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Completed

NCT Number: NCT03722784

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

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.

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Key information

Conditions

Myopia Astigmatism Eye Diseases Hyperopia Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mark Nakano. O.D, Torrance, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Invigor A (test)

Device

silicone hydrogel lens

Invigor B (control)

Device

silicone hydrogel lens

Primary outcomes

  1. Number of Eyes With Epithelial Edema - Slit Lamp Findings

    Time frame: Baseline

    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)

  2. Number of Eyes With Epithelial Edema - Slit Lamp Findings

    Time frame: One Month

    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)

  3. Number of Eyes With Stromal Edema - Slit Lamp Findings

    Time frame: Baseline

    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

  4. Number of Eyes With Stromal Edema - Slit Lamp Findings

    Time frame: One Month

    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

  5. Number of Eyes With Corneal Vascularization - Slit Lamp Findings

    Time frame: Baseline

    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

  6. Number of Eyes With Corneal Vascularization - Slit Lamp Findings

    Time frame: One Month

    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

  7. Number of Eyes With Corneal Staining - Slit Lamp Findings

    Time frame: Baseline

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

  8. Number of Eyes With Corneal Staining - Slit Lamp Findings

    Time frame: One Month

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

  9. Number of Eyes With Corneal Infiltrates - Slit Lamp Findings

    Time frame: Baseline

    Corneal Infiltrates on slit lamp findings - Present / Absent

  10. Number of Eyes With Corneal Infiltrates - Slit Lamp Findings

    Time frame: One Month

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

  11. Number of Eyes With Limbal Hyperemia - Slit Lamp Findings

    Time frame: Baseline

    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).

  12. Number of Eyes With Limbal Hyperemia - Slit Lamp Findings

    Time frame: One Month

    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).

  13. Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings

    Time frame: Baseline

    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)

  14. Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings

    Time frame: One Month

    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)

  15. Number of Eyes With Palpebral Conjunctival Observations - Slit Lamp Findings

    Time frame: Baseline

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

  16. Number of Eyes With Palpebral Conjunctiva - Slit Lamp Findings

    Time frame: One Month

    Palpebral Conjunctival Observations on slit lamp findings - Present / Absent

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

    Time frame: Baseline

    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)

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

    Time frame: One Month

    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)

Secondary outcomes

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

    Time frame: One Month

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

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 29, 2018
Registry last updated
Oct 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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