Evaluation of Silicone Hydrogel Daily Wear Contact Lenses for Up to One (1) Month of Daily Wear

NCT03722784 | Completed Results FDA Device

• 1 other identifier: FC160322
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 6

Brief Summary

The aim of the study is to evaluate if the performance of Invigor A is substantially equivalent to Invigor B contact lenses when used in a one month recommended replacement, daily wear modality.

Conditions

Myopia; Hyperopia; Astigmatism

Outcome Measures

Primary Outcomes (18)

• Number of Eyes With Epithelial Edema - Slit Lamp Findings

  Epithelial edema on slit lamp grading scale 0 - 4 (0- No microcysts; normal transparency, 1 Trace - 1 to 20 microcysts; barely discernible local epithelial haziness, 2 Mild - 21 to 50 microcysts; faint but definite localized or generalized haziness, 3 Moderate - 51 to 100 microcysts; significant localized or generalized haziness, 4 Severe - \>100 microcysts; definite widespread epithelial cloudiness giving a dull glass appearance to the cornea, or numerous coalescing bullae)

  Baseline

• Number of Eyes With Epithelial Edema - Slit Lamp Findings

  Epithelial edema on slit lamp grading scale 0 - 4 (0- No microcysts; normal transparency, 1 Trace - 1 to 20 microcysts; barely discernible local epithelial haziness, 2 Mild - 21 to 50 microcysts; faint but definite localized or generalized haziness, 3 Moderate - 51 to 100 microcysts; significant localized or generalized haziness, 4 Severe - \>100 microcysts; definite widespread epithelial cloudiness giving a dull glass appearance to the cornea, or numerous coalescing bullae)

  One Month

• Number of Eyes With Stromal Edema - Slit Lamp Findings

  Stromal edema on slit lamp grading scale 0-4 (0 None - No edema, 1 Trace - Just detectable clouding, 2 Mild - faint corneal striae, 3 Moderate - Pronounced corneal striae, 4 severe - folds in Descemet's membrane and ≥4 pronounced striae

  Baseline

• Number of Eyes With Stromal Edema - Slit Lamp Findings

  Stromal edema on slit lamp grading scale 0-4 (0 None - No edema, 1 Trace - Just detectable clouding, 2 Mild - faint corneal striae, 3 Moderate - Pronounced corneal striae, 4 severe - folds in Descemet's membrane and ≥4 pronounced striae

  One Month

• Number of Eyes With Corneal Vascularization - Slit Lamp Findings

  Corneal Vascularization on slit lamp grading scale 0-4 (0 None: No vessel penetration, 1 Trace: \<1.00 mm vessel penetration, 2 Mild: \>1.00 mm to \<1.50 mm vessel penetration, 3 Moderate: \>1.50 mm to \<2.00 mm vessel penetration, 4 Severe: Vessel penetration \>2.00 mm) Depth: a. - Epithelial b. - Anterior Stromal c. - Mid/Posterior Stromal Location: N - Nasal T - Temporal I - Inferior S - Superior

  Baseline

• Number of Eyes With Corneal Vascularization - Slit Lamp Findings

  Corneal Vascularization on slit lamp grading scale 0-4 (0 None: No vessel penetration, 1 Trace: \<1.00 mm vessel penetration, 2 Mild: \>1.00 mm to \<1.50 mm vessel penetration, 3 Moderate: \>1.50 mm to \<2.00 mm vessel penetration, 4 Severe: Vessel penetration \>2.00 mm) Depth: a. - Epithelial b. - Anterior Stromal c. - Mid/Posterior Stromal Location: N - Nasal T - Temporal I - Inferior S - Superior

  One Month

• Number of Eyes With Corneal Staining - Slit Lamp Findings

  Corneal Staining with fluorescent on slit lamp findings - Present / Absent

  Baseline

• Number of Eyes With Corneal Staining - Slit Lamp Findings

  Corneal Staining with fluorescent on slit lamp findings - Present / Absent

  One Month

• Number of Eyes With Corneal Infiltrates - Slit Lamp Findings

  Corneal Infiltrates on slit lamp findings - Present / Absent

  Baseline

• Number of Eyes With Corneal Infiltrates - Slit Lamp Findings

  Number of Eyes With Corneal Infiltrates on slit lamp findings - Present / Absent

  One Month

• Number of Eyes With Limbal Hyperemia - Slit Lamp Findings

  Limbal Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight limbal hyperemia (mild segmented), 2 Mild: Mild limbal hyperemia (mild circumcorneal), 3 Moderate: Significant limbal hyperemia (marked segmented), 4 Severe: Severe limbal hyperemia (marked circumcorneal).

  Baseline

• Number of Eyes With Limbal Hyperemia - Slit Lamp Findings

  Limbal Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight limbal hyperemia (mild segmented), 2 Mild: Mild limbal hyperemia (mild circumcorneal), 3 Moderate: Significant limbal hyperemia (marked segmented), 4 Severe: Severe limbal hyperemia (marked circumcorneal).

  One Month

• Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings

  Bulbar Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight regional hyperemia, 2 Mild: Diffuse hyperemia, 3 Moderate: Marked regional or diffuse hyperemia, 4 Severe: Diffuse episcleral or scleral hyperemia)

  Baseline

• Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings

  Bulbar Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight regional hyperemia, 2 Mild: Diffuse hyperemia, 3 Moderate: Marked regional or diffuse hyperemia, 4 Severe: Diffuse episcleral or scleral hyperemia)

  One Month

• Number of Eyes With Palpebral Conjunctival Observations - Slit Lamp Findings

  Number of Eyes With Palpebral Conjunctival Observations on slit lamp findings - Present / Absent

  Baseline

• Number of Eyes With Palpebral Conjunctiva - Slit Lamp Findings

  Palpebral Conjunctival Observations on slit lamp findings - Present / Absent

  One Month

• Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings

  Clinical entities such as conjunctival infection, epidemic keratoconjunctivitis, corneal ulcers, iritis, lens adhesions and recurrent erosion on Slit lamp grading scale of 0-4 (0 None 1 Trace, 2 Mild, 3 Moderate, 4 Severe)

  Baseline

• Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings

  Clinical entities such as conjunctival infection, epidemic keratoconjunctivitis, corneal ulcers, iritis, lens adhesions and recurrent erosion on Slit lamp grading scale of 0-4 (0 None 1 Trace, 2 Mild, 3 Moderate, 4 Severe)

  One Month

Secondary Outcomes (1)

• Number of Eyes With Visual Acuity for an Effective Visual Distance of 20 Feet

  One Month

Study Arms (2)

Invigor A (test)

EXPERIMENTAL

Subjects will be randomized to wear Invigor A (test) for one month of daily wear during the study.

Device: Invigor A (test)

Invigor B (Control)

ACTIVE COMPARATOR

Subjects will be randomized to wear Invigor B (Control) for one month of daily wear during the study.

Device: Invigor B (control)

Interventions

Invigor A (test) DEVICE

silicone hydrogel lens

Invigor A (test)

Invigor B (control) DEVICE

silicone hydrogel lens

Invigor B (Control)

Eligibility Criteria

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

You may qualify if:

• Be at least 18 years of age as of the date of evaluation for the study
• Have
• Read the informed consent document
• Been given an explanation of the informed consent document
• indicated understanding of the informed consent document
• Signed the informed consent document
• Be willing and able to adhere to the instructions provided by the investigational site and be willing to keep all specified appointments.
• Be an adapted, frequent replacement, current full - time silicone hydrogel or soft contact lens wearer. An adapted full- time wearer is defined as wearing contact lenses at least 5 days per week for at least 8 hours per day for at least one month prior to participation in the study.
• Possess or obtain prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses.
• Be in good general health, based on his/her knowledge.

You may not qualify if:

• Wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes for the duration of the study. Note: Subjects may not wear lenses in a monovision modality at any time during the study as it will interfere with the visual acuity analysis.
• Poor personal hygiene.
• Any active participation in another clinical trial during this trial or within 30 days prior to this study.
• To the best of the subject's knowledge, she is currently pregnant, is lactating or is planning a pregnancy within the next 3 months.
• A member, relative or household member of the investigator(s) or of the investigational office staff.
• A known sensitivity to the ingredients used in the multi-purpose solution approved for use in the study and is unable or unwilling to use the alternate care system.
• Had previous refractive surgery; or current or previous orthokeratology treatment.
• Aphakic or pseudophakic.
• Ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, scleroderma, keratoconus or uncontrolled diabetes.
• The need for topical ocular medications or any systemic medication which might interfere with contact lens wear or require the lenses to be removed during the day.
• A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, iritis, bacterial or fungal infections.
• A history of papillary conjunctivitis that has interfered with contact lens wear.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (6)

Mark Nakano. O.D

Torrance, California, 90503, United States

Location

Vision Care Associates

East Lansing, Michigan, 48823, United States

Location

The Koetting Associates

St Louis, Missouri, 63144, United States

Location

Quinn, Foster & Associates

Athens, Ohio, 45701, United States

Location

Primary Eyecare Group, P.C

Brentwood, Tennessee, 37027-7552, United States

Location

Ziegler Leffingwell Eye Center

West Allis, Wisconsin, 53227, United States

Location

MeSH Terms

Conditions

Myopia; Hyperopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Martine Robie
• Organization: CooperVision, Inc.

mrobie@coopervision.com

9256604477

Study Officials

• Thomas Quinn, O.D

  Quinn, Foster & Associates, OH

  PRINCIPAL INVESTIGATOR

• Peter Van Hoven, O.D

  Primary Eyecare group, P.C, TN

  PRINCIPAL INVESTIGATOR

• Mark Nakano, O.D

  Mark Nakano, O.D, CA

  PRINCIPAL INVESTIGATOR

• David Ziegler, O.D

  Ziegler Leffingwell Eye Center, WI

  PRINCIPAL INVESTIGATOR

• Cheryl Vincent Riemer, O.D

  Vision Care Associates, MI

  PRINCIPAL INVESTIGATOR

• Carmen Castellano, O.D

  The Koetting Associates, MO

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The subject will know the name of the lens however they will not be aware of which lens is investigational and which lens has been previously cleared. The licensed investigator has not been informed which lens is the investigational lens.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: October 29, 2018
• Study Start: October 10, 2018
• Primary Completion: January 18, 2019
• Study Completion: June 1, 2019
• Last Updated: October 1, 2020
• Results First Posted: October 1, 2020

Record last verified: 2020-08

Locations

US (6)