Two Week Cross-Over Study Comparing Two Daily Disposable Contact Lenses

NCT ID: NCT01155323

Last Updated: 2018-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-01
• Study Completion Date: 2010-06-01

Brief Summary

This study seeks to evaluate and compare the clinical performance of two daily disposable soft contact lenses, Proclear 1 Day and 1-Day Acuvue Moist.

Conditions

Myopia

Study Design

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

Study Groups

etafilcon A/omafilcon A

etafilcon A contact lenses will be worn during the first week and omafilcon A contact lenses will be worn during the second. Lenses were replaced daily

Group Type: ACTIVE_COMPARATOR

etafilcon A

Intervention Type: DEVICE

1-day soft contact lens

omafilcon A

Intervention Type: DEVICE

1-day soft contact lens

omafilcon A/etafilcon A

omafilcon A contact lenses will be worn during the first week and etafilcon A contact lenses will be worn during the second. Lenses were replaced daily.

Group Type: ACTIVE_COMPARATOR

etafilcon A

Intervention Type: DEVICE

1-day soft contact lens

omafilcon A

Intervention Type: DEVICE

1-day soft contact lens

Interventions

etafilcon A

1-day soft contact lens

Intervention Type: DEVICE

omafilcon A

1-day soft contact lens

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• At least 18 years of age and no more than 39 years of age
• Existing soft contact lens wearers
• Willing to signed a written Informed Consent.
• Own a mobile phone and are willing to receive and reply to Short Message Service (SMS) messages during the day.
• Have a contact lens spherical distance requirement between -1.00 diopters (D) and -6.00 diopters (D) in both eyes.
• Have an Astigmatism of 1.00D or less in both eyes.
• Require a visual correction in both eyes.
• Be correctable to a visual acuity of 6/9 (20/30) or better in each eye.
• Have normal eyes with no evidence of abnormality or disease that would preclude lens wear.

Exclusion Criteria

• Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, tarsal abnormalities, bulbar infection, or any other abnormality of the cornea that would contraindicate contact lens wear.
• Clinically significant corneal staining (Grade 3 in more than one region).
• Keratoconus or other corneal irregularity.
• Abnormal lachrymal secretions.
• Extended wear of contact lenses last 3 months.
• Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in the previous 8 weeks.
• Refractive surgery.
• Eye injury/surgery within 8 weeks immediately prior to enrollment for this study.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Require concurrent ocular medication
• Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
• Any infectious disease (e.g., hepatitis, tuberculosis) or any immunosuppressive disease (e.g., HIV).
• Diabetes.
• Pregnant, lactating or planning a pregnancy at the time of enrollment.
• Participation in any concurrent clinical trial or in last 30 days.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson K.K. Medical Company

INDUSTRY

Sponsor Role: collaborator

Visioncare Research Ltd.

OTHER

Sponsor Role: collaborator

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Danny Sim, Diploma in Optometry

Role: PRINCIPAL_INVESTIGATOR

Singapore Polytechnic

Locations

Singapore Plytechnic

Singapore, , Singapore

Countries

Singapore

Other Identifiers

DISP-523

Identifier Type: OTHER

Identifier Source: secondary_id

CR-0926

Identifier Type: -

Identifier Source: org_study_id