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

Ametropia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02362724
• Other study ID #: FC131202
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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,

Description:

The objective of this evaluation is to provide evidence supporting the claim that the performance of the Test Lens is substantially equivalent to that of the Control Lens when used in a one month (up to 30 days) recommended replacement, daily wear modality.

The study results were not used for design validation of investigational contact lens,

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Prior to being considered eligible to participate in this study, each subject MUST:

1. Be at least 18 years of age as of the date of evaluation for the study.

2. Have:

1. Read the Informed Consent

2. been given an explanation of the Informed Consent

3. indicated understanding of the Informed Consent

4. signed the Informed Consent document.

3. Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments.

4. 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.

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.

7. 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.

8. Have manifest refraction Snellen visual acuities (VA) equal to or better than 20/25 in each eye.

9. 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.

Exclusion Criteria:

• Subjects may not be enrolled in this study if any of the following apply: The subject is currently or has:

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 or of the investigational office staff.

6. 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.

7. Previous refractive surgery; or current or previous orthokeratology treatment.

8. Is aphakic or psuedophakic.

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. 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.

12. A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, iritis, bacterial or fungal infections.

13. A history of papillary conjunctivitis that has interfered with contact lens wear.

14. Slit lamp findings that would contraindicate contact lens wear, including but not limited to:

• Pathological dry eye or associated dry eye symptoms with decreased tear levels and punctuate staining > Grade 2

• Pterygium

• Corneal scars within the visual axis

• Neovascularization or ghost vessels > 1.0 mm in from the limbus

• Giant papillary conjunctivitis (GPC) of > Grade 2

• Anterior uveitis or iritis

• Seborrheic eczema, seborrheic conjunctivitis or blepharitis

Related Conditions & MeSH terms

• Ametropia
• Refractive Errors

Intervention

Device:
• Sapphire
silicone hydrogel contact lens
• Pearl
silicone hydrogel contact lens

Locations

Country	Name	City	State
United States	Premier Vision Services, LLC	Amarillo	Texas
United States	Quinn Foster & Associates	Athens	Ohio
United States	Primary Eyecare Group, P.C.	Brentwood	Tennessee
United States	Advanced Family Eye Care	Denver	North Carolina
United States	Eric M White OD, Inc.	San Diego	California
United States	Office of Mark E Nakano, O.D.	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	Slit Lamp Findings for Corneal Infiltrates	Slit Lamp Findings for Corneal Infiltrates - Present, Absent	Baseline (After lens dispensing)
Primary	Slit Lamp Findings for Corneal Infiltrates	Slit Lamp Findings for Corneal Infiltrates - Present, Absent	1 Month
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	Slit Lamp Findings for Palpebral Conjunctiva	Slit Lamp Findings for Palpebral Conjunctiva - Present, Absent	Baseline (After lens dispensing)
Primary	Slit Lamp Findings for Palpebral Conjunctiva	Slit Lamp Findings for Palpebral Conjunctiva - Present, Absent	1 month
Primary	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)
Primary	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