Comparative Study of Two Marketed 1-day Soft Contact Lenses

NCT ID: NCT01464255

Last Updated: 2014-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2011-11-30

Brief Summary

This study is designed to evaluate ocufilcon D lens compared to ocufilcon B lens in a 1-week crossover, daily wear regimen.

Detailed Description

This study is designed to evaluate 2 daily disposable contact lenses that are both currently cleared for the USA market. Study of the ocufilcon D lens compared to the ocufilcon B lens in a 1-week crossover, daily wear regimen. The primary objective is the comparison of fitting characteristics. The secondary objective is the comparison of comfort, end of day comfort and dryness measures.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: SINGLE

Study Groups

ocufilcon D

Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.

Group Type: EXPERIMENTAL

ocufilcon B

Intervention Type: DEVICE

Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.

ocufilcon B

Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.

Group Type: ACTIVE_COMPARATOR

ocufilcon D

Intervention Type: DEVICE

Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.

Interventions

ocufilcon D

Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.

Intervention Type: DEVICE

ocufilcon B

Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.

Intervention Type: DEVICE

Other Intervention Names

oculfilcon D (Daily wear soft contact lens); oculfilcon B (Daily wear soft contact lens)

Eligibility Criteria

Inclusion Criteria

• Has had a self reported oculo-visual examination in the last two years.
• Is able to wear the study lenses for at least eight hours a day, seven days a week
• Aged 18-40 years and has full legal capacity as a volunteer
• Has a distance contact lens prescription from -0.25 and -6.00D inclusive
• Has spectacle astigmatism of < 1.00D in each eye
• Baseline vision of 20/20 best-corrected in each eye.
• Is correctable to at least 20/25 distance visual acuity with study contact lenses in each eye
• Has read and understood the consent form and willing to sign consent form
• Willing and able to follow participant instructions and attend the required study visits Has worn soft contact lenses for at least two weeks prior to the study (daily wear only).

Exclusion Criteria

• Currently wears contact lenses on an extended wear basis.
• Not a current or past wearer of the ocufilcon B 52% 1-day lenses.
• Has undergone anterior ocular surgery
• Is aphakic
• Has never worn contact lenses before
• Has any systemic disease which clinically contraindicates contact lenses
• Has active ocular disease or severe insufficiency of lacrimal secretion (dry eye)
• Use of systemic or topical medications that will affect ocular health or visual performance
• Slit lamp findings with a grading of greater than 1.0 using the grading scales in Appendix 3
• Not possible to achieve a satisfactory fit with the lens design used in the study
• Has keratoconus or other corneal irregularity
• Participating in another eye-related clinical trial
• Pregnant, lactating or planning a pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thao N Yeh, OD

Role: PRINCIPAL_INVESTIGATOR

U.C. Berkeley, School of Optometry

Locations

Clinical Research Center, U.C. Berkeley, School of Optometry

Berkeley, California, United States

Countries

United States

Other Identifiers

CV-OMC-01

Identifier Type: -

Identifier Source: org_study_id