Clinical Evaluation of Two Daily Disposable Contact Lenses

NCT ID: NCT01163760

Last Updated: 2018-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2007-09-30

Brief Summary

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

Conditions

Refractive Error

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

etafilcon A / ocufilcon D

etafilcon A contact lens worn first daily disposable , ocufilcon D contact lens worn second daily disposable

Group Type: OTHER

etafilcon A

Intervention Type: DEVICE

daily disposable contact lens

ocufilcon D

Intervention Type: DEVICE

daily disposable contact lens

oculfilcon D / etafilcon A

ocufilcon D contact lens worn first, etafilcon A contact lens worn second

Group Type: OTHER

etafilcon A

Intervention Type: DEVICE

daily disposable contact lens

ocufilcon D

Intervention Type: DEVICE

daily disposable contact lens

ocufilcon D / ocufilcon D

ocufilcon D contact lens worn first and second

Group Type: OTHER

ocufilcon D

Intervention Type: DEVICE

daily disposable contact lens

etafilcon A / etafilcon A

etafilcon A contact lens worn first and second

Group Type: OTHER

etafilcon A

Intervention Type: DEVICE

daily disposable contact lens

Interventions

etafilcon A

daily disposable contact lens

Intervention Type: DEVICE

ocufilcon D

daily disposable contact lens

Intervention Type: DEVICE

Eligibility Criteria

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."

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Singapore Polytechnic University

UNKNOWN

Sponsor Role: collaborator

Visioncare Research Ltd.

OTHER

Sponsor Role: collaborator

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Singapore, , Singapore

Countries

Singapore

Other Identifiers

PRO-518

Identifier Type: -

Identifier Source: secondary_id

CR-0706

Identifier Type: -

Identifier Source: org_study_id