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)
241
Enrollment
8
Locations
2
Arms
10.4
Actual Duration (Months)
30.1
Patients Per Site
2.9
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

SiteCityStateCountryPostal Code
1Empire Eye & Laser CenterBakersfieldCaliforniaUnited States93309
2Cape Coral Eye CenterCape CoralFloridaUnited States33904
3Katzen Eye Care & Laser CenterWest Palm BeachFloridaUnited States33401
4Scott & Christie and AssociatesCranberry TownshipPennsylvaniaUnited States16066
5Loden Vision CenterGoodlettsvilleTennesseeUnited States37072
6Whitsett Vision GroupHoustonTexasUnited States77084
7Parkhurst NuVisionSan AntonioTexasUnited States78229
8Clarus Eye CentreLaceyWashingtonUnited States98503

Sponsors and Collaborators

  • Abbott Medical Optics

Investigators

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

Study Documents (Full-Text)

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:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail15 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 TitleInvestigational Healon5 OVD (Bacterially-Derived)Approved Healon5 OVD (Animal-Derived)
Arm/Group DescriptionSubject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Investigational Healon5 OVD: ophthalmic viscosurgical deviceSubjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Healon5 OVD: ophthalmic viscosurgical device
Period Title: Overall Study
STARTED211210
COMPLETED211209
NOT COMPLETED01

Baseline Characteristics

Arm/Group TitleSubjects Received OVD (Bacterial and/or Animal-Derived)
Arm/Group DescriptionSubject 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 Participants213
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
TitleCumulative Rates of Intraocular Pressure (IOP) Spikes 30mm of Mercury (mmHg) or Greater Measured Postoperatively
DescriptionThe 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 Frame3 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 TitleInvestigational Healon5 OVD (Bacterially-Derived)Approved Healon5 OVD (Animal-Derived)
Arm/Group DescriptionSubject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Investigational Healon5 OVD: ophthalmic viscosurgical deviceSubjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Healon5 OVD: ophthalmic viscosurgical device
Measure Participants208208
Count of Participants [Participants]
17
8%
13
NaN
2. Primary Outcome
TitleMean Percent Endothelial Cell Count (ECC) Change Preoperatively vs. Postoperatively
DescriptionThe 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 Frame3 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 TitleInvestigational Healon5 OVD (Bacterially-Derived)Approved Healon5 OVD (Animal-Derived)
Arm/Group DescriptionSubject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Investigational Healon5 OVD: ophthalmic viscosurgical deviceSubjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Healon5 OVD: ophthalmic viscosurgical device
Measure Participants206206
Mean (95% Confidence Interval) [percent change]
-5.55
-6.66
3. Secondary Outcome
TitleOcular Serious Adverse Events (SAE)
DescriptionOcular 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 Frame3 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 TitleInvestigational Healon5 OVD (Bacterially-Derived)Approved Healon5 OVD (Animal-Derived)
Arm/Group DescriptionSubject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Investigational Healon5 OVD: ophthalmic viscosurgical deviceSubjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Healon5 OVD: ophthalmic viscosurgical device
Measure Participants211210
Measure Eyes211210
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
TitleMean Change in IOP From Baseline
DescriptionThe 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 Frame3 months

Outcome Measure Data

Analysis Population Description
Results are based on paired-eye subjects included in the safety population.
Arm/Group TitleInvestigational Healon5 OVD (Bacterially-Derived)Approved Healon5 OVD (Animal-Derived)
Arm/Group DescriptionSubject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Investigational Healon5 OVD: ophthalmic viscosurgical deviceSubjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Healon5 OVD: ophthalmic viscosurgical device
Measure Participants208208
Measure eyes208208
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
TitleRate of IOP Spikes 30 mmHg or Greater at 3 Month Postoperatively
DescriptionThe 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 Frame3 months

Outcome Measure Data

Analysis Population Description
Results are based on paired-eye subjects included in the safety population.
Arm/Group TitleInvestigational Healon5 OVD (Bacterially-Derived)Approved Healon5 OVD (Animal-Derived)
Arm/Group DescriptionSubject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Investigational Healon5 OVD: ophthalmic viscosurgical deviceSubjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Healon5 OVD: ophthalmic viscosurgical device
Measure Participants208208
Measure eyes208208
6 Hours
16
9
1 Day
4
5
1 Week
0
0
1 Month
0
0
3 Months
0
0
6. Secondary Outcome
TitleGrade of Inflammation: Epithelial Edema
DescriptionThe 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 FrameUpto 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 TitleInvestigational Healon5 OVD (Bacterially-Derived)Approved Healon5 OVD (Animal-Derived)
Arm/Group DescriptionSubject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Investigational Healon5 OVD: ophthalmic viscosurgical deviceSubjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Healon5 OVD: ophthalmic viscosurgical device
Measure Participants211210
Measure eyes211210
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
TitleGrade of Inflammation: Stromal Edema
DescriptionThe 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 FrameUpto 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 TitleInvestigational Healon5 OVD (Bacterially-Derived)Approved Healon5 OVD (Animal-Derived)
Arm/Group DescriptionSubject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Investigational Healon5 OVD: ophthalmic viscosurgical deviceSubjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Healon5 OVD: ophthalmic viscosurgical device
Measure Participants211210
Measure eyes211210
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
TitleGrade of Inflammation: Cells
DescriptionThe grades of inflammation for cells was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.
Time FrameUpto 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 TitleInvestigational Healon5 OVD (Bacterially-Derived)Approved Healon5 OVD (Animal-Derived)
Arm/Group DescriptionSubject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Investigational Healon5 OVD: ophthalmic viscosurgical deviceSubjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Healon5 OVD: ophthalmic viscosurgical device
Measure Participants211210
Measure eyes211210
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
TitleGrade of Inflammation: Flare
DescriptionThe grades of inflammation for flare was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.
Time FrameUpto 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 TitleInvestigational Healon5 OVD (Bacterially-Derived)Approved Healon5 OVD (Animal-Derived)
Arm/Group DescriptionSubject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Investigational Healon5 OVD: ophthalmic viscosurgical deviceSubjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Healon5 OVD: ophthalmic viscosurgical device
Measure Participants211210
Measure eyes211210
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
TitleGrade of Inflammation: Anterior Synechiae
DescriptionThe 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 FrameUpto 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 TitleInvestigational Healon5 OVD (Bacterially-Derived)Approved Healon5 OVD (Animal-Derived)
Arm/Group DescriptionSubject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Investigational Healon5 OVD: ophthalmic viscosurgical deviceSubjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Healon5 OVD: ophthalmic viscosurgical device
Measure Participants211210
Measure eyes211210
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
TitleGrade of Inflammation: Posterior Synechiae
DescriptionThe 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 FrameUpto 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 TitleInvestigational Healon5 OVD (Bacterially-Derived)Approved Healon5 OVD (Animal-Derived)
Arm/Group DescriptionSubject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Investigational Healon5 OVD: ophthalmic viscosurgical deviceSubjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Healon5 OVD: ophthalmic viscosurgical device
Measure Participants211210
Measure eyes211210
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
TitleGrade of Inflammation: Fibrin Presence
DescriptionThe 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 FrameUpto 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 TitleInvestigational Healon5 OVD (Bacterially-Derived)Approved Healon5 OVD (Animal-Derived)
Arm/Group DescriptionSubject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Investigational Healon5 OVD: ophthalmic viscosurgical deviceSubjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Healon5 OVD: ophthalmic viscosurgical device
Measure Participants211210
Measure eyes211210
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 Frame3 months
Adverse Event Reporting Description
Arm/Group TitleInvestigational Healon5 OVDApproved Healon5 OVD
Arm/Group DescriptionSubjects to receive investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Investigational Healon5 OVD: ophthalmic viscosurgical deviceSubjects 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 OVDApproved Healon5 OVD
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/211 (0%) 0/210 (0%)
Serious Adverse Events
Investigational Healon5 OVDApproved Healon5 OVD
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total24/211 (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 treatment0/211 (0%) 3/210 (1.4%)
Conjunctival Laceration0/211 (0%) 1/210 (0.5%)
Cystoid macular edema0/211 (0%) 1/210 (0.5%)
Keratitis secondary to Sjogren's1/211 (0.5%) 0/210 (0%)
Mild TASS (toxic anterior segment syndrome)1/211 (0.5%) 1/210 (0.5%)
Proliferative Diabetic Retinopathy1/211 (0.5%) 0/210 (0%)
wound leak0/211 (0%) 1/210 (0.5%)
Mild inflammation secondary to gout0/211 (0%) 1/210 (0.5%)
Immune system disorders
Hospitalization: penumonia and flu1/211 (0.5%) 1/210 (0.5%)
Skin and subcutaneous tissue disorders
Melanoma1/211 (0.5%) 1/210 (0.5%)
Vascular disorders
Hospitalization: tests and observation of possible transient ischemic attack and dementia1/211 (0.5%) 1/210 (0.5%)
Other (Not Including Serious) Adverse Events
Investigational Healon5 OVDApproved Healon5 OVD
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total174/211 (82.5%) 173/210 (82.4%)
Eye disorders
Posterior capsule opacification74/211 (35.1%) 78/210 (37.1%)
Blepharitis/meibomiantis46/211 (21.8%) 45/210 (21.4%)
dry eye/superficial punctate keratopathy/punctate epithelialerosion/tear film insufficiency92/211 (43.6%) 91/210 (43.3%)
Posterior vitreous detachment42/211 (19.9%) 38/210 (18.1%)
Elevated IOP/ocular hypertension17/211 (8.1%) 17/210 (8.1%)
Posterior capsule striae/wrinkles52/211 (24.6%) 52/210 (24.8%)
Drusen16/211 (7.6%) 17/210 (8.1%)
Dermatochalasis15/211 (7.1%) 17/210 (8.1%)
Folds in Descemet's51/211 (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.

Results Point of Contact

Name/TitleKendra Hileman, Ph.D., Head of Clinical Sciences
OrganizationAbbott Medical Optics, Inc.
Phone714-247-8613
Emailkendra.hileman@abbott.com
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