A Comparison of Two Daily Disposable Contact Lenses

• ClinicalTrials.gov Identifier: NCT00600080
• Recruitment Status: Completed
• First Posted: January 24, 2008
• Results First Posted: August 23, 2012
• Last Update Posted: May 21, 2015
• Sponsor: Johnson & Johnson Vision Care, Inc.
• Collaborator: University of Manchester
• Information provided by (Responsible Party): Johnson & Johnson Vision Care, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Myopia	Device: etafilcon A; Device: nelfilcon A	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: The Comparative Clinical Performance of the Etafilcon A Lens and the DAILIES AquaComfort Plus Lens
• Study Start Date: December 2007
• Actual Primary Completion Date: March 2008
• Actual Study Completion Date: March 2008

Arms and Interventions

Arm	Intervention/treatment
etafilcon A first nelfilcon A second; etafilcon A worn daily during week 1, nelfilcon A worn daily for week 2	Device: etafilcon A; contact lens worn daily for one week (first or second week depending on arm); Other Name: 1-DAY ACUVUE MOIST; Device: nelfilcon A; Contact lens worn daily for one week (first or second week depending on arm); Other Name: DAILIES AquaComfort Plus
nelfilcon A first, etafilcon A second; nelfilcon A worn daily during week 1, etafilcon A worn daily for week 2	Device: etafilcon A; contact lens worn daily for one week (first or second week depending on arm); Other Name: 1-DAY ACUVUE MOIST; Device: nelfilcon A; Contact lens worn daily for one week (first or second week depending on arm); Other Name: DAILIES AquaComfort Plus

Outcome Measures

Primary Outcome Measures :

1. Visual Acuity [ Time Frame: 2-week ]
   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. Subjective Lens Comfort [ Time Frame: 2-week ]
   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.

Secondary Outcome Measures :

1. Subject-reported Overall Product Performance [ Time Frame: 2-week ]
   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. Optimum Lens Fit [ Time Frame: Baseline, 1-week, 2-week ]
   Number of subjects that measured as an optimum fit. Lens fit will be assessed using the following evaluations: horizontal and vertical centration, corneal coverage and movement. Normally, for an acceptable fit, centration and movement will fall within currently accepted clinical criteria [between -1 and +1 on a -2 to +2 grading scale.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. They are of legal age (18 years) and capacity to volunteer.
2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
3. They are willing and able to follow the protocol.
4. They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
5. They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.
6. They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).
7. They have successfully worn contact lenses within six months of starting the study. -

Exclusion Criteria:

1. They have an ocular disorder which would normally contra-indicate contact lens wear.
2. They have a systemic disorder which would normally contra-indicate contact lens wear.
3. They are using any topical medication such as eye drops or ointment.
4. They are aphakic.
5. They have had corneal refractive surgery.
6. They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
7. They are pregnant or lactating.
8. 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.
9. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).
10. They have diabetes.
11. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Contacts and Locations

Locations

United Kingdom

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

Manchester, United Kingdom, M60 1QD

Sponsors and Collaborators

Johnson & Johnson Vision Care, Inc.

University of Manchester

More Information

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT00600080
• Other Study ID Numbers: CR-0729
• First Posted: January 24, 2008
• Results First Posted: August 23, 2012
• Last Update Posted: May 21, 2015
• Last Verified: May 2015

Additional relevant MeSH terms:

Myopia; Refractive Errors; Eye Diseases