A Comparison of Two Daily Disposable Contact Lenses

NCT00600080 | Completed Results

• 1 other identifier: CR-0729
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to evaluate the clinical performance of a recently improved daily disposable contact lens to an established daily disposable contact lens that contains a wetting agent.

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• Visual Acuity

  Measured using high contrast and low contrast vision charts without the use of spectacles (glasses) or refraction equipment (for contact lens wearers). Values are on the logMar scale where lower values (\< 0) refer to 'better' values of sight. These scores are converted from a Snellen eye chart examination.

  2-week

• Subjective Lens Comfort

  Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= "Extremely poor" or "Cannot use lenses" and 100= "Excellent" or "Highly impressed with these lenses overall"). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used.

  2-week

Secondary Outcomes (2)

• Subject-reported Overall Product Performance

  2-week

• Optimum Lens Fit

  Baseline, 1-week, 2-week

Study Arms (2)

etafilcon A first nelfilcon A second

OTHER

etafilcon A worn daily during week 1, nelfilcon A worn daily for week 2

Device: etafilcon A; Device: nelfilcon A

nelfilcon A first, etafilcon A second

OTHER

nelfilcon A worn daily during week 1, etafilcon A worn daily for week 2

Device: etafilcon A; Device: nelfilcon A

Interventions

etafilcon A DEVICE

contact lens worn daily for one week (first or second week depending on arm)

Also known as: 1-DAY ACUVUE MOIST

etafilcon A first nelfilcon A second; nelfilcon A first, etafilcon A second

nelfilcon A DEVICE

Contact lens worn daily for one week (first or second week depending on arm)

Also known as: DAILIES AquaComfort Plus

etafilcon A first nelfilcon A second; nelfilcon A first, etafilcon A second

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• University of Manchester: collaborator

Study Sites (1)

Eurolens Research, The University of Manchester Dpt. of Optometry & Neuroscience

Manchester, M60 1QD, United Kingdom

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Kurt Moody, OD
• Organization: Johnson & Johnson Vision Care

kmoody1@its.jnj.com

+1 904 443-3088

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 24, 2008
• Study Start: December 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: May 21, 2015
• Results First Posted: August 23, 2012

Record last verified: 2015-05

Locations

GB (1)