One Week Assessment of a New Study Test Lens

Myopia Clinical Trial

Official title:

One Week Assessment of a New Study Test Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02642341
• Other study ID #: CV-15-74-MTF
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: March 2016

Study information

• Verified date: July 2020
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will investigate performance criteria over one week of daily wear to determine if the comfilcon A asphere lens (test) performs equivalently to the comfilcon A sphere (control) in terms of measurement and subjective ratings of visual performance.

Both comfilcon A asphere lens (test) and comfilcon A sphere (control) are Coopervision lenses.

Description:

This study is a prospective, single site, daily wear, double masked, randomized bilateral cross over dispensing study of binocular wear of comfilcon A asphere lens (test) and comfilcon A sphere lens (control) over 1 week of daily wear. Assessments will be obtained upon dispensing each lens pair and following 1 week of daily lens use.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

• Oculo-visual examination in the last two years

• Between 18 and 35 years of age and has full legal capacity to volunteer

• Has read and understood the informed consent letter

• Is willing and able to follow instructions and maintain the appointment schedule

• Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected

• Currently wears, or has previously successfully worn, soft contact lenses between -1.00D (Diopter) and -4.00D

• Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder <-0.75

• Has not worn lenses for at least 12 hours before the initial visit

• Has a subjective response at baseline, which indicates suitability for this study

• Currently spends a minimum of 4 hours a day; 5 days a week on digital devices and can replicate this time during the study period

• Is willing and able to wear the study contact lenses a minimum of 10 hours per day; 5 days a week.

Exclusion Criteria:

A person will be excluded from the study if he/she:

• Has never worn contact lenses before

• Any systemic disease affecting ocular health

• Is using any systemic or topical medications that will affect ocular health

• Has known sensitivity to the diagnostic pharmaceuticals or study products used in this study.

• Has any ocular pathology or anomaly that would affect the wearing of the lenses

• Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye

• Is aphakic

• Has anisometropia of >1.00

• Has undergone corneal refractive surgery

• Has strabismus

• Has any ocular amblyopia >= 1line of HC (High Contrast) Visual Acuity

• Is participating in any other type of eye related clinical or research study

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• comfilcon A asphere lens (test)
contact lens
• comfilcon A sphere lens (control)
contact lens

Locations

Country	Name	City	State
United States	CORL, Indiana University School of Optometry	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance Visual Acuity (VA) - High Contrast (HC) - Study Test Lens	logMAR (Logarithm of the Minimum Angle of Resolution) VA (Visual Acuity)	Up to 1 week
Primary	Distance Visual Acuity (VA) - High Contrast (HC) - comfilcon A	logMAR VA	Up to 1 week
Primary	Near Visual Acuity (VA) - High Contrast (HC) - Study Test Lens	logMAR VA	Up to 1 week
Primary	Near Visual Acuity (VA) - High Contrast (HC) - comfilcon A	logMAR VA	Up to 1 week
Primary	Distance Visual Acuity (VA) - Low Contrast (LC) - Study Test Lens	logMAR VA	Up to 1 week
Primary	Distance Visual Acuity (VA) - Low Contrast (LC) - comfilcon A	logMAR VA	Up to 1 week
Primary	Near Visual Acuity (VA) - Low Contrast (LC) - Study Test Lens	logMAR VA	Up to 1 week
Primary	Near Visual Acuity (VA) - Low Contrast (LC) - comfilcon A	logMAR VA	Up to 1 week
Primary	Quality of Vision - Distance	Quality of Vision - distance for test lens and comfilcon A control lens is assessed. subjective scoring using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time	Up to 1 week
Primary	Quality of Vision - Near	Quality of Vision - near for test lens and comfilcon A control lens is assessed. Subjective scoring using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time	Up to 1 week
Primary	High Illumination High Contrast (HIHC) Visual Acuity	High Illumination High Contrast (HICH) Visual Acuity assessed for test lens and comfilcon A control lens using logMAR VA	Up to 1 week
Primary	Low Illumination High Contrast (LIHC) Visual Acuity	Low Illumination High Contrast (LIHC) Visual Acuity assessed assessed for test lens and comfilcon A control lens using logMAR VA	Up to 1 week
Secondary	Biomicroscopy - Corneal Staining Extent - Study Test Lens	Investigator assessment using 5 categories: 0=No staining, 1=1-15% of area, 2=16-30% of area, 3=31-45% of area, 4= >45% of area, using integer scale	Baseline, 1 week follow-up visit
Secondary	Biomicroscopy - Corneal Staining Extent - comfilcon A	Investigator assessment using 5 categories: 0=No staining, 1=1-15% of area, 2=16-30% of area, 3=31-45% of area, 4= >45% of area, using integer scale	Baseline, 1 week follow-up visit
Secondary	Biomicroscopy - Corneal Staining Depth - Study Test Lens	Investigator assessment using 5 categories: 0=No staining, 1=Superficial epithelium, 2=Deep epithelium, delayed stromal glow, 3=Immediate localized stromal glow, 4=Immediate diffuse stromal glow, or full thickness abrasion in 0.50 steps.	Baseline, 1 week follow-up visit
Secondary	Biomicroscopy - Conjunctival Staining - Study Test Lens	Investigator assessment using 5 categories: 0=None, 1=Minimal diffuse punctate, 2=Coalescent punctate, 3=Confluent, 4=Deep confluent in 0.50 steps	Baseline, 1 week follow-up visit
Secondary	Biomicroscopy - Conjunctival Staining - comfilcon A	Investigator assessment using 5 categories: 0=None, 1=Minimal diffuse punctate, 2=Coalescent punctate, 3=Confluent, 4=Deep confluent in 0.50 steps	Baseline, 1 week follow-up visit
Secondary	Centration	Investigator assessment using Grading Categories: Optimally Centered, Slightly Decentered (<0.5mm) Nasal, Temporal, Superior, Inferior (NTSI), Extremely Decentered (>0.5mm) NTSI	Baseline
Secondary	Centration	Investigator assessment using Grading Categories: Optimally Centered, Slightly Decentered (<0.5mm) Nasal, Temporal, Superior, Inferior (NTSI), Extremely Decentered (>0.5mm) NTSI	1 week follow-up visit
Secondary	Post Blink Movement	Investigator assessment of amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps) for test lens and comfilcon A lens.	Baseline,1 week follow-up visit
Secondary	Push - Up Test	Investigator assessment of push-up test for test lens and comfilcon A lens using continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement	Baseline,1 week follow-up visit
Secondary	Mobility Rating	Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps	Baseline,1 week follow-up visit
Secondary	Overall Lens Fit Acceptance	Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps	Baseline,1 week follow-up visit
Secondary	Lens Surface Quality	Investigator assessment using 5 Categories in 0.25 steps: 0=Very Poor; 1=Poor; 2=Acceptable; 3=Good; 4=Excellent	Baseline,1 week follow-up visit
Secondary	Lens Surface Quality - comfilcon A	Investigator assessment using 5 Categories in 0.25 steps: 0= Very poor; 1=Poor; 2=Acceptable; 3=Good; 4=Excellent	Baseline,1 week follow-up visit
Secondary	Ghosting - Distance Vision	Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable	Baseline, 1 week follow-up visit
Secondary	Ghosting - Near Vision	Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable	Baseline, 1 week follow-up visit
Secondary	Overall Comfort	Patient subjective scoring using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever.	Baseline,1 week follow-up visit
Secondary	Overall Dryness	Patient subjective scoring using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time.	Baseline,1 week follow-up visit
Secondary	Lens Preference - Distance Vision	Subjective rating for lens preference for distance vision assessed at 2 week follow-up visit. (Study test lens or comfilcon A)	2 week follow-up visit