A Clinical Comparison of Two Daily Disposable Contact Lenses.

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00775021
• Other study ID #: CR-0814
• Secondary ID: ID08-34
• Status: Completed
• Phase: N/A
• Start date: August 2008
• Est. completion date: January 2009

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

The objective of this study is to evaluate the clinical performance of two daily disposable contact lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Age: 18 years to 45 years

• Current daily soft contact lens as habitual optical correction:

• Refraction:

• Best sphere (corrected for back vertex distance) -1.00 to -6.00D

• Cylinder 0.00 to - 0.75D

• Best spectacle corrected visual acuity of 6/9 or better in each eye

• Willingness to adhere to the instructions set in the clinical protocol

• Signature of the subject on the informed consent form

Exclusion Criteria:

• Systemic or ocular allergies which might interfere with contact lens wear

• Systemic disease which might interfere with contact lens wear

• Ocular disease which might interfere with contact lens wear (e.g. hypoesthesia, insufficient lacrimal secretion)

• Use of medication which might interfere with contact lens wear

• Active ocular infection

• Use of ocular medication

• Significant ocular anomaly

• Presence of two or more corneal scars in either eye

• Pregnancy or lactation

• Any medical condition that might be prejudicial to the study

• Participated in any other clinical studies in the past month

• Currently wears monovision

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• etafilcon A
Contact Lens
• nelfilcon A
Contact Lens

Locations

Country	Name	City	State
United Kingdom	Otometry Technology Group, Ltd.	London

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Comfort	Subjects rated study contact lens for overall comfort using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.	1 week
Secondary	Inferior Region Corneal Staining	The investigator assessed abrasion to the lower portion of the cornea using the following scale:0 = None 1 = Slight micropunctate (1-10 spots) 2 = Moderate micropunctate (11-20 spots) 3 = Severe micropunctate (>20 spots)4 = Slight macropunctate (1-5 spots) 5 = Moderate macropuntate (>5-10 spots) 6 = Severe macropunctate (>10 spots) 7 = Slight patch (1-2mm)8 = Moderate patch (>2-4mm) 9 = Severe patch (>4mm)	1 week
Secondary	End of the Day Comfort	Subjects rated study contact lens comfort at the end of a day of lens wear using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.	1 week
Secondary	Initial Comfort	Subjects rated study contact lens for comfort immediately when they first put the lenses on using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.	1 Week
Secondary	Overall Lens Handling	Subjects rated study contact lens for overall ease of handling using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.	1 week