A Clinical Comparison of Two Daily Disposable Contact Lenses.

Johnson & Johnson (J&J)

Status: Completed

Conditions: Myopia

Treatments: Device: nelfilcon A; Device: etafilcon A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00775021

ID08-34

CR-0814

Details and patient eligibility

About

The objective of this study is to evaluate the clinical performance of two daily disposable contact lenses.

Enrollment: 123 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 18 years to 45 years

• Current daily soft contact lens as habitual optical correction:

• Refraction:

  • Best sphere (corrected for back vertex distance) -1.00 to -6.00D
  • Cylinder 0.00 to - 0.75D

• Best spectacle corrected visual acuity of 6/9 or better in each eye

• Willingness to adhere to the instructions set in the clinical protocol

• Signature of the subject on the informed consent form

Exclusion criteria

• Systemic or ocular allergies which might interfere with contact lens wear
• Systemic disease which might interfere with contact lens wear
• Ocular disease which might interfere with contact lens wear (e.g. hypoesthesia, insufficient lacrimal secretion)
• Use of medication which might interfere with contact lens wear
• Active ocular infection
• Use of ocular medication
• Significant ocular anomaly
• Presence of two or more corneal scars in either eye
• Pregnancy or lactation
• Any medical condition that might be prejudicial to the study
• Participated in any other clinical studies in the past month
• Currently wears monovision

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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123 participants in 2 patient groups

etafilcon A/nelfilcon A

Active Comparator group

Description:

etafilcon A contact lens worn first and nelfilcon A contact lens worn second

Treatment:

Device: etafilcon A

Device: nelfilcon A

nelfilcon A/etafilcon A

Active Comparator group

Description:

nelfilcon A contact lens worn first and etafilcon A contact lens second.

Treatment:

Device: etafilcon A

Device: nelfilcon A