Dispensing Study for the Phenacite Project

Ametropia Clinical Trial

Official title:

Dispensing Study for the Phenacite Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02436005
• Other study ID #: CV-15-16
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: July 2015

Study information

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

Clinical Trial Summary

Dispensing Study for the Phenacite Project.

The investigational test lens was not the final optical design and the study was not used for design validation.

Description:

Evaluate the objective and patient-reported visual acceptability of the Phenacite contact lens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• 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 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:

• 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 Visual Acuity

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

• Has participated in study CV-14-32.

Related Conditions & MeSH terms

• Ametropia
• Refractive Errors

Intervention

Device:
• Phenacite
Subjects will be randomized to wear the Phenacite contact lenses binocularly.
• comfilcon A
Subjects will be randomized to wear the comfilcon A contact lenses binocularly.

Locations

Country	Name	City	State
United States	Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University	Bloomington	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	Subjective Ratings of Lens Comfort	Subjective ratings of lens comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)	Baseline (after 15 minutes of lens dispense)
Primary	Subjective Ratings of Lens Comfort	Subjective ratings of lens comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)	2 Weeks
Primary	Over Refraction for Optimized Distance Acuity	Over Refraction for optimized distance acuity measured using logMAR	2 weeks
Primary	Binocular Distance Visual Acuity - High Illumination High Contrast	Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR	Baseline (after 5 minutes of lens dispense)
Primary	Binocular Distance Visual Acuity - High Illumination High Contrast	Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR	2 weeks
Primary	Binocular Distance Visual Acuity - Low Illumination High Contrast	Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR	Baseline (after 5 minutes of lens dispense)
Primary	Binocular Distance Visual Acuity - Low Illumination High Contrast	Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR	2 weeks
Primary	Binocular Near Visual Acuity - High Illumination High Contrast	Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR	Baseline (after 5 minutes of lens dispense)
Primary	Binocular Near Visual Acuity - High Illumination High Contrast	Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR	2 weeks
Primary	Binocular Near Visual Acuity - Low Illumination High Contrast	Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR	Baseline (after 5 minutes of lens dispense)
Primary	Binocular Near Visual Acuity - Low Illumination High Contrast	Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR	2 weeks
Secondary	Lens Fit - Post Blink Movement	Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)	Baseline (after 15 minutes of lens dispense)
Secondary	Lens Fit - Post Blink Movement	Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)	2 weeks
Secondary	Push - Up Test for Lens Tightness	Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement	Baseline (after 15 minutes of lens dispense)
Secondary	Push - Up Test for Lens Tightness	Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement	2 weeks
Secondary	Lens 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 (after 15 minutes of lens dispense)
Secondary	Lens 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	2 weeks
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 (after 15 minutes of lens dispense)
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	2 weeks
Secondary	Subjective Ratings for Vision Quality - Distance Vision	Patient subjective scoring using 0-100 continuous scale for Distance Quality of Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time	Baseline (after 15 minutes of lens dispense)
Secondary	Subjective Ratings for Vision Quality - Distance Vision	Patient subjective scoring using 0-100 continuous scale for Distance Quality of Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time	2 weeks
Secondary	Subjective Ratings for Vision Quality - Near Vision	Patient subjective scoring using 0-100 continuous scale for Near Quality of Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time	Baseline (after 15 minutes of lens dispense)
Secondary	Subjective Ratings for Vision Quality - Near Vision	Patient subjective scoring using 0-100 continuous scale for Near Quality of Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time	2 weeks
Secondary	Subjective Ratings for Vision Quality - Computer Vision	Patient subjective scoring using 0-100 continuous scale for Computer Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time	Baseline (after 15 minutes of lens dispense)
Secondary	Subjective Ratings for Vision Quality - Computer Vision	Patient subjective scoring using 0-100 continuous scale for Computer Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time	2 weeks
Secondary	Subjective Ratings for Vision Quality - Overall Vision	Patient subjective scoring using 0-100 continuous scale for Overall Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time	Baseline (after 15 minutes of lens dispense)
Secondary	Subjective Ratings for Vision Quality - Overall Vision	Patient subjective scoring using 0-100 continuous scale for Overall Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time	2 weeks
Secondary	Corneal Staining Extent	Corneal staining extent was assessed 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	2 weeks
Secondary	Conjunctival Staining	Conjunctival staining was assessed on a scale of 0-4, 0.50 steps (0-None, 1 - Minimal diffuse punctuate, 2- Coalescent Punctuate, 3- confluent, 4- Deep confluent	2 weeks