Daily Disposable Dispensing Clinical Trial of Test Lens Against Stenfilcon A Lens

Myopia Clinical Trial

Official title:

Daily Disposable Dispensing Clinical Trial of Test Lens Against Stenfilcon A Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03024970
• Other study ID #: CV-16-60
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: June 26, 2017

Study information

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

Clinical Trial Summary

The purpose of this study is to investigate the overall clinical performance of the test daily disposable stenfilcon A lens with solution additive (test) compared to the stenfilcon A lens (control).

Description:

This will be, prospective, multicenter, double-masked, randomized, bilateral, 1 month cross-over, dispensing study comparing the test lens against the stenfilcon A control lens with a study duration of approximately two months.

Each subject will be randomized to wear either the test or control as a matched pair first and subjects will be randomized based on the order in which the subject is enrolled and qualified into the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 26, 2017
• Est. primary completion date: April 25, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• Has had a self-reported oculo-visual examination in the last two years.

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

• Has read and understood the information consent letter.

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

• Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.

• Must achieve 20/30 or better (in each eye) with study lenses

• Requires spectacle lens powers between -0.75 and -6.50 diopters sphere (0.25D steps).

• Has no more than 0.75 diopters of refractive astigmatism.

• Currently wears soft contact lenses.

• Have clear corneas and no active ocular disease.

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

Exclusion Criteria:

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

• Has never worn contact lenses before.

• Has any systemic disease affecting ocular health.

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

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

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

• Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.

• Is aphakic.

• Has undergone corneal refractive surgery.

• Is pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).

• Have taken part in any other contact lens or care solution clinical trial or research, within one week prior to starting this study.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• stenfilcon A lens with solution additive (test)
silicone hydrogel lens
• stenfilcon A lens (control)
contact lens

Locations

Country	Name	City	State
United States	Clinical Optical Research Lab (CORL)	Bloomington	Indiana
United States	The Ocular Surface Institute (TOSI)	Houston	Texas

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 on Comfort	Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable	Baseline
Primary	Subjective Ratings on Comfort	Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable	1 Week
Primary	Subjective Ratings on Comfort	Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable	1 Month
Primary	Vision Satisfaction	Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree	Baseline
Primary	Vision Satisfaction	Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree	1 week
Primary	Vision Satisfaction	Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree	1 Month
Primary	Visual Acuity On High Illumination High Contrast	Visual acuity is assessed on high illumination high contrast logMAR charts for test and control lenses. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.	Baseline
Primary	Visual Acuity On High Illumination High Contrast	Visual acuity is assessed on high illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.	1 Week
Primary	Visual Acuity On High Illumination High Contrast	Visual acuity is assessed on high illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.	1 Month
Primary	Visual Acuity On Low Illumination High Contrast	Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.	Baseline
Primary	Visual Acuity On Low Illumination High Contrast	Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.	1 Week
Primary	Visual Acuity On Low Illumination High Contrast	Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.	1 Month
Primary	Overall Corneal Staining	Overall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe.	One Week
Primary	Overall Corneal Staining	Overall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe.	One Month
Primary	Conjunctival Staining	Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent	1 Week
Primary	Conjunctival Staining	Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent	1 Month
Primary	Bulbar Hyperemia	Bulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)	1 Week
Primary	Bulbar Hyperemia	Bulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)	1 Month
Primary	Limbal Hyperemia	Limbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)	1 Week
Primary	Limbal Hyperemia	Limbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)	1 Month
Primary	Palpebral Hyperemia	Palpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)	1 Week
Primary	Palpebral Hyperemia	Palpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)	1 Month
Secondary	Lens Fit Acceptance	Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.	Baseline
Secondary	Lens Fit Acceptance	Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.	1 week
Secondary	Lens Fit Acceptance	Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.	1 Month
Secondary	Handling Satisfaction	Handling satisfaction is assessed for test and control lens. 5 point Likert scale: 1- Strongly disagree, 2-disagree, 3-neutral, 4-agree, 5- strongly agree	1 week
Secondary	Handling Satisfaction	Handling satisfaction is assessed for test and control lens. 5 point Likert scale: 1- Strongly disagree, 2-disagree, 3-neutral, 4-agree, 5- strongly agree	1 Month
Secondary	Lens Surface - Wettability	Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent	Baseline
Secondary	Lens Surface - Wettability	Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent	1 Week
Secondary	Lens Surface - Wettability	Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent	1 Month
Secondary	Lens Surface - Deposits	Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.	Baseline
Secondary	Lens Surface - Deposits	Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.	1 week
Secondary	Lens Surface - Deposits	Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.	1 Month
Secondary	Subjective Ratings on Dryness	Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry	Baseline
Secondary	Subjective Ratings on Dryness	Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry	1 week
Secondary	Subjective Ratings on Dryness	Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry	1 Month