Comparison of Two Daily Disposable Soft Contact Lenses

Astigmatism Bilateral Clinical Trial

Official title:

A Clinical Comparison of Two Daily Disposable Soft Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03779503
• Other study ID #: EX-MKTG-99 (C18-649)
• Status: Completed
• Phase: N/A
• Start date: February 8, 2019
• Est. completion date: September 18, 2019

Study information

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

Clinical Trial Summary

The aim of this study was to investigate the short-term clinical performance and subjective acceptance of the two study lenses.

Description:

This study was a randomised, double-masked, crossover, bilateral dispensing study, controlled by cross-comparison. Fifty-five subjects will wear each lens brand for approximately one week in random order. Lenses were worn on a daily wear, daily disposable basis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 18, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. They are between 18 and 40 years of age (inclusive).

2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.

3. They are willing and able to follow the protocol.

4. They are an existing silicone hydrogel reusable spherical contact lens wearer in both eyes.

5. They have a contact lens spherical prescription between -0.25D and -6.00D (inclusive) based on ocular refraction.

6. They own a wearable pair of spectacles and wear them on the day of the initial visit.

7. At dispensing, they can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.

8. They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).

9. They agree not to participate in other clinical research for the duration of the study.

Exclusion Criteria:

1. They have an ocular disorder, which would normally contra-indicate contact lens wear.

2. They have a systemic disorder, which would normally contra-indicate contact lens wear.

3. They are using any topical medication such as eye drops or ointment, or use any rewetting/lubricating drops whilst on this study.

4. They are aphakic.

5. They have had corneal refractive surgery.

6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.

7. They are pregnant or breastfeeding.

8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear

9. They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.

10. They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.

Related Conditions & MeSH terms

• Astigmatism
• Astigmatism Bilateral

Intervention

Device:
• midafilcon A
midafilcon A 1 day daily disposable contact lens
• somofilcon A
somofilcon A 1 day daily disposable contact lens

Locations

Country	Name	City	State
United States	CooperVision Inc.	Pleasanton	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	Lens Fit - Horizontal Centration	Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)	Baseline
Primary	Lens Fit - Horizontal Centration	Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)	One Week
Primary	Lens Fit - Vertical Centration	Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)	Baseline
Primary	Lens Fit - Vertical Centration	Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)	One Week
Primary	Lens Fit - Corneal Coverage	Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)	Baseline
Primary	Lens Fit - Corneal Coverage	Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)	One Week
Primary	Lens Fit - Lens Movement	Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)	Baseline
Primary	Lens Fit - Lens Movement	Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)	One Week
Secondary	Subjective Score for Vision	Subjects will score on visual analogue scale for vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent)	Baseline
Secondary	Subjective Score for Vision	Subjects will score on visual analogue scale for Vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent)	One week