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

Primary Purpose

Myopia, Hyperopia, Astigmatism

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Invigor A (test)

Invigor B (control)

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:
1. Be at least 18 years of age as of the date of evaluation for the study
2. Have
  1. Read the informed consent document
  2. Been given an explanation of the informed consent document
  3. indicated understanding of the informed consent document
  4. Signed the informed consent document
3. Be willing and able to adhere to the instructions provided by the investigational site and be willing to keep all specified appointments.
4. 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.
5. Possess or obtain prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses.
6. Be in good general health, based on his/her knowledge.
Exclusion Criteria:
1. 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.
2. Poor personal hygiene.
3. Any active participation in another clinical trial during this trial or within 30 days prior to this study.
4. To the best of the subject's knowledge, she is currently pregnant, is lactating or is planning a pregnancy within the next 3 months.
5. A member, relative or household member of the investigator(s) or of the investigational office staff.
6. 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.
7. Had previous refractive surgery; or current or previous orthokeratology treatment.
8. Aphakic or pseudophakic.
9. 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.
10. 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.
11. A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, iritis, bacterial or fungal infections.
12. A history of papillary conjunctivitis that has interfered with contact lens wear.

Sites / Locations

Mark Nakano. O.D
Vision Care Associates
The Koetting Associates
Quinn, Foster & Associates
Primary Eyecare Group, P.C
Ziegler Leffingwell Eye Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Invigor A (test)

Invigor B (Control)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Number of Eyes With Epithelial Edema - Slit Lamp Findings

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

Number of Eyes With Stromal Edema - Slit Lamp Findings

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

Number of Eyes With Corneal Vascularization - Slit Lamp Findings

Number of Eyes With Corneal Staining - Slit Lamp Findings

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

Number of Eyes With Corneal Staining - Slit Lamp Findings

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

Number of Eyes With Corneal Infiltrates - Slit Lamp Findings

Corneal Infiltrates on slit lamp findings - Present / Absent

Number of Eyes With Corneal Infiltrates - Slit Lamp Findings

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

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).

Number of Eyes With Limbal Hyperemia - Slit Lamp Findings

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)

Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings

Number of Eyes With Palpebral Conjunctival Observations - Slit Lamp Findings

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

Number of Eyes With Palpebral Conjunctiva - Slit Lamp Findings

Palpebral Conjunctival Observations on slit lamp findings - Present / Absent

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)

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

Secondary Outcome Measures

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

Number of Eyes With Visual Acuity was assessed using Snellen VA Chart for an effective visual distance of 20 feet

Full Information

NCT ID

NCT03722784

First Posted

October 25, 2018

Last Updated

September 10, 2020

Sponsor

Coopervision, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03722784

Brief Title

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

Official Title

Evaluation of the CooperVision, Inc. Invigor A and Invigor B Silicone Hydrogel Daily Wear Contact Lenses When Used for Frequent Replacement for Up to One (1) Month of Daily Wear

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

October 10, 2018 (Actual)

Primary Completion Date

January 18, 2019 (Actual)

Study Completion Date

June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Coopervision, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This study is a multi-centered, daily wear, monthly replacement, bilateral, randomized in a ratio of two to one (2:1) Test to Control, lens blocked (subjects remain in the same lens brand throughout the study), licensed investigator and subject masked, concurrent controlled study with a study duration of approximately three months evaluating performance equivalence of Invigor A (test) over Invigor B (control) contact lenses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myopia, Hyperopia, Astigmatism

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

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.

Allocation

Randomized

Enrollment

88 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Invigor A (test)

Arm Type

Experimental

Arm Description

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

Arm Title

Invigor B (Control)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Invigor A (test)

Intervention Description

silicone hydrogel lens

Intervention Type

Device

Intervention Name(s)

Invigor B (control)

Intervention Description

silicone hydrogel lens

Primary Outcome Measure Information:

Title

Number of Eyes With Epithelial Edema - Slit Lamp Findings

Description

Time Frame

Baseline

Title

Number of Eyes With Epithelial Edema - Slit Lamp Findings

Description

Time Frame

One Month

Title

Number of Eyes With Stromal Edema - Slit Lamp Findings

Description

Time Frame

Baseline

Title

Number of Eyes With Stromal Edema - Slit Lamp Findings

Description

Time Frame

One Month

Title

Number of Eyes With Corneal Vascularization - Slit Lamp Findings

Description

Time Frame

Baseline

Title

Number of Eyes With Corneal Vascularization - Slit Lamp Findings

Description

Time Frame

One Month

Title

Number of Eyes With Corneal Staining - Slit Lamp Findings

Description

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

Time Frame

Baseline

Title

Number of Eyes With Corneal Staining - Slit Lamp Findings

Description

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

Time Frame

One Month

Title

Number of Eyes With Corneal Infiltrates - Slit Lamp Findings

Description

Corneal Infiltrates on slit lamp findings - Present / Absent

Time Frame

Baseline

Title

Number of Eyes With Corneal Infiltrates - Slit Lamp Findings

Description

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

Time Frame

One Month

Title

Number of Eyes With Limbal Hyperemia - Slit Lamp Findings

Description

Time Frame

Baseline

Title

Number of Eyes With Limbal Hyperemia - Slit Lamp Findings

Description

Time Frame

One Month

Title

Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings

Description

Time Frame

Baseline

Title

Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings

Description

Time Frame

One Month

Title

Number of Eyes With Palpebral Conjunctival Observations - Slit Lamp Findings

Description

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

Time Frame

Baseline

Title

Number of Eyes With Palpebral Conjunctiva - Slit Lamp Findings

Description

Palpebral Conjunctival Observations on slit lamp findings - Present / Absent

Time Frame

One Month

Title

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

Description

Time Frame

Baseline

Title

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

Description

Time Frame

One Month

Secondary Outcome Measure Information:

Title

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

Description

Number of Eyes With Visual Acuity was assessed using Snellen VA Chart for an effective visual distance of 20 feet

Time Frame

One Month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials: