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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cataract

Intervention / Treatment
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* Device: Investigational Healon5 OVD
* Device: Healon5 OVD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Healon5 OVD<br>Subjects to receive investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. | Device: Investigational Healon5 OVD<br>* ophthalmic viscosurgical device<br>|
| Active Comparator: Approved Healon5 OVD<br>Subjects to receive investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. | Device: Healon5 OVD<br>* ophthalmic viscosurgical device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |