Clinical Comparison of Silicone Hydrogel and HEMA-based Daily Disposable Contact Lenses

Ciba Vision

Status: Completed

Conditions: Myopia

Treatments: Device: Etafilcon A contact lens; Device: Delefilcon A contact lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT01362907

P-347-C-013

Details and patient eligibility

About

The purpose of this trial was to compare the performance of an investigational daily disposable contact lens to a commercially available daily disposable contact lens.

Enrollment: 40 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Normal eyes with no use of ocular medications.
• Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
• Willing and able to wear spherical contact lenses for protocol-specified timeframe within the available range of powers (-1.00 D to -6.00D in 0.25D steps).
• Visual acuity with study lenses 20/25 or better.
• Cylinder less than or equal to 0.75 D.
• Currently wearing daily disposable lenses.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Anterior segment infection, inflammation, or abnormality.
• Any active anterior segment ocular disease that would contraindicate contact lens wear.
• Any use of systemic medications for which contact lens wear could be contraindicated as determined by the investigator.
• History of refractive surgery or irregular cornea.
• Eye injury within twelve weeks immediately prior to enrollment for this trial.
• Currently enrolled in any clinical trial.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Delefilcon A / etafilcon A

Other group

Description:

Delefilcon A contact lenses worn first, with etafilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.

Treatment:

Device: Delefilcon A contact lens

Device: Etafilcon A contact lens

Etafilcon A / delefilcon A

Other group

Description:

Etafilcon A contact lenses worn first, with delefilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.

Treatment:

Device: Delefilcon A contact lens

Device: Etafilcon A contact lens