Clinical Evaluation of Two Daily Disposable Contact Lenses

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

Study Overview

• Status: Completed
• Conditions: Refractive Error
• Intervention / Treatment: Device: etafilcon A; Device: ocufilcon D

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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."

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: etafilcon A / ocufilcon D; etafilcon A contact lens worn first daily disposable , ocufilcon D contact lens worn second daily disposable	Device: etafilcon A; daily disposable contact lens; Device: ocufilcon D; daily disposable contact lens
Other: oculfilcon D / etafilcon A; ocufilcon D contact lens worn first, etafilcon A contact lens worn second	Device: etafilcon A; daily disposable contact lens; Device: ocufilcon D; daily disposable contact lens
Other: ocufilcon D / ocufilcon D; ocufilcon D contact lens worn first and second	Device: ocufilcon D; daily disposable contact lens
Other: etafilcon A / etafilcon A; etafilcon A contact lens worn first and second	Device: etafilcon A; daily disposable contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.
• Collaborators: Visioncare Research Ltd.; Singapore Polytechnic University

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: September 29, 2008
• First Submitted That Met QC Criteria: June 18, 2010
• First Posted (Estimate): July 16, 2010

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CR-0706; PRO-518