Clinical Evaluation of Two Daily Disposable Contact Lenses

Refractive Error Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01163760
• Other study ID #: CR-0706
• Secondary ID: PRO-518
• Status: Completed
• Phase: N/A
• Start date: September 2007
• Est. completion date: September 2007

Study information

• Verified date: May 2015
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study seeks to evaluate the clinical performance of two daily disposable contact lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 39 Years

Eligibility

Inclusion Criteria:

• Be between 21 and 39 years of age.

• Signed Written Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.

• Be existing (i.e. successfully worn for 1-month prior to the study) soft contact lens wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).

• Require a visual correction in both eyes (monovision allowed but no monofit).

• Have a contact lens spherical distance requirement between -1.00D and -6.00D in both eyes.

• Astigmatism of 1.00D or less in both eyes.

• Be able to wear the lens powers available for this study.

• Be correctable to a visual acuity of 20/30 or better in each eye.

• Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:

• No amblyopia.

• No evidence of lid abnormality or infection.

• No conjunctival abnormality or infection.

• No clinically significant slit lamp findings (i.e. edema, staining, scarring, vascularisation, infiltrates or abnormal opacities).

• No other active ocular disease.

Exclusion Criteria:

• Requires concurrent ocular medication.

• Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.

• Clinically significant (Grade 3 or 4) corneal edema, corneal vascularisation, corneal staining, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.

• Diabetic.

• Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).

• Extended lens wear in last 3 months.

• PMMA or RGP lens wear in the previous 8 weeks.

• Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrollment for this study.

• Abnormal lacrimal secretions.

• Pre-existing ocular irritation that would preclude contact lens fitting.

• Keratoconus or other corneal irregularity.

• Pregnancy, lactating or planning a pregnancy at the time of enrollment.

• Participation in any concurrent clinical trial or in last 60 days."

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• etafilcon A
daily disposable contact lens
• ocufilcon D
daily disposable contact lens

Locations

Country	Name	City	State
n/a

Sponsors (3)

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

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comfort While Working on Computer	Comfort throughout the day was evaluated via subjective question: "Comfort while working on computer" and is reported as an aggregate of "Agree Strongly and Agree Somewhat".	1-week-follow-up
Primary	Lens Comfort	Lens comfort was evaluated via the subjective question: "How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided?" (excellent/very good=5...very good=3...Poor=0)	1-week follow-up
Secondary	Comfort Throughout the Whole Day	Comfort throughout the day was evaluated via subjective question: "Comfort throughout the whole day" and is reported as an aggregate of "Agree Strongly and Agree Somewhat".	1-week follow-up