Clinical trial NCT03722784: 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
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Hyperopia
Astigmatism
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2018-10-29
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: * 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.

Primary outcomes:
measure: Number of Eyes With Epithelial Edema - Slit Lamp Findings
timeFrame: Baseline
measure: Number of Eyes With Epithelial Edema - Slit Lamp Findings
timeFrame: One Month
measure: Number of Eyes With Stromal Edema - Slit Lamp Findings
timeFrame: Baseline
measure: Number of Eyes With Stromal Edema - Slit Lamp Findings
timeFrame: One Month
measure: Number of Eyes With Corneal Vascularization - Slit Lamp Findings
timeFrame: Baseline
measure: Number of Eyes With Corneal Vascularization - Slit Lamp Findings
timeFrame: One Month
measure: Number of Eyes With Corneal Staining - Slit Lamp Findings
timeFrame: Baseline
measure: Number of Eyes With Corneal Staining - Slit Lamp Findings
timeFrame: One Month
measure: Number of Eyes With Corneal Infiltrates - Slit Lamp Findings
timeFrame: Baseline
measure: Number of Eyes With Corneal Infiltrates - Slit Lamp Findings
timeFrame: One Month
measure: Number of Eyes With Limbal Hyperemia - Slit Lamp Findings
timeFrame: Baseline
measure: Number of Eyes With Limbal Hyperemia - Slit Lamp Findings
timeFrame: One Month
measure: Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings
timeFrame: Baseline
measure: Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings
timeFrame: One Month
measure: Number of Eyes With Palpebral Conjunctival Observations - Slit Lamp Findings
timeFrame: Baseline
measure: Number of Eyes With Palpebral Conjunctiva - Slit Lamp Findings
timeFrame: One Month
measure: Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings
timeFrame: Baseline
measure: Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings
timeFrame: One Month
Secondary outcomes:
measure: Number of Eyes With Visual Acuity for an Effective Visual Distance of 20 Feet
timeFrame: One Month
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Mark Nakano. O.D
state: California
city: East Lansing
country: United States
facility: Vision Care Associates
state: Michigan
city: Saint Louis
country: United States
facility: The Koetting Associates
state: Missouri
city: Athens
country: United States
facility: Quinn, Foster & Associates
state: Ohio
city: Brentwood
country: United States
facility: Primary Eyecare Group, P.C
state: Tennessee
city: West Allis
country: United States
facility: Ziegler Leffingwell Eye Center
state: Wisconsin
Study officials:
affiliation: Quinn, Foster & Associates, OH
name: Thomas Quinn, O.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Primary Eyecare group, P.C, TN
name: Peter Van Hoven, O.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Mark Nakano, O.D, CA
name: Mark Nakano, O.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Ziegler Leffingwell Eye Center, WI
name: David Ziegler, O.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Vision Care Associates, MI
name: Cheryl Vincent Riemer, O.D
role: PRINCIPAL_INVESTIGATOR
affiliation: The Koetting Associates, MO
name: Carmen Castellano, O.D
role: PRINCIPAL_INVESTIGATOR
References: