A 6-Hour Clinical Evaluation of New Daily-Wear Soft Contact Lenses

Myopia Clinical Trial

Official title:

A 6-Hour Clinical Evaluation of New Daily-Wear Soft Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03235089
• Other study ID #: CV-17-46
• Status: Completed
• Phase: N/A
• Start date: July 25, 2017
• Est. completion date: August 3, 2017

Study information

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

Clinical Trial Summary

The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 6 hours compared to nelfilcon A (control).

Description:

The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 6 hours compared to nelfilcon A (control). The primary outcomes of interest are lens fit and lens fit preference.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 3, 2017
• Est. primary completion date: August 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Is at least 18 years of age and has full legal capacity to volunteer

• Has read, fully understood and signed the information consent letter

• Currently wears or has previously worn soft contact lenses

• Has spectacle cylinder =1.00D in both eyes.

• Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.

• Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye.

• Has clear corneas and no active ocular disease

• Is willing and able to follow product usage instructions and maintain the visit schedule.

Exclusion Criteria:

• Has never worn contact lenses before

• Has a systemic condition that in the opinion of the investigator may affect a study outcome variable

• Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable

• Has any known active ocular disease and/or infection

• Has a monovision correction

• Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses

• Is aphakic

• Has undergone corneal refractive surgery

• Is pregnant or lactating, determined by self-report

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Test Lens
Daily disposable contact lens
• Control Lens
Focus Dailies All Day Comfort contact lens (nelfilcon A)

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	Horizontal Lens Centration Assessed in Primary Gaze	Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)	Baseline
Primary	Horizontal Lens Centration Assessed in Primary Gaze	Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)	6-hour
Primary	Vertical Lens Centration Assessed in Primary Gaze	Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)	Baseline
Primary	Vertical Lens Centration Assessed in Primary Gaze	Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)	6-hours
Primary	Lens Tightness Assessed by Push-up Test	Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)	Baseline
Primary	Lens Tightness Assessed by Push-up Test	Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)	6-hours
Primary	Primary Gaze Lag Assessed Observing Lens Movement in Graticule	Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)	Baseline
Primary	Primary Gaze Lag Assessed Observing Lens Movement in Graticule	Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)	6 hours
Primary	Horizontal Lens Lag Assessed Observing Lens Movement in Graticule	Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)	Baseline
Primary	Horizontal Lens Lag Assessed Observing Lens Movement in Graticule	Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)	6 hours
Primary	Overall Lens Fit Acceptance	Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)	Baseline
Primary	Overall Lens Fit Acceptance	Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)	6 hours
Primary	Up Gaze Lag Assessed Observing Lens Movement in Graticule	Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze).	Baseline
Primary	Up Gaze Lag Assessed Observing Lens Movement in Graticule	Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze).	6 hours
Primary	Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink	Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink	Baseline
Primary	Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink	Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink	6 hours