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Clinical Performance of Two Daily Disposable Contact Lenses - Study 1

Clinical Performance of Two Daily Disposable Contact Lenses - Study 1

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03969290
Enrollment
69
Registered
2019-05-31
Start date
2019-06-05
Completion date
2019-08-05
Last updated
2019-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractive Errors

Keywords

Contact lens, Vision correction, Visual acuity, Daily disposable contact lens

Brief summary

The purpose of this study is to evaluate end of day (EOD) visual acuity (VA) at distance when wearing Precision1™ contact lenses compared to Acuvue® Moist contact lenses.

Detailed description

The expected duration of subject participation in the study is 1-8 days, with 3 scheduled visits (Screening, Dispense, Exit).

Interventions

Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)

Daily disposable contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)

Sponsors

Alcon Research
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Intervention model description

Contralateral

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Able to understand and sign an approved Informed Consent form * Successful wear of spherical soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day * Best corrected VA of logMAR 0.10 or better in each eye * Willing to discontinue artificial tears and rewetting drops during the study * Able to wear contact lenses within the protocol-specified sphere power range * Other protocol-specified inclusion criteria may apply.

Exclusion criteria

* Any anterior segment infection, inflammation, or abnormality or disease that contraindicates contact lens wear, as determined by the Investigator * Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator * History of ocular or intraocular surgery, including refractive surgery, and/or irregular cornea * Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment * Previous 3 years or current wearers of Acuvue Moist or DAILIES TOTAL1® contact lenses * Other protocol-specified

Design outcomes

Primary

MeasureTime frameDescription
End of day (EOD) visual acuity at distanceDay 1, after 8 hours of wearVisual acuity (VA) will be measured in logarithm of the minimum angle of resolution (logMAR). A lower logMAR value indicates better visual acuity.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026