CompletedNot Applicable

Comparison of Two Daily Disposable Soft Contact Lenses

United States55 participantsStarted 2019-02-08

Plain-language summary

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

Who can participate

Age range18 Years – 40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. They are between 18 and 40 years of age (inclusive).
✓. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
✓. They are willing and able to follow the protocol.
✓. They are an existing silicone hydrogel reusable spherical contact lens wearer in both eyes.
✓. They have a contact lens spherical prescription between -0.25D and -6.00D (inclusive) based on ocular refraction.
✓. They own a wearable pair of spectacles and wear them on the day of the initial visit.
✓. 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.
✓. They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).

Exclusion criteria

✕. They have an ocular disorder, which would normally contra-indicate contact lens wear.
✕. They have a systemic disorder, which would normally contra-indicate contact lens wear.
✕. They are using any topical medication such as eye drops or ointment, or use any rewetting/lubricating drops whilst on this study.
✕. They are aphakic.
✕. They have had corneal refractive surgery.
✕. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
✕. They are pregnant or breastfeeding.
✕. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear

What they're measuring

Lens Fit - Horizontal Centration

Timeframe: Baseline

Lens Fit - Horizontal Centration

Timeframe: One Week

Lens Fit - Vertical Centration

Timeframe: Baseline

Lens Fit - Vertical Centration

Timeframe: One Week

Lens Fit - Corneal Coverage

Timeframe: Baseline

Lens Fit - Corneal Coverage

Timeframe: One Week

Lens Fit - Lens Movement

Timeframe: Baseline

Lens Fit - Lens Movement

Timeframe: One Week

Trial details

NCT IDNCT03779503

SponsorCooperVision, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-07-30

Results submitted2020-08-25

View on ClinicalTrials.gov More Astigmatism Bilateral trials

Who can participate

Age range18 Years – 40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. They are between 18 and 40 years of age (inclusive).
✓. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
✓. They are willing and able to follow the protocol.
✓. They are an existing silicone hydrogel reusable spherical contact lens wearer in both eyes.
✓. They have a contact lens spherical prescription between -0.25D and -6.00D (inclusive) based on ocular refraction.
✓. They own a wearable pair of spectacles and wear them on the day of the initial visit.
✓. 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.
✓. They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).

Exclusion criteria

✕. They have an ocular disorder, which would normally contra-indicate contact lens wear.
✕. They have a systemic disorder, which would normally contra-indicate contact lens wear.
✕. They are using any topical medication such as eye drops or ointment, or use any rewetting/lubricating drops whilst on this study.
✕. They are aphakic.
✕. They have had corneal refractive surgery.
✕. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
✕. They are pregnant or breastfeeding.
✕. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear

What they're measuring

Lens Fit - Horizontal Centration

Timeframe: Baseline

Lens Fit - Horizontal Centration

Timeframe: One Week

Lens Fit - Vertical Centration

Timeframe: Baseline

Lens Fit - Vertical Centration

Timeframe: One Week

Lens Fit - Corneal Coverage

Timeframe: Baseline

Lens Fit - Corneal Coverage

Timeframe: One Week

Lens Fit - Lens Movement

Timeframe: Baseline

Lens Fit - Lens Movement

Timeframe: One Week