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

NCT02782676 | Completed Results DMC FDA Device

• 1 other identifier: VSCO-109-HLN5
• Study Type: interventional
• Target: 241
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Cataract

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Ocular Serious Adverse Events (SAE)

  3 months

• Mean Change in IOP From Baseline

  3 months

• Rate of IOP Spikes 30 mmHg or Greater at 3 Month Postoperatively

  3 months

• Grade of Inflammation: Epithelial Edema

  Upto 3 months

• Grade of Inflammation: Stromal Edema

  Upto 3 months

Study Arms (2)

Investigational Healon5 OVD

EXPERIMENTAL

Subjects to receive investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.

Device: Investigational Healon5 OVD

Approved Healon5 OVD

ACTIVE COMPARATOR

Subjects to receive investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.

Device: Healon5 OVD

Interventions

Investigational Healon5 OVD DEVICE

ophthalmic viscosurgical device

Investigational Healon5 OVD

Healon5 OVD DEVICE

ophthalmic viscosurgical device

Approved Healon5 OVD

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Optics: lead

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Kendra Hileman, Ph.D., Head of Clinical Sciences
• Organization: Abbott Medical Optics, Inc.

kendra.hileman@abbott.com

714-247-8613

Study Officials

• Kendra Hileman, PhD

  Abbott Medical Optics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: May 25, 2016
• Study Start: June 21, 2016
• Primary Completion: May 4, 2017
• Study Completion: May 4, 2017
• Last Updated: February 4, 2025
• Results First Posted: May 24, 2018

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share