Dispensing Study for a New Study Lens

Myopia Clinical Trial

Official title:

Dispensing Study for The Phenacite Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02642991
• Other study ID #: CV-15-41
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: March 2016

Study information

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

Clinical Trial Summary

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

Description:

This study was 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.

Other known NCT identifiers

• NCT02642341
• NCT02642354

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• 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 (Diopoter) 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

• Has previously participated in study of the Phenacite lenses

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Phenacite
contact lens
• comfilcon A
contact lens

Locations

Country	Name	City	State
Canada	Center for Contact Lens Research, University of Waterloo	Waterloo	Ontario
United States	University of California	Berkeley	California
United States	CORL, Indiana University	Bloomington	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance Visual Acuity (VA) - High Illumination	Distance visual acuity High Illumination was assessed using logMAR	Baseline (after 10 minutes of lens dispense)
Primary	Distance Visual Acuity (VA) - High Illumination	Distance visual acuity High Illumination was assessed using logMAR	1 week
Primary	Near Visual Acuity (VA) - High Illumination	Near Visual Acuity (VA) - High Illumination assessed using logMAR	Baseline (after 10 minutes of lens dispense)
Primary	Near Visual Acuity (VA) - High Illumination	Near Visual Acuity (VA) - High Illumination assessed using logMAR	1 week
Primary	Distance Visual Acuity (VA) - Low Illumination	Distance Visual Acuity (VA) - Low Illumination assessed using logMAR	Baseline (after 10 minutes of lens dispense)
Primary	Distance Visual Acuity (VA) - Low Illumination	Distance Visual Acuity (VA) - Low Illumination assessed using logMAR	1 week
Primary	Near Visual Acuity (VA) - Low Illumination	Near Visual Acuity (VA) - Low illumination assessed using logMAR	Baseline (after 10 minutes of lens dispense)
Primary	Near Visual Acuity (VA) - Low Illumination	Near Visual Acuity (VA) - Low illumination assessed using logMAR	1 week
Primary	Quality of Distance Vision	Subjective scoring of Quality of Distance Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)	Baseline (after 10 minutes of lens dispense)
Primary	Quality of Distance Vision	Subjective scoring of Quality of Distance Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)	1 week
Primary	Quality of Near Vision	Patient subjective scoring for quality of near vision using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time	Baseline (After 10 minutes of lens dispense)
Primary	Quality of Near Vision	Patient subjective scoring for quality of near vision using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time	1 week
Primary	Quality of Vision With Digital Device Use	Subjective scoring of Quality of Vision with digital device use assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)	Baseline (After 10 minutes of lens dispense)
Primary	Quality of Vision With Digital Device Use	Subjective scoring of Quality of Vision with digital device use assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)	1 week
Primary	Quality of Intermediate Vision	Subjective scoring of Quality of Intermediate Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)	Baseline (After 10 minutes of lens dispense)
Primary	Quality of Intermediate Vision	Subjective scoring of Quality of Intermediate Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)	1 week
Primary	Overall Vision Quality	Subjective scoring of overall vision quality assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)	Baseline (After 10 minutes of lens dispense)
Primary	Overall Vision Quality	Subjective scoring of overall vision quality assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)	1 week
Secondary	Biomicroscopy Findings - Bulbar Hyperemia	Bulbar hyperemia assessment using 5 categories: (0=None, 1= Slight injection to conjunctival vessels, 2= Mild injection, 3= Moderate injection, 4= Severe injection) in (0.25 steps)	1 week
Secondary	Biomicroscopy Findings- Limbal Hyperemia	Investigator assessment using 5 categories: (0=None, 1= Slight injection to conjunctival vessels, 2= Mild injection, 3= Moderate injection, 4= Severe injection) in (0.25 steps)	1 week
Secondary	Biomicroscopy Findings - Corneal Staining Extent	Investigator Assessment on Biomicroscopy Findings - Corneal Staining Extent on a scale of 0-4 : 0=No staining, 1=1-15% of area, 2=16-30% of area, 3=31-45% of area, 4= >45% of area	1 week
Secondary	Ghosting - Distance Vision	Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable	1 week
Secondary	Ghosting - Near Vision	Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable	1 week
Secondary	Overall Comfort	Patient subjective scoring using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever.	Baseline (After 10 minutes of lens dispense)
Secondary	Overall Comfort	Patient subjective scoring for overall comfort using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever.	1 week
Secondary	Overall Dryness	Patient subjective scoring for overall dryness using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time.	Baseline (after 10 minutes of lens dispense)
Secondary	Overall Dryness	Patient subjective scoring for overall dryness using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time.	1 week
Secondary	Lens Preference - Overall Vision Preference	Subjective rating of lens preference for overall vision preference (Phenacite, comfilcon A, No preference)	1 week
Secondary	Subjective Ratings of Change in Frequency of Tiredness	Subjective rating of change in eye fatigue frequency of tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)	1 week
Secondary	Subjective Ratings of Change in Severity of Tiredness	Subjective rating of change in eye fatigue severity of tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)	1 week
Secondary	Subjective Ratings of Change in Bothersome Rating for Tiredness	Subjective rating of change in eye fatigue bothersome rating for tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)	1 week
Secondary	Subjective Ratings of Change in Frequency of Dryness	Subjective rating of change in eye fatigue frequency of dryness assessed using Eye fatigue Experience Questionnaire (EFEG)	1 week
Secondary	Subjective Ratings of Change in Severity of Dryness	Subjective rating of change in eye fatigue severity of dryness assessed using Eye fatigue Experience Questionnaire (EFEG)	1 week
Secondary	Subjective Ratings of Change in Bothersome Rating of Dryness	Subjective rating of change in eye fatigue bothersome rating for dryness assessed using Eye fatigue Experience Questionnaire (EFEG)	1 week
Secondary	Subjective Questionnaire Response - Eye Strain	Subjective questionnaire response for " My eyes don't feel strained while wearing these lenses" - Agree, Disagree	1 week
Secondary	Subjective Questionnaire Response - Eye Feel Good	Subjective questionnaire response for " These lenses make my eyes feel good" - Agree, Disagree	1 week
Secondary	Subjective Questionnaire Response - Eye Feel Relaxed	Subjective questionnaire response for " These lenses make my eyes feel relaxed" - Agree, Disagree	1 week
Secondary	Subjective Questionnaire Response - Vision	Subjective questionnaire response for " These lenses help my vision" - Agree, Disagree	1 week
Secondary	Subjective Questionnaire Response - Eye Tired	Subjective questionnaire response for " These lenses make my eyes feel less tired" - Agree, Disagree	1 week