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Prospective, multicenter, paired-eye, randomized, masked, clinical trial of the bacterially-derived Healon5 OVD versus the currently available Healon5 OVD control.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Healon5 OVD | Experimental | Subjects to receive investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. |
|
| Approved Healon5 OVD | Active Comparator | Subjects to receive investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Healon5 OVD | Device | ophthalmic viscosurgical device |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | 3 months |
| 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%. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
| Mean Change in IOP From Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kendra Hileman, PhD | Abbott Medical Optics | Study Director |
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Serious adverse event or other adverse event data and other data as needed.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Investigational Healon5 OVD (Bacterially-Derived) | Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Investigational Healon5 OVD: ophthalmic viscosurgical device |
| FG001 | Approved Healon5 OVD (Animal-Derived) | Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Healon5 OVD: ophthalmic viscosurgical device |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
208 participants received both products, while 3 only received the Bacterially-Derived OVD and 2 only received the Animal-Derived OVD for a total of 213 paired-eye and non-paired eye subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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%. | 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. | Posted | Count of Participants | Participants | 3 months |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Investigational Healon5 OVD | Subjects to receive investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Investigational Healon5 OVD: ophthalmic viscosurgical device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated IOP/IOP Spike (30 mmHg or greater) | Eye disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Posterior capsule opacification | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kendra Hileman, Ph.D., Head of Clinical Sciences | Abbott Medical Optics, Inc. | 714-247-8613 | kendra.hileman@abbott.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 21, 2016 | Apr 12, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 22, 2016 | Apr 13, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Healon5 OVD |
| Device |
ophthalmic viscosurgical device |
|
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 months |
| 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. | 3 months |
| 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. | Upto 3 months |
| 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. | Upto 3 months |
| 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. | Upto 3 months |
| 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. | Upto 3 months |
| 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. | Upto 3 months |
| 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. | Upto 3 Months |
| 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. | Upto 3 Months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 |
| Approved Healon5 OVD (Animal-Derived) |
Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Healon5 OVD: ophthalmic viscosurgical device |
|
|
| 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%. | 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. | Posted | Mean | 95% Confidence Interval | percent change | 3 months |
|
|
|
| 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 | The results are consist of all subjects who had any study OVD used and with data available at the time of analysis. | Posted | Count of Units | Eyes | 3 months | Eyes | 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. | Results are based on paired-eye subjects included in the safety population. | Posted | Mean | Standard Deviation | mmHg | 3 months | eyes | 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. | Results are based on paired-eye subjects included in the safety population. | Posted | Count of Units | eyes | 3 months | eyes | 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. | 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. | Posted | Count of Units | eyes | Upto 3 months | eyes | 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. | 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. | Posted | Count of Units | eyes | Upto 3 months | eyes | 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. | 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. | Posted | Count of Units | eyes | Upto 3 months | eyes | 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. | 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. | Posted | Count of Units | eyes | Upto 3 months | eyes | eyes |
|
|
|
| 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. | 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. | Posted | Count of Units | eyes | Upto 3 months | eyes | 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. | 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. | Posted | Count of Units | eyes | Upto 3 Months | eyes | 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. | 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. | Posted | Count of Units | eyes | Upto 3 Months | eyes | eyes |
|
|
|
| 0 |
| 211 |
| 24 |
| 211 |
| 174 |
| 211 |
| EG001 | Approved Healon5 OVD | Subjects to receive investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Healon5 OVD: ophthalmic viscosurgical device | 0 | 210 | 24 | 210 | 173 | 210 |
| IOP spike <30 mmHg, requiring treatment | Eye disorders | Systematic Assessment |
|
| Conjunctival Laceration | Eye disorders | Systematic Assessment |
|
| Cystoid macular edema | Eye disorders | Systematic Assessment |
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| Keratitis secondary to Sjogren's | Eye disorders | Systematic Assessment |
|
| Mild TASS (toxic anterior segment syndrome) | Eye disorders | Systematic Assessment |
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| Proliferative Diabetic Retinopathy | Eye disorders | Systematic Assessment |
|
| wound leak | Eye disorders | Systematic Assessment |
|
| Mild inflammation secondary to gout | Eye disorders | Systematic Assessment |
|
| Hospitalization: tests and observation of possible transient ischemic attack and dementia | Vascular disorders | Non-systematic Assessment |
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| Melanoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Hospitalization: penumonia and flu | Immune system disorders | Non-systematic Assessment |
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| Blepharitis/meibomiantis | Eye disorders | Systematic Assessment |
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| dry eye/superficial punctate keratopathy/punctate epithelialerosion/tear film insufficiency | Eye disorders | Systematic Assessment |
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| Posterior vitreous detachment | Eye disorders | Systematic Assessment |
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| Elevated IOP/ocular hypertension | Eye disorders | Systematic Assessment |
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| Posterior capsule striae/wrinkles | Eye disorders | Systematic Assessment |
|
| Drusen | Eye disorders | Systematic Assessment |
|
| Dermatochalasis | Eye disorders | Systematic Assessment |
|
| Folds in Descemet's | Eye disorders | Systematic Assessment |
|
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.
| Elevated IOP/IOP spike (30 mmHg or greater)* |
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| IOP spike <30 mmHg, requiring treatment* |
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| Keratitis secondary to Sjogren's |
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| Mild TASS |
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| Proliferative Diabetic Retinopathy |
|
| Wound leak |
|
| Mild inflammation secondary to gout |
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| Total eyes with no SAEs |
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| Change in IOP from Baseline (mmHg) 1 week |
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| Change in IOP from Baseline (mmHg) 1 month |
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| Change in IOP from Baseline (mmHg) 3 months |
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| 1 Week |
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| 1 Month |
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| 3 Months |
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| Epithelial Edema at 1 Day |
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| Epithelial Edema at 1 Week |
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| Epithelial Edema at 1 Month |
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| Epithelial Edema at 3 Month |
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| Stromal Edema at 1 Day |
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| Stromal Edema at 1 Week |
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| Stromal Edema at 1 Month |
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| Stromal Edema at 3 Months |
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| Cells at 1 Day |
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| Cells at 1 Week |
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| Cells at 1 Month |
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| Cells at 3 Months |
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| Flares at 1 Day |
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| Flares at 1 Week |
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| Flares at 1 Month |
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| Flares at 6 Months |
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| Anterior Synechiae at 1 Day |
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| Anterior Synechiae at 1 Week |
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| Anterior Synechiae at 1 Month |
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| Anterior Synechiae at 3 Months |
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| Posterior Synechiae at 1 Day |
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| Posterior Synechiae at 1 Week |
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| Posterior Synechiae at 1 Month |
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| Posterior Synechiae 3 Months |
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| Fibrin Presence at 1 Day |
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| Fibrin Presence at 1 Week |
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| Fibrin Presence at 1 Month |
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| Fibrin Presence at 3 Months |
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| Mild (+2) |
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| Moderate (+3) |
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| Severe (+4) |
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| Mild (+2) |
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| Moderate (+3) |
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| Severe (+4) |
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| Mild (+2) |
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| Moderate (+3) |
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| Severe (+4) |
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| Mild (+2) |
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| Moderate (+3) |
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| Severe (+4) |
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| Mild (+2) |
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| Moderate (+3) |
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| Severe (+4) |
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| Mild (+2) |
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| Moderate (+3) |
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| Severe (+4) |
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| Mild (+2) |
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| Moderate (+3) |
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| Severe (+4) |
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| Mild (+2) |
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| Moderate (+3) |
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| Severe (+4) |
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| Trace (1+) |
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| Mild (2+) |
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| Moderate (3+) |
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| Severe (4+) |
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| Trace (1+) |
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| Mild (2+) |
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| Moderate (3+) |
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| Severe (4+) |
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| Trace (1+) |
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| Mild (2+) |
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| Moderate (3+) |
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| Severe (4+) |
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| Trace (1+) |
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| Mild (2+) |
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| Moderate (3+) |
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| Severe (4+) |
|
| Moderate (2+) |
|
| Moderate (2+) |
|
| Moderate (2+) |
|
| Moderate (2+) |
|
| Mild (+2) |
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| Mild (+2) |
|
| Mild (+2) |
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| Mild (+2) |
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| Mild (+2) |
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| Mild (+2) |
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| Mild (+2) |
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| Mild (+2) |
|