Evaluation of Investigational (Frequent Replacement) FRP Lens for Daily Wear

NCT02362724 | Completed Results FDA Device

• 1 other identifier: FC131202
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of the study is to compare the investigational contact lens to a marketed contact lens. The study results were not used for design validation of investigational contact lens,

Conditions

Ametropia

Outcome Measures

Primary Outcomes (16)

• Slit Lamp Findings for Epithelial Edema

  Slit Lamp Findings for Epithelial Edema on a grade of 0-4 (0 NONE: 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 (After lens dispensing)

• Slit Lamp Findings for Epithelial Edema

  Slit Lamp Findings for Epithelial Edema on a grade of 0-4 (0 NONE: 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)

  1 Month

• Slit Lamp Findings for Stromal Edema

  Slit Lamp Findings for Stromal Edema on a grade of 0-4 (0 NONE: No edema, 1 TRACE: Just detectable clouding, 2 MILD: Faint corneal striae (2 or fewer), 3 MODERATE: Pronounced corneal striae (3), 4 SEVERE: Folds in Descemet's membrane and \>4 pronounced striae)

  Baseline (After lens dispensing)

• Slit Lamp Findings for Stromal Edema

  Slit Lamp Findings for Stromal Edema on a grade of 0-4 (0 NONE: No edema, 1 TRACE: Just detectable clouding, 2 MILD: Faint corneal striae (2 or fewer), 3 MODERATE: Pronounced corneal striae (3), 4 SEVERE: Folds in Descemet's membrane and \>4 pronounced striae)

  1 month

• Slit Lamp Findings for Corneal Infiltrates

  Slit Lamp Findings for Corneal Infiltrates - Present, Absent

  Baseline (After lens dispensing)

• Slit Lamp Findings for Corneal Infiltrates

  Slit Lamp Findings for Corneal Infiltrates - Present, Absent

  1 Month

• Slit Lamp Findings for Corneal Vascularization

  Slit Lamp Findings for Corneal Vascularization on a grade 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)

  Baseline (After lens dispensing)

• Slit Lamp Findings for Corneal Vascularization

  Slit Lamp Findings for Corneal Vascularization on a grade 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)

  1 month

• Slit Lamp Findings for Limbal Hyperemia

  Slit Lamp Findings for Limbal Hyperemia on a grade 0-4 (0 NONE: No hyperemia present, 1 TRACE: Slight regional hyperemia, 2 MILD: Diffuse hyperemia, 3 MODERATE: Marked regional or diffuse hyperemia, 4 SEVERE: Diffuse episcleral or scleral hyperemia)

  Baseline (After lens dispensing)

• Slit Lamp Findings for Limbal Hyperemia

  Slit Lamp Findings for Limbal Hyperemia on a grade 0-4 (0 NONE: No hyperemia present, 1 TRACE: Slight regional hyperemia, 2 MILD: Diffuse hyperemia, 3 MODERATE: Marked regional or diffuse hyperemia, 4 SEVERE: Diffuse episcleral or scleral hyperemia)

  1 month

• Slit Lamp Findings for Bulbar Hyperemia

  Slit Lamp Findings for Bulbar Hyperemia on a grade 0-4 (0 NONE: No hyperemia present, 1 TRACE: Slight regional hyperemia, 2 MILD: Diffuse hyperemia, 3 MODERATE: Marked regional or diffuse hyperemia, 4 SEVERE: Diffuse episcleral or scleral hyperemia)

  Baseline (After lens dispensing)

• Slit Lamp Findings for Bulbar Hyperemia

  Slit Lamp Findings for Bulbar Hyperemia on a grade 0-4 (0 NONE: No hyperemia present, 1 TRACE: Slight regional hyperemia, 2 MILD: Diffuse hyperemia, 3 MODERATE: Marked regional or diffuse hyperemia, 4 SEVERE: Diffuse episcleral or scleral hyperemia)

  1 month

• Slit Lamp Findings for Palpebral Conjunctiva

  Slit Lamp Findings for Palpebral Conjunctiva - Present, Absent

  Baseline (After lens dispensing)

• Slit Lamp Findings for Palpebral Conjunctiva

  Slit Lamp Findings for Palpebral Conjunctiva - Present, Absent

  1 month

• Slit Lamp Findings for Other Findings

  Slit Lamp Findings for Other findings (conjunctival infection, corneal ulcers, iritis, lens adhesions and recurrent erosion) on a grade 0-4 (0 NONE, 1 TRACE, 2 MILD, 3 MODERATE, 4 SEVERE)

  Baseline (After lens dispensing)

• Slit Lamp Findings for Other Findings

  Slit Lamp Findings for Other findings (conjunctival infection, corneal ulcers, iritis, lens adhesions and recurrent erosion) on a grade 0-4 (0 NONE, 1 TRACE, 2 MILD, 3 MODERATE, 4 SEVERE)

  1 month

Study Arms (2)

Sapphire

EXPERIMENTAL

Subjects randomized to the experimental contact lens over the study duration

Device: Sapphire

Pearl

ACTIVE COMPARATOR

Subjects randomized to the active comparator contact lens over the study duration

Device: Pearl

Interventions

Sapphire DEVICE

silicone hydrogel contact lens

Sapphire

Pearl DEVICE

silicone hydrogel contact lens

Pearl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prior to being considered eligible to participate in this study, each subject MUST:
• Be at least 18 years of age as of the date of evaluation for the study.
• Have:
• Read the Informed Consent
• been given an explanation of the Informed Consent
• indicated understanding of the Informed Consent
• signed the Informed Consent document.
• Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments.
• Be an adapted, 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.
• Require spectacle lens powers between -0.50 and -8.00 diopters sphere with no more than 1.50 diopter of refractive astigmatism and be willing to wear contact lenses in both eyes.
• Have manifest refraction Snellen visual acuities (VA) equal to or better than 20/25 in each eye.
• To be eligible for lens dispensing, the subject must achieve 20/30 VA or better in each eye with the study lens and the investigator must judge the fit as acceptable or optimal.

You may not qualify if:

• Subjects may not be enrolled in this study if any of the following apply: The subject is currently or has:
• 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 or of the investigational office staff.
• Has a known sensitivity to the ingredients used in the MPS approved for use in the study and is unable or unwilling to use the alternate care system.
• Previous refractive surgery; or current or previous orthokeratology treatment.
• Is aphakic or psuedophakic.
• 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.
• The presence of clinically significant (grade 2, 3 or 4) anterior segment abnormalities; or the presence of any inflammations such as iritis; or any infection of the eye, lids, or associated structures.
• 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.
• Slit lamp findings that would contraindicate contact lens wear, including but not limited to:

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (6)

Eric M White OD, Inc.

San Diego, California, 92123, United States

Location

Office of Mark E Nakano, O.D.

Torrance, California, 90503, United States

Location

Advanced Family Eye Care

Denver, North Carolina, 28037, United States

Location

Quinn Foster & Associates

Athens, Ohio, 45701, United States

Location

Primary Eyecare Group, P.C.

Brentwood, Tennessee, 37027, United States

Location

Premier Vision Services, LLC

Amarillo, Texas, 79119, United States

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Myhanh Nguyen
• Organization: CooperVision, Inc.

mnguyen@coopervision.com

925-730-6716

Study Officials

• Steven L Saltzman, MD, FACOG

  Sterling IRB

  STUDY CHAIR

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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2015
• First Posted: February 13, 2015
• Study Start: February 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 14, 2020
• Results First Posted: September 24, 2020

Record last verified: 2015-12

Locations

US (6)