Cataract
Conditions
Brief summary
Prospective, multicenter, paired-eye, randomized, masked, clinical trial of the bacterially-derived Healon5 OVD versus the currently available Healon5 OVD control.
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.
Interventions
DEVICEInvestigational Healon5 OVD
ophthalmic viscosurgical device
DEVICEHealon5 OVD
ophthalmic viscosurgical device
Sponsors
Abbott Medical Optics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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%. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Subjects Received OVD (Bacterial and/or Animal-Derived) 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) | 213 |
| Total | 213 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Subjects Received OVD (Bacterial and/or Animal-Derived) |
|---|---|
| Age, Continuous | 68.7 years STANDARD_DEVIATION 8 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 200 Participants |
| Region of Enrollment United States | 213 Participants |
| Sex: Female, Male Female | 124 Participants |
| Sex: Female, Male Male | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 211 | 0 / 210 |
| other Total, other adverse events | 174 / 211 | 173 / 210 |
| serious Total, serious adverse events | 24 / 211 | 24 / 210 |
Outcome results
Primary
Cumulative Rates of Intraocular Pressure (IOP) Spikes 30mm of Mercury (mmHg) or Greater Measured Postoperatively
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
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Investigational Healon5 OVD (Bacterially-Derived) | Cumulative Rates of Intraocular Pressure (IOP) Spikes 30mm of Mercury (mmHg) or Greater Measured Postoperatively | 17 Participants |
| Approved Healon5 OVD (Animal-Derived) | Cumulative Rates of Intraocular Pressure (IOP) Spikes 30mm of Mercury (mmHg) or Greater Measured Postoperatively | 13 Participants |
Primary
Mean Percent Endothelial Cell Count (ECC) Change Preoperatively vs. Postoperatively
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
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| Investigational Healon5 OVD (Bacterially-Derived) | Mean Percent Endothelial Cell Count (ECC) Change Preoperatively vs. Postoperatively | -5.55 percent change |
| Approved Healon5 OVD (Animal-Derived) | Mean Percent Endothelial Cell Count (ECC) Change Preoperatively vs. Postoperatively | -6.66 percent change |
Secondary
Grade of Inflammation: Anterior Synechiae
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
Population: 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 | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Anterior Synechiae | Anterior Synechiae at 1 Day | Trace (+1) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Anterior Synechiae | Anterior Synechiae at 1 Week | Mild (+2) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Anterior Synechiae | Anterior Synechiae at 6 Hours | Trace (+1) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Anterior Synechiae | Anterior Synechiae at 1 Month | None (0) | 211 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Anterior Synechiae | Anterior Synechiae at 1 Day | Mild (+2) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Anterior Synechiae | Anterior Synechiae at 1 Month | Trace (+1) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Anterior Synechiae | Anterior Synechiae at 1 Day | None (0) | 211 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Anterior Synechiae | Anterior Synechiae at 1 Month | Mild (+2) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Anterior Synechiae | Anterior Synechiae at 1 Week | None (0) | 210 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Anterior Synechiae | Anterior Synechiae at 3 Months | None (0) | 211 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Anterior Synechiae | Anterior Synechiae at 6 Hours | Mild (+2) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Anterior Synechiae | Anterior Synechiae at 3 Months | Trace (+1) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Anterior Synechiae | Anterior Synechiae at 1 Week | Trace (+1) | 1 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Anterior Synechiae | Anterior Synechiae at 3 Months | Mild (+2) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Anterior Synechiae | Anterior Synechiae at 6 Hours | None (0) | 211 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Anterior Synechiae | Anterior Synechiae at 3 Months | Mild (+2) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Anterior Synechiae | Anterior Synechiae at 6 Hours | None (0) | 210 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Anterior Synechiae | Anterior Synechiae at 6 Hours | Trace (+1) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Anterior Synechiae | Anterior Synechiae at 6 Hours | Mild (+2) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Anterior Synechiae | Anterior Synechiae at 1 Day | None (0) | 209 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Anterior Synechiae | Anterior Synechiae at 1 Day | Trace (+1) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Anterior Synechiae | Anterior Synechiae at 1 Day | Mild (+2) | 1 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Anterior Synechiae | Anterior Synechiae at 1 Week | None (0) | 210 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Anterior Synechiae | Anterior Synechiae at 1 Week | Trace (+1) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Anterior Synechiae | Anterior Synechiae at 1 Week | Mild (+2) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Anterior Synechiae | Anterior Synechiae at 1 Month | None (0) | 209 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Anterior Synechiae | Anterior Synechiae at 1 Month | Trace (+1) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Anterior Synechiae | Anterior Synechiae at 1 Month | Mild (+2) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Anterior Synechiae | Anterior Synechiae at 3 Months | None (0) | 209 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Anterior Synechiae | Anterior Synechiae at 3 Months | Trace (+1) | 0 eyes |
Secondary
Grade of Inflammation: Cells
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
Population: 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 | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Cells | Cells at 6 Hours | Mild (2+) | 21 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Cells | Cells at 6 Hours | Trace (1+) | 116 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Cells | Cells at 1 Week | Moderate (3+) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Cells | Cells at 1 Week | Severe (4+) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Cells | Cells at 1 Month | None (0) | 196 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Cells | Cells at 6 Hours | None (0) | 27 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Cells | Cells at 6 Hours | Rare (0.5+) | 45 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Cells | Cells at 6 Hours | Moderate (3+) | 1 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Cells | Cells at 6 Hours | Severe (4+) | 1 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Cells | Cells at 1 Day | None (0) | 46 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Cells | Cells at 1 Day | Rare (0.5+) | 29 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Cells | Cells at 1 Day | Trace (1+) | 123 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Cells | Cells at 1 Day | Mild (2+) | 9 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Cells | Cells at 1 Day | Moderate (3+) | 4 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Cells | Cells at 1 Day | Severe (4+) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Cells | Cells at 1 Week | None (0) | 119 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Cells | Cells at 1 Week | Rare (0.5+) | 87 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Cells | Cells at 1 Week | Trace (1+) | 5 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Cells | Cells at 1 Week | Mild (2+) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Cells | Cells at 1 Month | Rare (0.5+) | 14 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Cells | Cells at 1 Month | Trace (1+) | 1 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Cells | Cells at 1 Month | Mild (2+) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Cells | Cells at 1 Month | Moderate (3+) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Cells | Cells at 1 Month | Severe (4+) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Cells | Cells at 3 Months | None (0) | 207 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Cells | Cells at 3 Months | Rare (0.5+) | 4 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Cells | Cells at 3 Months | Trace (1+) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Cells | Cells at 3 Months | Mild (2+) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Cells | Cells at 3 Months | Moderate (3+) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Cells | Cells at 3 Months | Severe (4+) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Cells | Cells at 1 Month | Mild (2+) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Cells | Cells at 3 Months | Severe (4+) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Cells | Cells at 1 Day | Severe (4+) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Cells | Cells at 6 Hours | Trace (1+) | 105 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Cells | Cells at 1 Week | Mild (2+) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Cells | Cells at 3 Months | Rare (0.5+) | 3 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Cells | Cells at 1 Week | Moderate (3+) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Cells | Cells at 1 Week | None (0) | 134 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Cells | Cells at 1 Week | Severe (4+) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Cells | Cells at 1 Month | Moderate (3+) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Cells | Cells at 1 Week | Rare (0.5+) | 72 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Cells | Cells at 6 Hours | None (0) | 22 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Cells | Cells at 3 Months | Mild (2+) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Cells | Cells at 6 Hours | Rare (0.5+) | 51 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Cells | Cells at 1 Month | None (0) | 193 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Cells | Cells at 6 Hours | Mild (2+) | 26 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Cells | Cells at 1 Week | Trace (1+) | 4 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Cells | Cells at 6 Hours | Moderate (3+) | 6 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Cells | Cells at 1 Month | Severe (4+) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Cells | Cells at 6 Hours | Severe (4+) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Cells | Cells at 3 Months | Trace (1+) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Cells | Cells at 1 Day | None (0) | 36 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Cells | Cells at 1 Month | Rare (0.5+) | 16 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Cells | Cells at 1 Day | Rare (0.5+) | 38 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Cells | Cells at 3 Months | None (0) | 206 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Cells | Cells at 1 Day | Trace (1+) | 121 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Cells | Cells at 1 Month | Trace (1+) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Cells | Cells at 1 Day | Mild (2+) | 14 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Cells | Cells at 3 Months | Moderate (3+) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Cells | Cells at 1 Day | Moderate (3+) | 1 eyes |
Secondary
Grade of Inflammation: Epithelial Edema
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
Population: 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 | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 6 Hours | Mild (+2) | 20 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 1 Week | Moderate (+3) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 1 Day | Mild (+2) | 10 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 1 Week | Severe (+4) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 6 Hours | Severe (+4) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 1 Month | None (0) | 210 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 1 Day | Moderate (+3) | 3 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 1 Month | Trace (+1) | 1 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 6 Hours | Trace (+1) | 42 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 1 Month | Mild (+2) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 1 Day | Severe (+4) | 1 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 1 Month | Moderate (+3) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 1 Day | None (0) | 173 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 1 Month | Severe (+4) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 1 Week | None (0) | 200 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 3 Month | None (0) | 211 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 6 Hours | Moderate (+3) | 5 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 3 Month | Trace (+1) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 1 Week | Trace (+1) | 11 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 3 Month | Mild (+2) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 1 Day | Trace (+1) | 24 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 3 Month | Moderate (+3) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 1 Week | Mild (+2) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 3 Month | Severe (+4) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 6 Hours | None (0) | 144 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 3 Month | Severe (+4) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 6 Hours | None (0) | 141 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 6 Hours | Trace (+1) | 47 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 6 Hours | Mild (+2) | 17 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 6 Hours | Moderate (+3) | 5 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 6 Hours | Severe (+4) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 1 Day | None (0) | 175 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 1 Day | Trace (+1) | 21 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 1 Day | Mild (+2) | 11 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 1 Day | Moderate (+3) | 2 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 1 Day | Severe (+4) | 1 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 1 Week | None (0) | 203 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 1 Week | Trace (+1) | 5 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 1 Week | Mild (+2) | 2 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 1 Week | Moderate (+3) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 1 Week | Severe (+4) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 1 Month | None (0) | 208 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 1 Month | Trace (+1) | 1 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 1 Month | Mild (+2) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 1 Month | Moderate (+3) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 1 Month | Severe (+4) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 3 Month | None (0) | 209 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 3 Month | Trace (+1) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 3 Month | Mild (+2) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Epithelial Edema | Epithelial Edema at 3 Month | Moderate (+3) | 0 eyes |
Secondary
Grade of Inflammation: Fibrin Presence
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
Population: 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 | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Fibrin Presence | Fibrin Presence at 1 Day | Trace (+1) | 1 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Fibrin Presence | Fibrin Presence at 1 Week | Mild (+2) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Fibrin Presence | Fibrin Presence at 6 Hours | Trace (+1) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Fibrin Presence | Fibrin Presence at 1 Month | None (0) | 210 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Fibrin Presence | Fibrin Presence at 1 Day | Mild (+2) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Fibrin Presence | Fibrin Presence at 1 Month | Trace (+1) | 1 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Fibrin Presence | Fibrin Presence at 1 Day | None (0) | 210 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Fibrin Presence | Fibrin Presence at 1 Month | Mild (+2) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Fibrin Presence | Fibrin Presence at 1 Week | None (0) | 211 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Fibrin Presence | Fibrin Presence at 3 Months | None (0) | 211 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Fibrin Presence | Fibrin Presence at 6 Hours | Mild (+2) | 1 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Fibrin Presence | Fibrin Presence at 3 Months | Trace (+1) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Fibrin Presence | Fibrin Presence at 1 Week | Trace (+1) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Fibrin Presence | Fibrin Presence at 3 Months | Mild (+2) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Fibrin Presence | Fibrin Presence at 6 Hours | None (0) | 210 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Fibrin Presence | Fibrin Presence at 3 Months | Mild (+2) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Fibrin Presence | Fibrin Presence at 6 Hours | None (0) | 210 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Fibrin Presence | Fibrin Presence at 6 Hours | Trace (+1) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Fibrin Presence | Fibrin Presence at 6 Hours | Mild (+2) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Fibrin Presence | Fibrin Presence at 1 Day | None (0) | 209 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Fibrin Presence | Fibrin Presence at 1 Day | Trace (+1) | 1 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Fibrin Presence | Fibrin Presence at 1 Day | Mild (+2) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Fibrin Presence | Fibrin Presence at 1 Week | None (0) | 210 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Fibrin Presence | Fibrin Presence at 1 Week | Trace (+1) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Fibrin Presence | Fibrin Presence at 1 Week | Mild (+2) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Fibrin Presence | Fibrin Presence at 1 Month | None (0) | 209 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Fibrin Presence | Fibrin Presence at 1 Month | Trace (+1) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Fibrin Presence | Fibrin Presence at 1 Month | Mild (+2) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Fibrin Presence | Fibrin Presence at 3 Months | None (0) | 209 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Fibrin Presence | Fibrin Presence at 3 Months | Trace (+1) | 0 eyes |
Secondary
Grade of Inflammation: Flare
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
Population: 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 | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Flare | Flares at 1 Day | Moderate (2+) | 2 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Flare | Flares at 1 Month | None (0) | 210 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Flare | Flares at 6 Hours | Moderate (2+) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Flare | Flares at 1 Month | Faint/Trace/Mild (1+) | 1 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Flare | Flares at 1 Week | None (0) | 204 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Flare | Flares at 1 Month | Moderate (2+) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Flare | Flares at 1 Day | Faint/Trace/Mild (1+) | 64 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Flare | Flares at 6 Months | None (0) | 211 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Flare | Flares at 1 Week | Faint/Trace/Mild (1+) | 7 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Flare | Flares at 6 Months | Faint/Trace/Mild (1+) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Flare | Flares at 1 Day | None (0) | 145 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Flare | Flares at 6 Months | Moderate (2+) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Flare | Flares at 1 Week | Moderate (2+) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Flare | Flares at 6 Hours | None (0) | 118 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Flare | Flares at 6 Hours | Faint/Trace/Mild (1+) | 93 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Flare | Flares at 6 Hours | None (0) | 112 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Flare | Flares at 6 Hours | Faint/Trace/Mild (1+) | 91 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Flare | Flares at 6 Hours | Moderate (2+) | 7 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Flare | Flares at 1 Day | None (0) | 154 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Flare | Flares at 1 Day | Faint/Trace/Mild (1+) | 55 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Flare | Flares at 1 Day | Moderate (2+) | 1 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Flare | Flares at 1 Week | None (0) | 206 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Flare | Flares at 1 Week | Faint/Trace/Mild (1+) | 4 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Flare | Flares at 1 Week | Moderate (2+) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Flare | Flares at 1 Month | None (0) | 209 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Flare | Flares at 1 Month | Faint/Trace/Mild (1+) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Flare | Flares at 1 Month | Moderate (2+) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Flare | Flares at 6 Months | None (0) | 208 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Flare | Flares at 6 Months | Faint/Trace/Mild (1+) | 1 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Flare | Flares at 6 Months | Moderate (2+) | 0 eyes |
Secondary
Grade of Inflammation: Posterior Synechiae
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
Population: 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 | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Posterior Synechiae | Posterior Synechiae at 6 Hours | None (0) | 210 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Posterior Synechiae | Posterior Synechiae at 6 Hours | Trace (+1) | 1 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Posterior Synechiae | Posterior Synechiae at 1 Day | None (0) | 211 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Posterior Synechiae | Posterior Synechiae at 1 Day | Trace (+1) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Posterior Synechiae | Posterior Synechiae at 1 Week | None (0) | 211 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Posterior Synechiae | Posterior Synechiae at 1 Week | Trace (+1) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Posterior Synechiae | Posterior Synechiae at 1 Month | None (0) | 211 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Posterior Synechiae | Posterior Synechiae at 1 Month | Trace (+1) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Posterior Synechiae | Posterior Synechiae 3 Months | None (0) | 211 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Posterior Synechiae | Posterior Synechiae 3 Months | Trace (+1) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Posterior Synechiae | Posterior Synechiae at 1 Month | Trace (+1) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Posterior Synechiae | Posterior Synechiae at 6 Hours | None (0) | 210 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Posterior Synechiae | Posterior Synechiae at 1 Week | Trace (+1) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Posterior Synechiae | Posterior Synechiae at 6 Hours | Trace (+1) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Posterior Synechiae | Posterior Synechiae 3 Months | Trace (+1) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Posterior Synechiae | Posterior Synechiae at 1 Day | None (0) | 210 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Posterior Synechiae | Posterior Synechiae at 1 Month | None (0) | 209 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Posterior Synechiae | Posterior Synechiae at 1 Day | Trace (+1) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Posterior Synechiae | Posterior Synechiae 3 Months | None (0) | 209 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Posterior Synechiae | Posterior Synechiae at 1 Week | None (0) | 210 eyes |
Secondary
Grade of Inflammation: Stromal Edema
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
Population: 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 | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 6 Hours | Trace (+1) | 27 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 1 Week | Moderate (+3) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 1 Day | Mild (+2) | 3 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 1 Week | Severe (+4) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 6 Hours | Moderate (+3) | 1 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 1 Month | None (0) | 211 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 1 Day | Moderate (+3) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 1 Month | Trace (+1) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 6 Hours | None (0) | 178 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 1 Month | Mild (+2) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 1 Day | Severe (+4) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 1 Month | Moderate (+3) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 6 Hours | Severe (+4) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 1 Month | Severe (+4) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 1 Week | None (0) | 207 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 3 Months | None (0) | 211 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 6 Hours | Mild (+2) | 5 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 3 Months | Trace (+1) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 1 Week | Trace (+1) | 4 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 3 Months | Mild (+2) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 1 Day | None (0) | 184 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 3 Months | Moderate (+3) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 1 Week | Mild (+2) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 3 Months | Severe (+4) | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 1 Day | Trace (+1) | 24 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 3 Months | Severe (+4) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 1 Day | Trace (+1) | 23 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 6 Hours | None (0) | 173 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 6 Hours | Trace (+1) | 30 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 6 Hours | Mild (+2) | 6 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 6 Hours | Moderate (+3) | 1 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 6 Hours | Severe (+4) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 1 Day | None (0) | 182 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 1 Day | Mild (+2) | 4 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 1 Day | Moderate (+3) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 1 Day | Severe (+4) | 1 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 1 Week | None (0) | 206 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 1 Week | Trace (+1) | 3 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 1 Week | Mild (+2) | 1 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 1 Week | Moderate (+3) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 1 Week | Severe (+4) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 1 Month | None (0) | 209 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 1 Month | Trace (+1) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 1 Month | Mild (+2) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 1 Month | Moderate (+3) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 1 Month | Severe (+4) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 3 Months | None (0) | 209 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 3 Months | Trace (+1) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 3 Months | Mild (+2) | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Grade of Inflammation: Stromal Edema | Stromal Edema at 3 Months | Moderate (+3) | 0 eyes |
Secondary
Mean Change in IOP From Baseline
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
Population: Results are based on paired-eye subjects included in the safety population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Investigational Healon5 OVD (Bacterially-Derived) | Mean Change in IOP From Baseline | Change in IOP from Baseline (mmHg) at 1 day | 3.9 mmHg | Standard Deviation 7 |
| Investigational Healon5 OVD (Bacterially-Derived) | Mean Change in IOP From Baseline | Change in IOP from Baseline (mmHg) 1 month | -0.6 mmHg | Standard Deviation 2.8 |
| Investigational Healon5 OVD (Bacterially-Derived) | Mean Change in IOP From Baseline | Change in IOP from Baseline (mmHg) 1 week | 0.7 mmHg | Standard Deviation 3.3 |
| Investigational Healon5 OVD (Bacterially-Derived) | Mean Change in IOP From Baseline | Change in IOP from Baseline (mmHg) 3 months | -1.4 mmHg | Standard Deviation 2.6 |
| Investigational Healon5 OVD (Bacterially-Derived) | Mean Change in IOP From Baseline | Change in IOP from Baseline (mmHg) at 6 hours | 5.8 mmHg | Standard Deviation 6.9 |
| Approved Healon5 OVD (Animal-Derived) | Mean Change in IOP From Baseline | Change in IOP from Baseline (mmHg) 3 months | -1.3 mmHg | Standard Deviation 2.8 |
| Approved Healon5 OVD (Animal-Derived) | Mean Change in IOP From Baseline | Change in IOP from Baseline (mmHg) at 6 hours | 5.2 mmHg | Standard Deviation 5.9 |
| Approved Healon5 OVD (Animal-Derived) | Mean Change in IOP From Baseline | Change in IOP from Baseline (mmHg) at 1 day | 3.6 mmHg | Standard Deviation 4.9 |
| Approved Healon5 OVD (Animal-Derived) | Mean Change in IOP From Baseline | Change in IOP from Baseline (mmHg) 1 week | 0.9 mmHg | Standard Deviation 3.5 |
| Approved Healon5 OVD (Animal-Derived) | Mean Change in IOP From Baseline | Change in IOP from Baseline (mmHg) 1 month | -0.6 mmHg | Standard Deviation 2.8 |
Secondary
Ocular Serious Adverse Events (SAE)
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
Population: The results are consist of all subjects who had any study OVD used and with data available at the time of analysis.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Investigational Healon5 OVD (Bacterially-Derived) | Ocular Serious Adverse Events (SAE) | Total eyes with no SAEs | 190 Eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Ocular Serious Adverse Events (SAE) | Wound leak | 0 Eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Ocular Serious Adverse Events (SAE) | Conjunctival Laceration | 0 Eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Ocular Serious Adverse Events (SAE) | Cystoid macular edema | 0 Eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Ocular Serious Adverse Events (SAE) | Elevated IOP/IOP spike (30 mmHg or greater)* | 18 Eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Ocular Serious Adverse Events (SAE) | IOP spike <30 mmHg, requiring treatment* | 0 Eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Ocular Serious Adverse Events (SAE) | Keratitis secondary to Sjogren's | 1 Eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Ocular Serious Adverse Events (SAE) | Mild TASS | 1 Eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Ocular Serious Adverse Events (SAE) | Proliferative Diabetic Retinopathy | 1 Eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Ocular Serious Adverse Events (SAE) | Mild inflammation secondary to gout | 0 Eyes |
| Approved Healon5 OVD (Animal-Derived) | Ocular Serious Adverse Events (SAE) | Wound leak | 1 Eyes |
| Approved Healon5 OVD (Animal-Derived) | Ocular Serious Adverse Events (SAE) | Keratitis secondary to Sjogren's | 0 Eyes |
| Approved Healon5 OVD (Animal-Derived) | Ocular Serious Adverse Events (SAE) | Total eyes with no SAEs | 189 Eyes |
| Approved Healon5 OVD (Animal-Derived) | Ocular Serious Adverse Events (SAE) | Conjunctival Laceration | 1 Eyes |
| Approved Healon5 OVD (Animal-Derived) | Ocular Serious Adverse Events (SAE) | Mild TASS | 1 Eyes |
| Approved Healon5 OVD (Animal-Derived) | Ocular Serious Adverse Events (SAE) | Cystoid macular edema | 1 Eyes |
| Approved Healon5 OVD (Animal-Derived) | Ocular Serious Adverse Events (SAE) | Mild inflammation secondary to gout | 1 Eyes |
| Approved Healon5 OVD (Animal-Derived) | Ocular Serious Adverse Events (SAE) | Elevated IOP/IOP spike (30 mmHg or greater)* | 13 Eyes |
| Approved Healon5 OVD (Animal-Derived) | Ocular Serious Adverse Events (SAE) | Proliferative Diabetic Retinopathy | 0 Eyes |
| Approved Healon5 OVD (Animal-Derived) | Ocular Serious Adverse Events (SAE) | IOP spike <30 mmHg, requiring treatment* | 3 Eyes |
Secondary
Rate of IOP Spikes 30 mmHg or Greater at 3 Month Postoperatively
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
Population: Results are based on paired-eye subjects included in the safety population.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Investigational Healon5 OVD (Bacterially-Derived) | Rate of IOP Spikes 30 mmHg or Greater at 3 Month Postoperatively | 1 Day | 4 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Rate of IOP Spikes 30 mmHg or Greater at 3 Month Postoperatively | 1 Month | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Rate of IOP Spikes 30 mmHg or Greater at 3 Month Postoperatively | 1 Week | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Rate of IOP Spikes 30 mmHg or Greater at 3 Month Postoperatively | 3 Months | 0 eyes |
| Investigational Healon5 OVD (Bacterially-Derived) | Rate of IOP Spikes 30 mmHg or Greater at 3 Month Postoperatively | 6 Hours | 16 eyes |
| Approved Healon5 OVD (Animal-Derived) | Rate of IOP Spikes 30 mmHg or Greater at 3 Month Postoperatively | 3 Months | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Rate of IOP Spikes 30 mmHg or Greater at 3 Month Postoperatively | 6 Hours | 9 eyes |
| Approved Healon5 OVD (Animal-Derived) | Rate of IOP Spikes 30 mmHg or Greater at 3 Month Postoperatively | 1 Day | 5 eyes |
| Approved Healon5 OVD (Animal-Derived) | Rate of IOP Spikes 30 mmHg or Greater at 3 Month Postoperatively | 1 Week | 0 eyes |
| Approved Healon5 OVD (Animal-Derived) | Rate of IOP Spikes 30 mmHg or Greater at 3 Month Postoperatively | 1 Month | 0 eyes |