
Epithelial Edema at 1 Month · None (0)
|
210 eyes
|
208 eyes
|
|
Grade of Inflammation: Epithelial Edema
Epithelial Edema at 1 Month · Trace (+1)
|
1 eyes
|
1 eyes
|
|
Grade of Inflammation: Epithelial Edema
Epithelial Edema at 3 Month · None (0)
|
211 eyes
|
209 eyes
|
|
Grade of Inflammation: Epithelial Edema
Epithelial Edema at 3 Month · Trace (+1)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Epithelial Edema
Epithelial Edema at 6 Hours · None (0)
|
144 eyes
|
141 eyes
|
|
Grade of Inflammation: Epithelial Edema
Epithelial Edema at 6 Hours · Trace (+1)
|
42 eyes
|
47 eyes
|
|
Grade of Inflammation: Epithelial Edema
Epithelial Edema at 6 Hours · Mild (+2)
|
20 eyes
|
17 eyes
|
|
Grade of Inflammation: Epithelial Edema
Epithelial Edema at 6 Hours · Moderate (+3)
|
5 eyes
|
5 eyes
|
|
Grade of Inflammation: Epithelial Edema
Epithelial Edema at 6 Hours · Severe (+4)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Epithelial Edema
Epithelial Edema at 1 Day · None (0)
|
173 eyes
|
175 eyes
|
|
Grade of Inflammation: Epithelial Edema
Epithelial Edema at 1 Day · Trace (+1)
|
24 eyes
|
21 eyes
|
|
Grade of Inflammation: Epithelial Edema
Epithelial Edema at 1 Day · Mild (+2)
|
10 eyes
|
11 eyes
|
|
Grade of Inflammation: Epithelial Edema
Epithelial Edema at 1 Day · Moderate (+3)
|
3 eyes
|
2 eyes
|
|
Grade of Inflammation: Epithelial Edema
Epithelial Edema at 1 Day · Severe (+4)
|
1 eyes
|
1 eyes
|
|
Grade of Inflammation: Epithelial Edema
Epithelial Edema at 1 Week · None (0)
|
200 eyes
|
203 eyes
|
|
Grade of Inflammation: Epithelial Edema
Epithelial Edema at 1 Week · Trace (+1)
|
11 eyes
|
5 eyes
|
|
Grade of Inflammation: Epithelial Edema
Epithelial Edema at 1 Week · Mild (+2)
|
0 eyes
|
2 eyes
|
|
Grade of Inflammation: Epithelial Edema
Epithelial Edema at 1 Week · Moderate (+3)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Epithelial Edema
Epithelial Edema at 1 Week · Severe (+4)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Epithelial Edema
Epithelial Edema at 1 Month · Mild (+2)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Epithelial Edema
Epithelial Edema at 1 Month · Moderate (+3)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Epithelial Edema
Epithelial Edema at 1 Month · Severe (+4)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Epithelial Edema
Epithelial Edema at 3 Month · Mild (+2)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Epithelial Edema
Epithelial Edema at 3 Month · Moderate (+3)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Epithelial Edema
Epithelial Edema at 3 Month · Severe (+4)
|
0 eyes
|
0 eyes
|
SECONDARY outcome
Timeframe: Upto 3 monthsPopulation: The safety population consists of all subjects who had any study OVD used and with data available at the time of analysis Number of eyes analyzed for Control OVD at 1 month and 3 months were less than overall number analyzed because one subject was lost to follow up.
The grades of inflammation for stromal edema was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.
Outcome measures
| Measure |
Investigational Healon5 OVD (Bacterially-Derived)
n=211 eyes
Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Investigational Healon5 OVD: ophthalmic viscosurgical device
|
Approved Healon5 OVD (Animal-Derived)
n=210 eyes
Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Healon5 OVD: ophthalmic viscosurgical device
|
|---|---|---|
|
Grade of Inflammation: Stromal Edema
Stromal Edema at 1 Day · Severe (+4)
|
0 eyes
|
1 eyes
|
|
Grade of Inflammation: Stromal Edema
Stromal Edema at 1 Week · None (0)
|
207 eyes
|
206 eyes
|
|
Grade of Inflammation: Stromal Edema
Stromal Edema at 1 Week · Trace (+1)
|
4 eyes
|
3 eyes
|
|
Grade of Inflammation: Stromal Edema
Stromal Edema at 1 Week · Mild (+2)
|
0 eyes
|
1 eyes
|
|
Grade of Inflammation: Stromal Edema
Stromal Edema at 1 Week · Moderate (+3)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Stromal Edema
Stromal Edema at 1 Month · Trace (+1)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Stromal Edema
Stromal Edema at 1 Month · Mild (+2)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Stromal Edema
Stromal Edema at 3 Months · Trace (+1)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Stromal Edema
Stromal Edema at 3 Months · Mild (+2)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Stromal Edema
Stromal Edema at 3 Months · Moderate (+3)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Stromal Edema
Stromal Edema at 6 Hours · None (0)
|
178 eyes
|
173 eyes
|
|
Grade of Inflammation: Stromal Edema
Stromal Edema at 6 Hours · Trace (+1)
|
27 eyes
|
30 eyes
|
|
Grade of Inflammation: Stromal Edema
Stromal Edema at 6 Hours · Mild (+2)
|
5 eyes
|
6 eyes
|
|
Grade of Inflammation: Stromal Edema
Stromal Edema at 6 Hours · Moderate (+3)
|
1 eyes
|
1 eyes
|
|
Grade of Inflammation: Stromal Edema
Stromal Edema at 6 Hours · Severe (+4)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Stromal Edema
Stromal Edema at 1 Day · None (0)
|
184 eyes
|
182 eyes
|
|
Grade of Inflammation: Stromal Edema
Stromal Edema at 1 Day · Trace (+1)
|
24 eyes
|
23 eyes
|
|
Grade of Inflammation: Stromal Edema
Stromal Edema at 1 Day · Mild (+2)
|
3 eyes
|
4 eyes
|
|
Grade of Inflammation: Stromal Edema
Stromal Edema at 1 Day · Moderate (+3)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Stromal Edema
Stromal Edema at 1 Week · Severe (+4)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Stromal Edema
Stromal Edema at 1 Month · None (0)
|
211 eyes
|
209 eyes
|
|
Grade of Inflammation: Stromal Edema
Stromal Edema at 1 Month · Moderate (+3)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Stromal Edema
Stromal Edema at 1 Month · Severe (+4)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Stromal Edema
Stromal Edema at 3 Months · None (0)
|
211 eyes
|
209 eyes
|
|
Grade of Inflammation: Stromal Edema
Stromal Edema at 3 Months · Severe (+4)
|
0 eyes
|
0 eyes
|
SECONDARY outcome
Timeframe: Upto 3 monthsPopulation: The safety population consists of all subjects who had any study OVD used and with data available at the time of analysis Number of eyes analyzed for Control OVD at 1 month and 3 months were less than the overall number analyzed because one subject was lost to follow up.
The grades of inflammation for cells was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.
Outcome measures
| Measure |
Investigational Healon5 OVD (Bacterially-Derived)
n=211 eyes
Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Investigational Healon5 OVD: ophthalmic viscosurgical device
|
Approved Healon5 OVD (Animal-Derived)
n=210 eyes
Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Healon5 OVD: ophthalmic viscosurgical device
|
|---|---|---|
|
Grade of Inflammation: Cells
Cells at 6 Hours · Mild (2+)
|
21 eyes
|
26 eyes
|
|
Grade of Inflammation: Cells
Cells at 6 Hours · Moderate (3+)
|
1 eyes
|
6 eyes
|
|
Grade of Inflammation: Cells
Cells at 6 Hours · Severe (4+)
|
1 eyes
|
0 eyes
|
|
Grade of Inflammation: Cells
Cells at 1 Day · Rare (0.5+)
|
29 eyes
|
38 eyes
|
|
Grade of Inflammation: Cells
Cells at 1 Day · Trace (1+)
|
123 eyes
|
121 eyes
|
|
Grade of Inflammation: Cells
Cells at 1 Day · Mild (2+)
|
9 eyes
|
14 eyes
|
|
Grade of Inflammation: Cells
Cells at 1 Day · Moderate (3+)
|
4 eyes
|
1 eyes
|
|
Grade of Inflammation: Cells
Cells at 1 Day · Severe (4+)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Cells
Cells at 1 Week · None (0)
|
119 eyes
|
134 eyes
|
|
Grade of Inflammation: Cells
Cells at 1 Week · Mild (2+)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Cells
Cells at 1 Week · Moderate (3+)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Cells
Cells at 1 Week · Severe (4+)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Cells
Cells at 1 Month · None (0)
|
196 eyes
|
193 eyes
|
|
Grade of Inflammation: Cells
Cells at 1 Month · Trace (1+)
|
1 eyes
|
0 eyes
|
|
Grade of Inflammation: Cells
Cells at 1 Month · Mild (2+)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Cells
Cells at 3 Months · Mild (2+)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Cells
Cells at 3 Months · Moderate (3+)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Cells
Cells at 6 Hours · None (0)
|
27 eyes
|
22 eyes
|
|
Grade of Inflammation: Cells
Cells at 6 Hours · Rare (0.5+)
|
45 eyes
|
51 eyes
|
|
Grade of Inflammation: Cells
Cells at 6 Hours · Trace (1+)
|
116 eyes
|
105 eyes
|
|
Grade of Inflammation: Cells
Cells at 1 Day · None (0)
|
46 eyes
|
36 eyes
|
|
Grade of Inflammation: Cells
Cells at 1 Week · Rare (0.5+)
|
87 eyes
|
72 eyes
|
|
Grade of Inflammation: Cells
Cells at 1 Week · Trace (1+)
|
5 eyes
|
4 eyes
|
|
Grade of Inflammation: Cells
Cells at 1 Month · Rare (0.5+)
|
14 eyes
|
16 eyes
|
|
Grade of Inflammation: Cells
Cells at 1 Month · Moderate (3+)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Cells
Cells at 1 Month · Severe (4+)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Cells
Cells at 3 Months · None (0)
|
207 eyes
|
206 eyes
|
|
Grade of Inflammation: Cells
Cells at 3 Months · Rare (0.5+)
|
4 eyes
|
3 eyes
|
|
Grade of Inflammation: Cells
Cells at 3 Months · Trace (1+)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Cells
Cells at 3 Months · Severe (4+)
|
0 eyes
|
0 eyes
|
SECONDARY outcome
Timeframe: Upto 3 monthsPopulation: The safety population consists of all subjects who had any study OVD used and with data available at the time of analysis Number of eyes analyzed for Control OVD at 1 month and 3 months were less than the overall number analyzed because one subject was lost to follow up.
The grades of inflammation for flare was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.
Outcome measures
| Measure |
Investigational Healon5 OVD (Bacterially-Derived)
n=211 eyes
Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Investigational Healon5 OVD: ophthalmic viscosurgical device
|
Approved Healon5 OVD (Animal-Derived)
n=210 eyes
Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Healon5 OVD: ophthalmic viscosurgical device
|
|---|---|---|
|
Grade of Inflammation: Flare
Flares at 6 Hours · Moderate (2+)
|
0 eyes
|
7 eyes
|
|
Grade of Inflammation: Flare
Flares at 1 Day · None (0)
|
145 eyes
|
154 eyes
|
|
Grade of Inflammation: Flare
Flares at 6 Hours · None (0)
|
118 eyes
|
112 eyes
|
|
Grade of Inflammation: Flare
Flares at 6 Hours · Faint/Trace/Mild (1+)
|
93 eyes
|
91 eyes
|
|
Grade of Inflammation: Flare
Flares at 1 Day · Faint/Trace/Mild (1+)
|
64 eyes
|
55 eyes
|
|
Grade of Inflammation: Flare
Flares at 1 Day · Moderate (2+)
|
2 eyes
|
1 eyes
|
|
Grade of Inflammation: Flare
Flares at 1 Week · None (0)
|
204 eyes
|
206 eyes
|
|
Grade of Inflammation: Flare
Flares at 1 Week · Faint/Trace/Mild (1+)
|
7 eyes
|
4 eyes
|
|
Grade of Inflammation: Flare
Flares at 1 Week · Moderate (2+)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Flare
Flares at 1 Month · None (0)
|
210 eyes
|
209 eyes
|
|
Grade of Inflammation: Flare
Flares at 1 Month · Faint/Trace/Mild (1+)
|
1 eyes
|
0 eyes
|
|
Grade of Inflammation: Flare
Flares at 1 Month · Moderate (2+)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Flare
Flares at 6 Months · None (0)
|
211 eyes
|
208 eyes
|
|
Grade of Inflammation: Flare
Flares at 6 Months · Faint/Trace/Mild (1+)
|
0 eyes
|
1 eyes
|
|
Grade of Inflammation: Flare
Flares at 6 Months · Moderate (2+)
|
0 eyes
|
0 eyes
|
SECONDARY outcome
Timeframe: Upto 3 monthsPopulation: The safety population consists of all subjects who had any study OVD used and with data available at the time of analysis Number of eyes analyzed for Control OVD at 1 month and 3 months were less than the overall number analyzed because one subject was lost to follow up.
The grades of inflammation for Anterior Synechiae was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.
Outcome measures
| Measure |
Investigational Healon5 OVD (Bacterially-Derived)
n=211 eyes
Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Investigational Healon5 OVD: ophthalmic viscosurgical device
|
Approved Healon5 OVD (Animal-Derived)
n=210 eyes
Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Healon5 OVD: ophthalmic viscosurgical device
|
|---|---|---|
|
Grade of Inflammation: Anterior Synechiae
Anterior Synechiae at 6 Hours · Trace (+1)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Anterior Synechiae
Anterior Synechiae at 6 Hours · Mild (+2)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Anterior Synechiae
Anterior Synechiae at 1 Month · None (0)
|
211 eyes
|
209 eyes
|
|
Grade of Inflammation: Anterior Synechiae
Anterior Synechiae at 1 Month · Trace (+1)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Anterior Synechiae
Anterior Synechiae at 1 Month · Mild (+2)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Anterior Synechiae
Anterior Synechiae at 3 Months · None (0)
|
211 eyes
|
209 eyes
|
|
Grade of Inflammation: Anterior Synechiae
Anterior Synechiae at 3 Months · Trace (+1)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Anterior Synechiae
Anterior Synechiae at 3 Months · Mild (+2)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Anterior Synechiae
Anterior Synechiae at 6 Hours · None (0)
|
211 eyes
|
210 eyes
|
|
Grade of Inflammation: Anterior Synechiae
Anterior Synechiae at 1 Day · None (0)
|
211 eyes
|
209 eyes
|
|
Grade of Inflammation: Anterior Synechiae
Anterior Synechiae at 1 Day · Trace (+1)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Anterior Synechiae
Anterior Synechiae at 1 Day · Mild (+2)
|
0 eyes
|
1 eyes
|
|
Grade of Inflammation: Anterior Synechiae
Anterior Synechiae at 1 Week · None (0)
|
210 eyes
|
210 eyes
|
|
Grade of Inflammation: Anterior Synechiae
Anterior Synechiae at 1 Week · Trace (+1)
|
1 eyes
|
0 eyes
|
|
Grade of Inflammation: Anterior Synechiae
Anterior Synechiae at 1 Week · Mild (+2)
|
0 eyes
|
0 eyes
|
SECONDARY outcome
Timeframe: Upto 3 MonthsPopulation: The safety population consists of all subjects who had any study OVD used and with data available at the time of analysis Number of eyes analyzed for Control OVD at 1 month and 3 months were less than the overall number analyzed because one subject was lost to follow up.
The grades of inflammation for Posterior Synechiae was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.
Outcome measures
| Measure |
Investigational Healon5 OVD (Bacterially-Derived)
n=211 eyes
Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Investigational Healon5 OVD: ophthalmic viscosurgical device
|
Approved Healon5 OVD (Animal-Derived)
n=210 eyes
Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Healon5 OVD: ophthalmic viscosurgical device
|
|---|---|---|
|
Grade of Inflammation: Posterior Synechiae
Posterior Synechiae at 6 Hours · None (0)
|
210 eyes
|
210 eyes
|
|
Grade of Inflammation: Posterior Synechiae
Posterior Synechiae at 6 Hours · Trace (+1)
|
1 eyes
|
0 eyes
|
|
Grade of Inflammation: Posterior Synechiae
Posterior Synechiae at 1 Day · None (0)
|
211 eyes
|
210 eyes
|
|
Grade of Inflammation: Posterior Synechiae
Posterior Synechiae at 1 Month · Trace (+1)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Posterior Synechiae
Posterior Synechiae 3 Months · None (0)
|
211 eyes
|
209 eyes
|
|
Grade of Inflammation: Posterior Synechiae
Posterior Synechiae 3 Months · Trace (+1)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Posterior Synechiae
Posterior Synechiae at 1 Day · Trace (+1)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Posterior Synechiae
Posterior Synechiae at 1 Week · None (0)
|
211 eyes
|
210 eyes
|
|
Grade of Inflammation: Posterior Synechiae
Posterior Synechiae at 1 Week · Trace (+1)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Posterior Synechiae
Posterior Synechiae at 1 Month · None (0)
|
211 eyes
|
209 eyes
|
SECONDARY outcome
Timeframe: Upto 3 MonthsPopulation: The safety population consists of all subjects who had any study OVD used and with data available at the time of analysis Number of eyes analyzed for Control OVD at 1 month and 3 months were less than the overall number analyzed because one subject was lost to follow up.
The grades of inflammation for Fibrin Presence was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.
Outcome measures
| Measure |
Investigational Healon5 OVD (Bacterially-Derived)
n=211 eyes
Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Investigational Healon5 OVD: ophthalmic viscosurgical device
|
Approved Healon5 OVD (Animal-Derived)
n=210 eyes
Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Healon5 OVD: ophthalmic viscosurgical device
|
|---|---|---|
|
Grade of Inflammation: Fibrin Presence
Fibrin Presence at 6 Hours · None (0)
|
210 eyes
|
210 eyes
|
|
Grade of Inflammation: Fibrin Presence
Fibrin Presence at 6 Hours · Trace (+1)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Fibrin Presence
Fibrin Presence at 1 Week · None (0)
|
211 eyes
|
210 eyes
|
|
Grade of Inflammation: Fibrin Presence
Fibrin Presence at 1 Week · Trace (+1)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Fibrin Presence
Fibrin Presence at 6 Hours · Mild (+2)
|
1 eyes
|
0 eyes
|
|
Grade of Inflammation: Fibrin Presence
Fibrin Presence at 1 Day · None (0)
|
210 eyes
|
209 eyes
|
|
Grade of Inflammation: Fibrin Presence
Fibrin Presence at 1 Day · Trace (+1)
|
1 eyes
|
1 eyes
|
|
Grade of Inflammation: Fibrin Presence
Fibrin Presence at 1 Day · Mild (+2)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Fibrin Presence
Fibrin Presence at 1 Week · Mild (+2)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Fibrin Presence
Fibrin Presence at 1 Month · None (0)
|
210 eyes
|
209 eyes
|
|
Grade of Inflammation: Fibrin Presence
Fibrin Presence at 1 Month · Trace (+1)
|
1 eyes
|
0 eyes
|
|
Grade of Inflammation: Fibrin Presence
Fibrin Presence at 1 Month · Mild (+2)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Fibrin Presence
Fibrin Presence at 3 Months · None (0)
|
211 eyes
|
209 eyes
|
|
Grade of Inflammation: Fibrin Presence
Fibrin Presence at 3 Months · Trace (+1)
|
0 eyes
|
0 eyes
|
|
Grade of Inflammation: Fibrin Presence
Fibrin Presence at 3 Months · Mild (+2)
|
0 eyes
|
0 eyes
|
Adverse Events
Investigational Healon5 OVD
Serious events: 24 serious events
Other events: 174 other events
Deaths: 0 deaths
Approved Healon5 OVD
Serious events: 24 serious events
Other events: 173 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Investigational Healon5 OVD
n=211 participants at risk
Subjects to receive investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Investigational Healon5 OVD: ophthalmic viscosurgical device
|
Approved Healon5 OVD
n=210 participants at risk
Subjects to receive investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Healon5 OVD: ophthalmic viscosurgical device
|
|---|---|---|
|
Eye disorders
Elevated IOP/IOP Spike (30 mmHg or greater)
|
8.5%
18/211 • 3 months
|
6.2%
13/210 • 3 months
|
|
Eye disorders
IOP spike <30 mmHg, requiring treatment
|
0.00%
0/211 • 3 months
|
1.4%
3/210 • 3 months
|
|
Eye disorders
Conjunctival Laceration
|
0.00%
0/211 • 3 months
|
0.48%
1/210 • 3 months
|
|
Eye disorders
Cystoid macular edema
|
0.00%
0/211 • 3 months
|
0.48%
1/210 • 3 months
|
|
Eye disorders
Keratitis secondary to Sjogren's
|
0.47%
1/211 • 3 months
|
0.00%
0/210 • 3 months
|
|
Eye disorders
Mild TASS (toxic anterior segment syndrome)
|
0.47%
1/211 • 3 months
|
0.48%
1/210 • 3 months
|
|
Eye disorders
Proliferative Diabetic Retinopathy
|
0.47%
1/211 • 3 months
|
0.00%
0/210 • 3 months
|
|
Eye disorders
wound leak
|
0.00%
0/211 • 3 months
|
0.48%
1/210 • 3 months
|
|
Eye disorders
Mild inflammation secondary to gout
|
0.00%
0/211 • 3 months
|
0.48%
1/210 • 3 months
|
|
Vascular disorders
Hospitalization: tests and observation of possible transient ischemic attack and dementia
|
0.47%
1/211 • 3 months
|
0.48%
1/210 • 3 months
|
|
Skin and subcutaneous tissue disorders
Melanoma
|
0.47%
1/211 • 3 months
|
0.48%
1/210 • 3 months
|
|
Immune system disorders
Hospitalization: penumonia and flu
|
0.47%
1/211 • 3 months
|
0.48%
1/210 • 3 months
|
Other adverse events
| Measure |
Investigational Healon5 OVD
n=211 participants at risk
Subjects to receive investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Investigational Healon5 OVD: ophthalmic viscosurgical device
|
Approved Healon5 OVD
n=210 participants at risk
Subjects to receive investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Healon5 OVD: ophthalmic viscosurgical device
|
|---|---|---|
|
Eye disorders
Posterior capsule opacification
|
35.1%
74/211 • 3 months
|
37.1%
78/210 • 3 months
|
|
Eye disorders
Blepharitis/meibomiantis
|
21.8%
46/211 • 3 months
|
21.4%
45/210 • 3 months
|
|
Eye disorders
dry eye/superficial punctate keratopathy/punctate epithelialerosion/tear film insufficiency
|
43.6%
92/211 • 3 months
|
43.3%
91/210 • 3 months
|
|
Eye disorders
Posterior vitreous detachment
|
19.9%
42/211 • 3 months
|
18.1%
38/210 • 3 months
|
|
Eye disorders
Elevated IOP/ocular hypertension
|
8.1%
17/211 • 3 months
|
8.1%
17/210 • 3 months
|
|
Eye disorders
Posterior capsule striae/wrinkles
|
24.6%
52/211 • 3 months
|
24.8%
52/210 • 3 months
|
|
Eye disorders
Drusen
|
7.6%
16/211 • 3 months
|
8.1%
17/210 • 3 months
|
|
Eye disorders
Dermatochalasis
|
7.1%
15/211 • 3 months
|
8.1%
17/210 • 3 months
|
|
Eye disorders
Folds in Descemet's
|
24.2%
51/211 • 3 months
|
27.1%
57/210 • 3 months
|
Additional Information
Kendra Hileman, Ph.D., Head of Clinical Sciences
Abbott Medical Optics, Inc.
Phone: 714-247-8613
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results.
- Publication restrictions are in place
Restriction type: OTHER