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

• Sponsor: Abbott Medical Optics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02782676
• Collaborator: (none)
• Enrollment: 241
• Locations: 8
• Arms: 2
• Actual Duration (Months): 10.4
• Patients Per Site: 30.1
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

Prospective, multicenter, paired-eye, randomized, masked, clinical trial of the bacterially-derived Healon5 OVD versus the currently available Healon5 OVD control.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: Investigational Healon5 OVD; Device: Healon5 OVD	N/A

Detailed Description

This study will include only subjects undergoing bilateral, primary, cataract extraction and intraocular lens (IOL) implantation and who meet all of the study inclusion and exclusion criteria in both eyes. Subjects who meet the inclusion/exclusion criteria and agree to participate will be randomly assigned to receive the investigational OVD in one eye and the currently-available (i.e., commercial) OVD in the fellow eye (control). Thus, a single group of subjects will provide data for both the investigational OVD and the control OVD.

Study Design

• Study Type: Interventional
• Actual Enrollment: 241 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Clinical Investigation of the Bacterially-Derived Healon5 Ophthalmic Viscosurgical Device (OVD)
• Actual Study Start Date: Jun 21, 2016
• Actual Primary Completion Date: May 4, 2017
• Actual Study Completion Date: May 4, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Investigational Healon5 OVD Subjects to receive investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.	Device: Investigational Healon5 OVD; ophthalmic viscosurgical device
Active Comparator: Approved Healon5 OVD Subjects to receive investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.	Device: Healon5 OVD; ophthalmic viscosurgical device

Outcome Measures

Primary Outcome Measures

1. Cumulative Rates of Intraocular Pressure (IOP) Spikes 30mm of Mercury (mmHg) or Greater Measured Postoperatively [3 months]

   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%.

2. Mean Percent Endothelial Cell Count (ECC) Change Preoperatively vs. Postoperatively [3 months]

   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%.

Secondary Outcome Measures

1. Ocular Serious Adverse Events (SAE) [3 months]

   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

2. Mean Change in IOP From Baseline [3 months]

   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.

3. Rate of IOP Spikes 30 mmHg or Greater at 3 Month Postoperatively [3 months]

   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.

4. Grade of Inflammation: Epithelial Edema [Upto 3 months]

   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.

5. Grade of Inflammation: Stromal Edema [Upto 3 months]

   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.

6. Grade of Inflammation: Cells [Upto 3 months]

   The grades of inflammation for cells was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.

7. Grade of Inflammation: Flare [Upto 3 months]

   The grades of inflammation for flare was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.

8. Grade of Inflammation: Anterior Synechiae [Upto 3 months]

   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.

9. Grade of Inflammation: Posterior Synechiae [Upto 3 Months]

   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.

10. Grade of Inflammation: Fibrin Presence [Upto 3 Months]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Minimum 22 years of age

• Cataracts for which extraction and posterior IOL implantation have been planned for both eyes

• Potential for postoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or better

• Clear intraocular media, other than cataract

• Availability, willingness and sufficient cognitive awareness to comply with examination procedures

• Signed informed consent and HIPAA authorization

Exclusion Criteria:

• Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)

• Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject

• Prior corneal refractive (LASIK- laser-assisted in situ keratomileusis, LASEK-laser-assisted sub-epithelial keratectomy, RK- radial keratectomy, PRK- photorefractive keratectomy, etc.) or intraocular surgery

• Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level worse than 20/40 Snellen during the study

• Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level worse than 20/40 Snellen during the study.

• Conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects

• Use of systemic or ocular medications that may affect vision

• Prior, current, or anticipated use during the course of the 3-month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery)

• Poorly-controlled diabetes

• Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.).

• Known steroid responder

• Ocular hypertension of ≥ 20 mmHg, medically-controlled ocular hypertension (regardless of IOP value ), or glaucomatous changes in the optic nerve

• Endothelial cell count (ECC) lower than 1800 cells/mm2 preoperatively (based on the lowest value of the three cell counts as taken by the Konan Specular Microscope)

• Known ocular disease or pathology that may affect visual acuity or that may be expected to require retinal laser treatment or other surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.)

• Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes

• Concurrent participation, or participation within 45 days prior to preoperative visit, in any other clinical trial

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Empire Eye & Laser Center	Bakersfield	California	United States	93309
2	Cape Coral Eye Center	Cape Coral	Florida	United States	33904
3	Katzen Eye Care & Laser Center	West Palm Beach	Florida	United States	33401
4	Scott & Christie and Associates	Cranberry Township	Pennsylvania	United States	16066
5	Loden Vision Center	Goodlettsville	Tennessee	United States	37072
6	Whitsett Vision Group	Houston	Texas	United States	77084
7	Parkhurst NuVision	San Antonio	Texas	United States	78229
8	Clarus Eye Centre	Lacey	Washington	United States	98503

Sponsors and Collaborators

• Abbott Medical Optics

Investigators

• Study Director: Kendra Hileman, PhD, Abbott Medical Optics

Study Documents (Full-Text)

• Study Protocol - Sep 21, 2016
• Statistical Analysis Plan - Jan 22, 2016

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Optics
• ClinicalTrials.gov Identifier: NCT02782676
• Other Study ID Numbers: VSCO-109-HLN5
• First Posted: May 25, 2016
• Last Update Posted: May 24, 2018
• Last Verified: May 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Cataract; Hyaluronic Acid

Study Results

Participant Flow

Pre-assignment Detail	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)
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
STARTED	211	210
COMPLETED	211	209
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Subjects Received OVD (Bacterial and/or Animal-Derived)
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 Participants	213
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.7 (8)
Sex: Female, Male (Count of Participants)
Female	124 58.2%
Male	89 41.8%
Race (NIH/OMB) (Count of 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%
Unknown or Not Reported	1 0.5%
Region of Enrollment (Count of Participants)
United States	213 100%

Outcome Measures

1. Primary Outcome

Title	Cumulative Rates of Intraocular Pressure (IOP) Spikes 30mm of Mercury (mmHg) or Greater Measured Postoperatively
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

Outcome Measure Data

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)
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
Measure Participants	208	208
Count of Participants [Participants]	17 8%	13 NaN

2. Primary Outcome

Title	Mean Percent Endothelial Cell Count (ECC) Change Preoperatively vs. Postoperatively
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

Outcome Measure Data

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)
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
Measure Participants	206	206
Mean (95% Confidence Interval) [percent change]	-5.55	-6.66

3. Secondary Outcome

Title	Ocular Serious Adverse Events (SAE)
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

Outcome Measure Data

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)
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
Measure Participants	211	210
Measure Eyes	211	210
Conjunctival Laceration	0	1
Cystoid macular edema	0	1
Elevated IOP/IOP spike (30 mmHg or greater)*	18	13
IOP spike <30 mmHg, requiring treatment*	0	3
Keratitis secondary to Sjogren's	1	0
Mild TASS	1	1
Proliferative Diabetic Retinopathy	1	0
Wound leak	0	1
Mild inflammation secondary to gout	0	1
Total eyes with no SAEs	190	189

4. Secondary Outcome

Title	Mean Change in IOP From Baseline
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

Outcome Measure Data

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)
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
Measure Participants	208	208
Measure eyes	208	208
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
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

Outcome Measure Data

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)
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
Measure Participants	208	208
Measure eyes	208	208
6 Hours	16	9
1 Day	4	5
1 Week	0	0
1 Month	0	0
3 Months	0	0

6. Secondary Outcome

Title	Grade of Inflammation: Epithelial Edema
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

Outcome Measure Data

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)
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
Measure Participants	211	210
Measure eyes	211	210
None (0)	144	141
Trace (+1)	42	47
Mild (+2)	20	17
Moderate (+3)	5	5
Severe (+4)	0	0
None (0)	173	175
Trace (+1)	24	21
Mild (+2)	10	11
Moderate (+3)	3	2
Severe (+4)	1	1
None (0)	200	203
Trace (+1)	11	5
Mild (+2)	0	2
Moderate (+3)	0	0
Severe (+4)	0	0
None (0)	210	208
Trace (+1)	1	1
Mild (+2)	0	0
Moderate (+3)	0	0
Severe (+4)	0	0
None (0)	211	209
Trace (+1)	0	0
Mild (+2)	0	0
Moderate (+3)	0	0
Severe (+4)	0	0

7. Secondary Outcome

Title	Grade of Inflammation: Stromal Edema
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

Outcome Measure Data

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)
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
Measure Participants	211	210
Measure eyes	211	210
None (0)	178	173
Trace (+1)	27	30
Mild (+2)	5	6
Moderate (+3)	1	1
Severe (+4)	0	0
None (0)	184	182
Trace (+1)	24	23
Mild (+2)	3	4
Moderate (+3)	0	0
Severe (+4)	0	1
None (0)	207	206
Trace (+1)	4	3
Mild (+2)	0	1
Moderate (+3)	0	0
Severe (+4)	0	0
None (0)	211	209
Trace (+1)	0	0
Mild (+2)	0	0
Moderate (+3)	0	0
Severe (+4)	0	0
None (0)	211	209
Trace (+1)	0	0
Mild (+2)	0	0
Moderate (+3)	0	0
Severe (+4)	0	0

8. Secondary Outcome

Title	Grade of Inflammation: Cells
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

Outcome Measure Data

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)
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
Measure Participants	211	210
Measure eyes	211	210
None (0)	27	22
Rare (0.5+)	45	51
Trace (1+)	116	105
Mild (2+)	21	26
Moderate (3+)	1	6
Severe (4+)	1	0
None (0)	46	36
Rare (0.5+)	29	38
Trace (1+)	123	121
Mild (2+)	9	14
Moderate (3+)	4	1
Severe (4+)	0	0
None (0)	119	134
Rare (0.5+)	87	72
Trace (1+)	5	4
Mild (2+)	0	0
Moderate (3+)	0	0
Severe (4+)	0	0
None (0)	196	193
Rare (0.5+)	14	16
Trace (1+)	1	0
Mild (2+)	0	0
Moderate (3+)	0	0
Severe (4+)	0	0
None (0)	207	206
Rare (0.5+)	4	3
Trace (1+)	0	0
Mild (2+)	0	0
Moderate (3+)	0	0
Severe (4+)	0	0

9. Secondary Outcome

Title	Grade of Inflammation: Flare
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

Outcome Measure Data

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)
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
Measure Participants	211	210
Measure eyes	211	210
None (0)	118	112
Faint/Trace/Mild (1+)	93	91
Moderate (2+)	0	7
None (0)	145	154
Faint/Trace/Mild (1+)	64	55
Moderate (2+)	2	1
None (0)	204	206
Faint/Trace/Mild (1+)	7	4
Moderate (2+)	0	0
None (0)	210	209
Faint/Trace/Mild (1+)	1	0
Moderate (2+)	0	0
None (0)	211	208
Faint/Trace/Mild (1+)	0	1
Moderate (2+)	0	0

10. Secondary Outcome

Title	Grade of Inflammation: Anterior Synechiae
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

Outcome Measure Data

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)
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
Measure Participants	211	210
Measure eyes	211	210
None (0)	211	210
Trace (+1)	0	0
Mild (+2)	0	0
None (0)	211	209
Trace (+1)	0	0
Mild (+2)	0	1
None (0)	210	210
Trace (+1)	1	0
Mild (+2)	0	0
None (0)	211	209
Trace (+1)	0	0
Mild (+2)	0	0
None (0)	211	209
Trace (+1)	0	0
Mild (+2)	0	0

11. Secondary Outcome

Title	Grade of Inflammation: Posterior Synechiae
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

Outcome Measure Data

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)
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
Measure Participants	211	210
Measure eyes	211	210
None (0)	210	210
Trace (+1)	1	0
None (0)	211	210
Trace (+1)	0	0
None (0)	211	210
Trace (+1)	0	0
None (0)	211	209
Trace (+1)	0	0
None (0)	211	209
Trace (+1)	0	0

12. Secondary Outcome

Title	Grade of Inflammation: Fibrin Presence
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

Outcome Measure Data

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)
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
Measure Participants	211	210
Measure eyes	211	210
None (0)	210	210
Trace (+1)	0	0
Mild (+2)	1	0
None (0)	210	209
Trace (+1)	1	1
Mild (+2)	0	0
None (0)	211	210
Trace (+1)	0	0
Mild (+2)	0	0
None (0)	210	209
Trace (+1)	1	0
Mild (+2)	0	0
None (0)	211	209
Trace (+1)	0	0
Mild (+2)	0	0

Adverse Events

Time Frame	3 months
Arm/Group Title	Investigational Healon5 OVD		Approved Healon5 OVD
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/211 (0%)		0/210 (0%)
Serious Adverse Events
	Investigational Healon5 OVD		Approved Healon5 OVD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	24/211 (11.4%)		24/210 (11.4%)
Eye disorders
Elevated IOP/IOP Spike (30 mmHg or greater)	18/211 (8.5%)		13/210 (6.2%)
IOP spike <30 mmHg, requiring treatment	0/211 (0%)		3/210 (1.4%)
Conjunctival Laceration	0/211 (0%)		1/210 (0.5%)
Cystoid macular edema	0/211 (0%)		1/210 (0.5%)
Keratitis secondary to Sjogren's	1/211 (0.5%)		0/210 (0%)
Mild TASS (toxic anterior segment syndrome)	1/211 (0.5%)		1/210 (0.5%)
Proliferative Diabetic Retinopathy	1/211 (0.5%)		0/210 (0%)
wound leak	0/211 (0%)		1/210 (0.5%)
Mild inflammation secondary to gout	0/211 (0%)		1/210 (0.5%)
Immune system disorders
Hospitalization: penumonia and flu	1/211 (0.5%)		1/210 (0.5%)
Skin and subcutaneous tissue disorders
Melanoma	1/211 (0.5%)		1/210 (0.5%)
Vascular disorders
Hospitalization: tests and observation of possible transient ischemic attack and dementia	1/211 (0.5%)		1/210 (0.5%)
Other (Not Including Serious) Adverse Events
	Investigational Healon5 OVD		Approved Healon5 OVD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	174/211 (82.5%)		173/210 (82.4%)
Eye disorders
Posterior capsule opacification	74/211 (35.1%)		78/210 (37.1%)
Blepharitis/meibomiantis	46/211 (21.8%)		45/210 (21.4%)
dry eye/superficial punctate keratopathy/punctate epithelialerosion/tear film insufficiency	92/211 (43.6%)		91/210 (43.3%)
Posterior vitreous detachment	42/211 (19.9%)		38/210 (18.1%)
Elevated IOP/ocular hypertension	17/211 (8.1%)		17/210 (8.1%)
Posterior capsule striae/wrinkles	52/211 (24.6%)		52/210 (24.8%)
Drusen	16/211 (7.6%)		17/210 (8.1%)
Dermatochalasis	15/211 (7.1%)		17/210 (8.1%)
Folds in Descemet's	51/211 (24.2%)		57/210 (27.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.