Comparative Study of Two Marketed 1-day Soft Contact Lenses

CooperVision

Status: Completed

Conditions: Myopia

Treatments: Device: ocufilcon D; Device: ocufilcon B

Study type: Interventional

Funder types: Industry

Identifiers

NCT01464255

CV-OMC-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 71 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

71 participants in 2 patient groups

ocufilcon D

Experimental group

Description:

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

Treatment:

Device: ocufilcon B

ocufilcon B

Active Comparator group

Description:

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

Treatment:

Device: ocufilcon D