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Clinical Investigation of the Bacterially-Derived Healon5 Ophthalmic Viscosurgical Device (OVD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02782676
Recruitment Status : Completed
First Posted : May 25, 2016
Results First Posted : May 24, 2018
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cataract
Interventions Device: Investigational Healon5 OVD
Device: Healon5 OVD
Enrollment 241
Recruitment Details  
Pre-assignment Details

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.

Arm/Group Title Investigational Healon5 OVD (Bacterially-Derived) Approved Healon5 OVD (Animal-Derived)
Hide Arm/Group Description

Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.

Investigational Healon5 OVD: ophthalmic viscosurgical device

Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.

Healon5 OVD: ophthalmic viscosurgical device

Period Title: Overall Study
Number of participants Number of units (Eyes) Number of participants Number of units (Eyes)
Started 211 211 210 210
Completed 211 211 209 209
Not Completed 0 0 1 1
Reason Not Completed
Lost to Follow-up             0                         1            
Arm/Group Title Subjects Received OVD (Bacterial and/or Animal-Derived)
Hide Arm/Group Description

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)

Overall Number of Baseline Participants 213
Hide Baseline Analysis Population Description
208 participants received both products, while 3 only received the Bacterially-Derived OVD and 2 only received the Animal-Derived OVD for a total of 213 paired-eye and non-paired eye subjects.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 213 participants
68.7  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 213 participants
Female
124
  58.2%
Male
89
  41.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 213 participants
American Indian or Alaska Native
1
   0.5%
Asian
5
   2.3%
Native Hawaiian or Other Pacific Islander
1
   0.5%
Black or African American
5
   2.3%
White
200
  93.9%
More than one race
0
   0.0%
Unknown or Not Reported
1
   0.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 213 participants
213
 100.0%
1.Primary Outcome
Title Cumulative Rates of Intraocular Pressure (IOP) Spikes 30mm of Mercury (mmHg) or Greater Measured Postoperatively
Hide Description 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%.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Investigational Healon5 OVD (Bacterially-Derived) Approved Healon5 OVD (Animal-Derived)
Hide Arm/Group Description:

Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.

Investigational Healon5 OVD: ophthalmic viscosurgical device

Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.

Healon5 OVD: ophthalmic viscosurgical device

Overall Number of Participants Analyzed 208 208
Measure Type: Count of Participants
Unit of Measure: Participants
17
   8.2%
13
   6.3%
2.Primary Outcome
Title Mean Percent Endothelial Cell Count (ECC) Change Preoperatively vs. Postoperatively
Hide Description 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%.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Investigational Healon5 OVD (Bacterially-Derived) Approved Healon5 OVD (Animal-Derived)
Hide Arm/Group Description:

Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.

Investigational Healon5 OVD: ophthalmic viscosurgical device

Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.

Healon5 OVD: ophthalmic viscosurgical device

Overall Number of Participants Analyzed 206 206
Mean (95% Confidence Interval)
Unit of Measure: percent change
-5.55
(-6.92 to -4.17)
-6.66
(-8.06 to -5.25)
3.Secondary Outcome
Title Ocular Serious Adverse Events (SAE)
Hide Description

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

Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
The results are consist of all subjects who had any study OVD used and with data available at the time of analysis.
Arm/Group Title Investigational Healon5 OVD (Bacterially-Derived) Approved Healon5 OVD (Animal-Derived)
Hide Arm/Group Description:

Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.

Investigational Healon5 OVD: ophthalmic viscosurgical device

Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.

Healon5 OVD: ophthalmic viscosurgical device

Overall Number of Participants Analyzed 211 210
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
211 210
Count of Units
Unit of Measure: Eyes
Conjunctival Laceration
0
   0.0%
1
   0.5%
Cystoid macular edema
0
   0.0%
1
   0.5%
Elevated IOP/IOP spike (30 mmHg or greater)*
18
   8.5%
13
   6.2%
IOP spike <30 mmHg, requiring treatment*
0
   0.0%
3
   1.4%
Keratitis secondary to Sjogren's
1
   0.5%
0
   0.0%
Mild TASS
1
   0.5%
1
   0.5%
Proliferative Diabetic Retinopathy
1
   0.5%
0
   0.0%
Wound leak
0
   0.0%
1
   0.5%
Mild inflammation secondary to gout
0
   0.0%
1
   0.5%
Total eyes with no SAEs
190
  90.0%
189
  90.0%
4.Secondary Outcome
Title Mean Change in IOP From Baseline
Hide Description 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.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on paired-eye subjects included in the safety population.
Arm/Group Title Investigational Healon5 OVD (Bacterially-Derived) Approved Healon5 OVD (Animal-Derived)
Hide Arm/Group Description:

Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.

Investigational Healon5 OVD: ophthalmic viscosurgical device

Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.

Healon5 OVD: ophthalmic viscosurgical device

Overall Number of Participants Analyzed 208 208
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
208 208
Mean (Standard Deviation)
Unit of Measure: mmHg
Change in IOP from Baseline (mmHg) at 6 hours 5.8  (6.9) 5.2  (5.9)
Change in IOP from Baseline (mmHg) at 1 day 3.9  (7.0) 3.6  (4.9)
Change in IOP from Baseline (mmHg) 1 week 0.7  (3.3) 0.9  (3.5)
Change in IOP from Baseline (mmHg) 1 month -0.6  (2.8) -0.6  (2.8)
Change in IOP from Baseline (mmHg) 3 months -1.4  (2.6) -1.3  (2.8)
5.Secondary Outcome
Title Rate of IOP Spikes 30 mmHg or Greater at 3 Month Postoperatively
Hide Description 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.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on paired-eye subjects included in the safety population.
Arm/Group Title Investigational Healon5 OVD (Bacterially-Derived) Approved Healon5 OVD (Animal-Derived)
Hide Arm/Group Description:

Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.

Investigational Healon5 OVD: ophthalmic viscosurgical device

Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.

Healon5 OVD: ophthalmic viscosurgical device

Overall Number of Participants Analyzed 208 208
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
208 208
Count of Units
Unit of Measure: eyes
6 Hours
16
   7.7%
9
   4.3%
1 Day
4
   1.9%
5
   2.4%
1 Week
0
   0.0%
0
   0.0%
1 Month
0
   0.0%
0
   0.0%
3 Months
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Grade of Inflammation: Epithelial Edema
Hide Description 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.
Time Frame Upto 3 months
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Investigational Healon5 OVD (Bacterially-Derived) Approved Healon5 OVD (Animal-Derived)
Hide Arm/Group Description:

Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.

Investigational Healon5 OVD: ophthalmic viscosurgical device

Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.

Healon5 OVD: ophthalmic viscosurgical device

Overall Number of Participants Analyzed 211 210
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
211 210
Count of Units
Unit of Measure: eyes
Epithelial Edema at 6 Hours Number Analyzed 211 eyes 210 eyes
None (0)
144
  68.2%
141
  67.1%
Trace (+1)
42
  19.9%
47
  22.4%
Mild (+2)
20
   9.5%
17
   8.1%
Moderate (+3)
5
   2.4%
5
   2.4%
Severe (+4)
0
   0.0%
0
   0.0%
Epithelial Edema at 1 Day Number Analyzed 211 eyes 210 eyes
None (0)
173
  82.0%
175
  83.3%
Trace (+1)
24
  11.4%
21
  10.0%
Mild (+2)
10
   4.7%
11
   5.2%
Moderate (+3)
3
   1.4%
2
   1.0%
Severe (+4)
1
   0.5%
1
   0.5%
Epithelial Edema at 1 Week Number Analyzed 211 eyes 210 eyes
None (0)
200
  94.8%
203
  96.7%
Trace (+1)
11
   5.2%
5
   2.4%
Mild (+2)
0
   0.0%
2
   1.0%
Moderate (+3)
0
   0.0%
0
   0.0%
Severe (+4)
0
   0.0%
0
   0.0%
Epithelial Edema at 1 Month Number Analyzed 211 eyes 209 eyes [1] 
None (0)
210
  99.5%
208
  99.5%
Trace (+1)
1
   0.5%
1
   0.5%
Mild (+2)
0
   0.0%
0
   0.0%
Moderate (+3)
0
   0.0%
0
   0.0%
Severe (+4)
0
   0.0%
0
   0.0%
Epithelial Edema at 3 Month Number Analyzed 211 eyes 209 eyes [1] 
None (0)
211
 100.0%
209
 100.0%
Trace (+1)
0
   0.0%
0
   0.0%
Mild (+2)
0
   0.0%
0
   0.0%
Moderate (+3)
0
   0.0%
0
   0.0%
Severe (+4)
0
   0.0%
0
   0.0%
[1]
209 participants
7.Secondary Outcome
Title Grade of Inflammation: Stromal Edema
Hide Description 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.
Time Frame Upto 3 months
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Investigational Healon5 OVD (Bacterially-Derived) Approved Healon5 OVD (Animal-Derived)
Hide Arm/Group Description:

Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.

Investigational Healon5 OVD: ophthalmic viscosurgical device

Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.

Healon5 OVD: ophthalmic viscosurgical device

Overall Number of Participants Analyzed 211 210
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
211 210
Count of Units
Unit of Measure: eyes
Stromal Edema at 6 Hours Number Analyzed 211 eyes 210 eyes
None (0)
178
  84.4%
173
  82.4%
Trace (+1)
27
  12.8%
30
  14.3%
Mild (+2)
5
   2.4%
6
   2.9%
Moderate (+3)
1
   0.5%
1
   0.5%
Severe (+4)
0
   0.0%
0
   0.0%
Stromal Edema at 1 Day Number Analyzed 211 eyes 210 eyes
None (0)
184
  87.2%
182
  86.7%
Trace (+1)
24
  11.4%
23
  11.0%
Mild (+2)
3
   1.4%
4
   1.9%
Moderate (+3)
0
   0.0%
0
   0.0%
Severe (+4)
0
   0.0%
1
   0.5%
Stromal Edema at 1 Week Number Analyzed 211 eyes 210 eyes
None (0)
207
  98.1%
206
  98.1%
Trace (+1)
4
   1.9%
3
   1.4%
Mild (+2)
0
   0.0%
1
   0.5%
Moderate (+3)
0
   0.0%
0
   0.0%
Severe (+4)
0
   0.0%
0
   0.0%
Stromal Edema at 1 Month Number Analyzed 211 eyes 209 eyes [1] 
None (0)
211
 100.0%
209
 100.0%
Trace (+1)
0
   0.0%
0
   0.0%
Mild (+2)
0
   0.0%
0
   0.0%
Moderate (+3)
0
   0.0%
0
   0.0%
Severe (+4)
0
   0.0%
0
   0.0%
Stromal Edema at 3 Months Number Analyzed 211 eyes 209 eyes [1] 
None (0)
211
 100.0%
209
 100.0%
Trace (+1)
0
   0.0%
0
   0.0%
Mild (+2)
0
   0.0%
0
   0.0%
Moderate (+3)
0
   0.0%
0
   0.0%
Severe (+4)
0
   0.0%
0
   0.0%
[1]
209 participants
8.Secondary Outcome
Title Grade of Inflammation: Cells
Hide Description The grades of inflammation for cells was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.
Time Frame Upto 3 months
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Investigational Healon5 OVD (Bacterially-Derived) Approved Healon5 OVD (Animal-Derived)
Hide Arm/Group Description:

Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.

Investigational Healon5 OVD: ophthalmic viscosurgical device

Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.

Healon5 OVD: ophthalmic viscosurgical device

Overall Number of Participants Analyzed 211 210
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
211 210
Count of Units
Unit of Measure: eyes
Cells at 6 Hours Number Analyzed 211 eyes 210 eyes
None (0)
27
  12.8%
22
  10.5%
Rare (0.5+)
45
  21.3%
51
  24.3%
Trace (1+)
116
  55.0%
105
  50.0%
Mild (2+)
21
  10.0%
26
  12.4%
Moderate (3+)
1
   0.5%
6
   2.9%
Severe (4+)
1
   0.5%
0
   0.0%
Cells at 1 Day Number Analyzed 211 eyes 210 eyes
None (0)
46
  21.8%
36
  17.1%
Rare (0.5+)
29
  13.7%
38
  18.1%
Trace (1+)
123
  58.3%
121
  57.6%
Mild (2+)
9
   4.3%
14
   6.7%
Moderate (3+)
4
   1.9%
1
   0.5%
Severe (4+)
0
   0.0%
0
   0.0%
Cells at 1 Week Number Analyzed 211 eyes 210 eyes
None (0)
119
  56.4%
134
  63.8%
Rare (0.5+)
87
  41.2%
72
  34.3%
Trace (1+)
5
   2.4%
4
   1.9%
Mild (2+)
0
   0.0%
0
   0.0%
Moderate (3+)
0
   0.0%
0
   0.0%
Severe (4+)
0
   0.0%
0
   0.0%
Cells at 1 Month Number Analyzed 211 eyes 209 eyes [1] 
None (0)
196
  92.9%
193
  92.3%
Rare (0.5+)
14
   6.6%
16
   7.7%
Trace (1+)
1
   0.5%
0
   0.0%
Mild (2+)
0
   0.0%
0
   0.0%
Moderate (3+)
0
   0.0%
0
   0.0%
Severe (4+)
0
   0.0%
0
   0.0%
Cells at 3 Months Number Analyzed 211 eyes 209 eyes [1] 
None (0)
207
  98.1%
206
  98.6%
Rare (0.5+)
4
   1.9%
3
   1.4%
Trace (1+)
0
   0.0%
0
   0.0%
Mild (2+)
0
   0.0%
0
   0.0%
Moderate (3+)
0
   0.0%
0
   0.0%
Severe (4+)
0
   0.0%
0
   0.0%
[1]
209 participants
9.Secondary Outcome
Title Grade of Inflammation: Flare
Hide Description The grades of inflammation for flare was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.
Time Frame Upto 3 months
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Investigational Healon5 OVD (Bacterially-Derived) Approved Healon5 OVD (Animal-Derived)
Hide Arm/Group Description:

Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.

Investigational Healon5 OVD: ophthalmic viscosurgical device

Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.

Healon5 OVD: ophthalmic viscosurgical device

Overall Number of Participants Analyzed 211 210
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
211 210
Count of Units
Unit of Measure: eyes
Flares at 6 Hours Number Analyzed 211 eyes 210 eyes
None (0)
118
  55.9%
112
  53.3%
Faint/Trace/Mild (1+)
93
  44.1%
91
  43.3%
Moderate (2+)
0
   0.0%
7
   3.3%
Flares at 1 Day Number Analyzed 211 eyes 210 eyes
None (0)
145
  68.7%
154
  73.3%
Faint/Trace/Mild (1+)
64
  30.3%
55
  26.2%
Moderate (2+)
2
   0.9%
1
   0.5%
Flares at 1 Week Number Analyzed 211 eyes 210 eyes
None (0)
204
  96.7%
206
  98.1%
Faint/Trace/Mild (1+)
7
   3.3%
4
   1.9%
Moderate (2+)
0
   0.0%
0
   0.0%
Flares at 1 Month Number Analyzed 211 eyes 209 eyes [1] 
None (0)
210
  99.5%
209
 100.0%
Faint/Trace/Mild (1+)
1
   0.5%
0
   0.0%
Moderate (2+)
0
   0.0%
0
   0.0%
Flares at 6 Months Number Analyzed 211 eyes 209 eyes [1] 
None (0)
211
 100.0%
208
  99.5%
Faint/Trace/Mild (1+)
0
   0.0%
1
   0.5%
Moderate (2+)
0
   0.0%
0
   0.0%
[1]
209 participants
10.Secondary Outcome
Title Grade of Inflammation: Anterior Synechiae
Hide Description 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.
Time Frame Upto 3 months
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Investigational Healon5 OVD (Bacterially-Derived) Approved Healon5 OVD (Animal-Derived)
Hide Arm/Group Description:

Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.

Investigational Healon5 OVD: ophthalmic viscosurgical device

Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.

Healon5 OVD: ophthalmic viscosurgical device

Overall Number of Participants Analyzed 211 210
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
211 210
Count of Units
Unit of Measure: eyes
Anterior Synechiae at 6 Hours Number Analyzed 211 eyes 210 eyes
None (0)
211
 100.0%
210
 100.0%
Trace (+1)
0
   0.0%
0
   0.0%
Mild (+2)
0
   0.0%
0
   0.0%
Anterior Synechiae at 1 Day Number Analyzed 211 eyes 210 eyes
None (0)
211
 100.0%
209
  99.5%
Trace (+1)
0
   0.0%
0
   0.0%
Mild (+2)
0
   0.0%
1
   0.5%
Anterior Synechiae at 1 Week Number Analyzed 211 eyes 210 eyes
None (0)
210
  99.5%
210
 100.0%
Trace (+1)
1
   0.5%
0
   0.0%
Mild (+2)
0
   0.0%
0
   0.0%
Anterior Synechiae at 1 Month Number Analyzed 211 eyes 209 eyes [1] 
None (0)
211
 100.0%
209
 100.0%
Trace (+1)
0
   0.0%
0
   0.0%
Mild (+2)
0
   0.0%
0
   0.0%
Anterior Synechiae at 3 Months Number Analyzed 211 eyes 209 eyes [1] 
None (0)
211
 100.0%
209
 100.0%
Trace (+1)
0
   0.0%
0
   0.0%
Mild (+2)
0
   0.0%
0
   0.0%
[1]
209 participants
11.Secondary Outcome
Title Grade of Inflammation: Posterior Synechiae
Hide Description 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.
Time Frame Upto 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Investigational Healon5 OVD (Bacterially-Derived) Approved Healon5 OVD (Animal-Derived)
Hide Arm/Group Description:

Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.

Investigational Healon5 OVD: ophthalmic viscosurgical device

Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.

Healon5 OVD: ophthalmic viscosurgical device

Overall Number of Participants Analyzed 211 210
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
211 210
Count of Units
Unit of Measure: eyes
Posterior Synechiae at 6 Hours Number Analyzed 211 eyes 210 eyes
None (0)
210
  99.5%
210
 100.0%
Trace (+1)
1
   0.5%
0
   0.0%
Posterior Synechiae at 1 Day Number Analyzed 211 eyes 210 eyes
None (0)
211
 100.0%
210
 100.0%
Trace (+1)
0
   0.0%
0
   0.0%
Posterior Synechiae at 1 Week Number Analyzed 211 eyes 210 eyes
None (0)
211
 100.0%
210
 100.0%
Trace (+1)
0
   0.0%
0
   0.0%
Posterior Synechiae at 1 Month Number Analyzed 211 eyes 209 eyes [1] 
None (0)
211
 100.0%
209
 100.0%
Trace (+1)
0
   0.0%
0
   0.0%
Posterior Synechiae 3 Months Number Analyzed 211 eyes 209 eyes [1] 
None (0)
211
 100.0%
209
 100.0%
Trace (+1)
0
   0.0%
0
   0.0%
[1]
209 participants
12.Secondary Outcome
Title Grade of Inflammation: Fibrin Presence
Hide Description 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.
Time Frame Upto 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Investigational Healon5 OVD (Bacterially-Derived) Approved Healon5 OVD (Animal-Derived)
Hide Arm/Group Description:

Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.

Investigational Healon5 OVD: ophthalmic viscosurgical device

Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.

Healon5 OVD: ophthalmic viscosurgical device

Overall Number of Participants Analyzed 211 210
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
211 210
Count of Units
Unit of Measure: eyes
Fibrin Presence at 6 Hours Number Analyzed 211 eyes 210 eyes
None (0)
210
  99.5%
210
 100.0%
Trace (+1)
0
   0.0%
0
   0.0%
Mild (+2)
1
   0.5%
0
   0.0%
Fibrin Presence at 1 Day Number Analyzed 211 eyes 210 eyes
None (0)
210
  99.5%
209
  99.5%
Trace (+1)
1
   0.5%
1
   0.5%
Mild (+2)
0
   0.0%
0
   0.0%
Fibrin Presence at 1 Week Number Analyzed 211 eyes 210 eyes
None (0)
211
 100.0%
210
 100.0%
Trace (+1)
0
   0.0%
0
   0.0%
Mild (+2)
0
   0.0%
0
   0.0%
Fibrin Presence at 1 Month Number Analyzed 211 eyes 209 eyes [1] 
None (0)
210
  99.5%
209
 100.0%
Trace (+1)
1
   0.5%
0
   0.0%
Mild (+2)
0
   0.0%
0
   0.0%
Fibrin Presence at 3 Months Number Analyzed 211 eyes 209 eyes [1] 
None (0)
211
 100.0%
209
 100.0%
Trace (+1)
0
   0.0%
0
   0.0%
Mild (+2)
0
   0.0%
0
   0.0%
[1]
209 participants
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Investigational Healon5 OVD Approved Healon5 OVD
Hide Arm/Group Description

Subjects to receive investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.

Investigational Healon5 OVD: ophthalmic viscosurgical device

Subjects to receive investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.

Healon5 OVD: ophthalmic viscosurgical device

All-Cause Mortality
Investigational Healon5 OVD Approved Healon5 OVD
Affected / at Risk (%) Affected / at Risk (%)
Total   0/211 (0.00%)   0/210 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Investigational Healon5 OVD Approved Healon5 OVD
Affected / at Risk (%) Affected / at Risk (%)
Total   24/211 (11.37%)   24/210 (11.43%) 
Eye disorders     
Elevated IOP/IOP Spike (30 mmHg or greater)   18/211 (8.53%)  13/210 (6.19%) 
IOP spike <30 mmHg, requiring treatment   0/211 (0.00%)  3/210 (1.43%) 
Conjunctival Laceration   0/211 (0.00%)  1/210 (0.48%) 
Cystoid macular edema   0/211 (0.00%)  1/210 (0.48%) 
Keratitis secondary to Sjogren's   1/211 (0.47%)  0/210 (0.00%) 
Mild TASS (toxic anterior segment syndrome)   1/211 (0.47%)  1/210 (0.48%) 
Proliferative Diabetic Retinopathy   1/211 (0.47%)  0/210 (0.00%) 
wound leak   0/211 (0.00%)  1/210 (0.48%) 
Mild inflammation secondary to gout   0/211 (0.00%)  1/210 (0.48%) 
Immune system disorders     
Hospitalization: penumonia and flu *  1/211 (0.47%)  1/210 (0.48%) 
Skin and subcutaneous tissue disorders     
Melanoma *  1/211 (0.47%)  1/210 (0.48%) 
Vascular disorders     
Hospitalization: tests and observation of possible transient ischemic attack and dementia *  1/211 (0.47%)  1/210 (0.48%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Investigational Healon5 OVD Approved Healon5 OVD
Affected / at Risk (%) Affected / at Risk (%)
Total   174/211 (82.46%)   173/210 (82.38%) 
Eye disorders     
Posterior capsule opacification   74/211 (35.07%)  78/210 (37.14%) 
Blepharitis/meibomiantis   46/211 (21.80%)  45/210 (21.43%) 
dry eye/superficial punctate keratopathy/punctate epithelialerosion/tear film insufficiency   92/211 (43.60%)  91/210 (43.33%) 
Posterior vitreous detachment   42/211 (19.91%)  38/210 (18.10%) 
Elevated IOP/ocular hypertension   17/211 (8.06%)  17/210 (8.10%) 
Posterior capsule striae/wrinkles   52/211 (24.64%)  52/210 (24.76%) 
Drusen   16/211 (7.58%)  17/210 (8.10%) 
Dermatochalasis   15/211 (7.11%)  17/210 (8.10%) 
Folds in Descemet's   51/211 (24.17%)  57/210 (27.14%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Kendra Hileman, Ph.D., Head of Clinical Sciences
Organization: Abbott Medical Optics, Inc.
Phone: 714-247-8613
Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT02782676     History of Changes
Other Study ID Numbers: VSCO-109-HLN5
First Submitted: May 23, 2016
First Posted: May 25, 2016
Results First Submitted: April 13, 2018
Results First Posted: May 24, 2018
Last Update Posted: May 24, 2018