A Comparison of Two Daily Disposable Contact Lenses.

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00721500
• Other study ID #: CR-0812
• Secondary ID: PROD-502
• Status: Completed
• Phase: N/A
• First received: July 22, 2008
• Last updated: May 5, 2015
• Start date: June 2008
• Est. completion date: July 2008

Study information

• Verified date: May 2015
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia
• Refractive Error
• Refractive Errors

Intervention

Device:
• etafilcon A
contact lens
• narafilcon A
contact lens

Locations

Country	Name	City	State
United Kingdom	Visioncare Research Ltd	Farnham	Surrey

Sponsors (2)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.	Visioncare Research Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No