One Week Assessment of a Lens With a Novel Optical Profile

Myopia Clinical Trial

Official title:

One Week Assessment of a Lens With a Novel Optical Profile

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02642354
• Other study ID #: CV-15-75-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: 20
• 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 >= 1 line 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	Clinical Research Center, University of California, Berkeley	Berkeley	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	High Illumination High Contrast (HIHC) Distance Visual Acuity	High Illumination High Contrast (HIHC) Visual Acuity for distance was measured by logMAR (Logarithm of the Minimum Angle of Resolution).	Up to 1 week
Primary	High Illumination High Contrast (HIHC) Near Visual Acuity	High Illumination High Contrast (HIHC) Near Visual Acuity for test and control lenses was measured by logMAR.	Up to 1 week
Primary	Low Illumination High Contrast (LIHC) Distance - Visual Acuity	Low Illumination High Contrast (LIHC) distance - visual acuity for distance vision was measured by logMAR.	Up to 1 week
Primary	Low Illumination High Contrast (LIHC) Near - Visual Acuity	Low Illumination High Contrast (LIHC) near visual acuity near was measured by LogMAR	Up to 1 week
Primary	Quality of Vision - Distance	Patient 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	Patient 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 - Intermediate	Patient 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 - digital device use	Patient 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 - overall	Patient 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
Secondary	Corneal Staining - Extent	Investigator assessment of 4 locations (central, nasal, temporal, superior) for both comfilcon A asphere lens (test) and comfilcon A sphere lens (control) assessed at baseline and 1 week 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 and 1 week
Secondary	Conjunctival Staining	Investigator assessment of 4 locations (nasal, temporal, superior, inferior) for both comfilcon A asphere lens (test) and comfilcon A sphere lens (control) assessed at baseline and 1 week using 5 categories: 0=None, 1=Minimal diffuse punctate, 2=Coalescent punctate, 3=Confluent, 4=Deep confluent in 0.50 steps	Baseline and 1 week
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
Secondary	Post Blink Movement	Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)	Baseline and 1 week
Secondary	Push - Up Test	Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement	Baseline and 1 week
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 and 1 week
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 and 1 week
Secondary	Ghosting - Distance Vision	Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable	Baseline and 1 week
Secondary	Ghosting - near vision	Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable	Baseline and 1 week
Secondary	Overall Comfort	Patient subjective scoring using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever.	Baseline and 1 week
Secondary	Overall Dryness	Patient subjective scoring using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time.	Baseline and 1 week