A Comparison of Two Daily Disposable Contact Lenses.

NCT00721500 | Completed Results

• 2 other identifiers: CR-0812PROD-502
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Refractive Error; Myopia

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

narafilcon A / etafilcon A - etafilcon A - narafilcon A

EXPERIMENTAL

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; Device: narafilcon A

narafilcon A / etafilcon A - narafilcon A - etafilcon A

EXPERIMENTAL

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; Device: narafilcon A

narafilcon A - etafilcon A - narafilcon A / etafilcon A

EXPERIMENTAL

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; Device: narafilcon A

etafilcon A - narafilcon A - narafilcon A / etafilcon A

EXPERIMENTAL

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; Device: narafilcon A

Interventions

etafilcon A DEVICE

contact lens

Also known as: 1-Day Acuvue Moist

etafilcon A - narafilcon A - narafilcon A / etafilcon A; narafilcon A - etafilcon A - narafilcon A / etafilcon A; narafilcon A / etafilcon A - etafilcon A - narafilcon A; narafilcon A / etafilcon A - narafilcon A - etafilcon A

narafilcon A DEVICE

contact lens

Also known as: TruEye

etafilcon A - narafilcon A - narafilcon A / etafilcon A; narafilcon A - etafilcon A - narafilcon A / etafilcon A; narafilcon A / etafilcon A - etafilcon A - narafilcon A; narafilcon A / etafilcon A - narafilcon A - etafilcon A

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead
• Visioncare Research Ltd.: collaborator

Study Sites (1)

Visioncare Research Ltd

Farnham, Surrey, GU9 7EN, United Kingdom

Location

MeSH Terms

Conditions

Refractive Errors; Myopia

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Kurt Moody OD FAOO / Director
• Organization: Vistakon

904-443-3088

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2008
• First Posted: July 24, 2008
• Study Start: June 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: May 21, 2015
• Results First Posted: March 2, 2011

Record last verified: 2015-05

Locations

GB (1)