A Comparison of Two Daily Disposable Contact Lenses.

An Evaluation of the Lens Fit of Narafilcon A Soft Contact Lenses

This study seeks to evaluate the clinical fitting performance of a new daily disposable contact lens to an existing daily disposable contact lens.

Study Overview

• Status: Completed
• Conditions: Refractive Error; Myopia
• Intervention / Treatment: Device: etafilcon A; Device: narafilcon A

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey
    • Farnham, Surrey, United Kingdom, GU9 7EN
      • Visioncare Research Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• They are of legal age (18 years) and capacity to volunteer.
• 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 would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
• They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.
• They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).
• They have successfully worn contact lenses within six months of starting the study.

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.
• They are aphakic.
• They have had corneal refractive surgery.
• They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
• They are pregnant or lactating.
• They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
• They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).
• They have diabetes.
• They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: narafilcon A / etafilcon A - etafilcon A - narafilcon A; First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A contact lenses worn in both eyes.	Device: etafilcon A; contact lens; Other Names: 1-Day Acuvue Moist; Device: narafilcon A; contact lens; Other Names: TruEye
Experimental: narafilcon A / etafilcon A - narafilcon A - etafilcon A; First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, narafilcon A contact lenses worn in both eyes. Third, etafilcon A contact lenses worn in both eyes.	Device: etafilcon A; contact lens; Other Names: 1-Day Acuvue Moist; Device: narafilcon A; contact lens; Other Names: TruEye
Experimental: narafilcon A - etafilcon A - narafilcon A / etafilcon A; First, narafilcon A contact lenses worn in both eyes. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.	Device: etafilcon A; contact lens; Other Names: 1-Day Acuvue Moist; Device: narafilcon A; contact lens; Other Names: TruEye
Experimental: etafilcon A - narafilcon A - narafilcon A / etafilcon A; First, etafilcon A contact lenses worn in both eyes. Second, narafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.	Device: etafilcon A; contact lens; Other Names: 1-Day Acuvue Moist; Device: narafilcon A; contact lens; Other Names: TruEye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Eyes Successfully Fit	Overall lens fit acceptance was assessed by the Investigator based on lens fit alone in a 6-level scale; 0=should not be worn, 1=should not be dispensed although no immediate danger, 2=borderline but unacceptable, 3=minimal acceptable, early review, 4=not perfect but OK to dispense and 5=perfect. Lens fitting responses >2 were considered 'successful fit' while the rest of responses were considered 'unsuccessful fit'.	Within 20 minutes of lens insertion
Lens Fit Decentration	Lens centration was assessed in primary gaze, diffuse white light, low-medium magnification, with graticule. Lens fit decentration with respect to visible cornea was measured to nearest 0.1mm.	Within 20 minutes of lens insertion
Lens Tightness on Cornea With Manual Digit Push Up	Lens tightness on push-up assessed by digital push-up test (gentle push of the lens upward using the lower lid) with eye in primary gaze position and observing ease of push-up and speed of return to original position. Tightness is measured on a 0%-100% continuous scale where 0%=falls from cornea without lid support, 50%=optimum and 100%=no movement.	Within 20 minutes of lens insertion

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.
• Collaborators: Visioncare Research Ltd.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: July 22, 2008
• First Submitted That Met QC Criteria: July 22, 2008
• First Posted (Estimate): July 24, 2008

Study Record Updates

• Last Update Posted (Estimate): May 21, 2015
• Last Update Submitted That Met QC Criteria: May 5, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CR-0812; PROD-502