Clinical trial NCT01464255: Comparative Study of Two Marketed 1-day Soft Contact Lenses
Official title: Clinical Performance of Ocufilcon D With a Wetting Agent to Ocufilcon B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: contact lenses
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2011-11-03
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

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

Primary outcomes:
measure: Lens Fit - Decentration After Insertion
timeFrame: Baseline and 7 days from baseline visit
measure: Lens Fit - Decentration at One Week
timeFrame: 7 days and 14 days from baseline visit
measure: Lens Fit - Tightness After Insertion
timeFrame: Baseline and 7 days from baseline visit
measure: Lens Fit - Tightness at One Week
timeFrame: 7 days and 14 days from baseline visit
measure: Lens Fit - Post-Blink Lens Movement After Insertion
timeFrame: Baseline and 7 days from baseline visit
measure: Lens Fit - Post-Blink Lens Movement Prior to Removal
timeFrame: 7 days and 14 days from baseline visit
Secondary outcomes:
measure: Overall Preference - Comfort After Insertion
timeFrame: 14 days from baseline visit
measure: Overall Preference - Comfort Before Removal
timeFrame: 14 days from baseline visit
measure: Overall Preference - Dryness After Insertion
timeFrame: 14 days from baseline visit
measure: Overall Preference - Dryness Before Removal
timeFrame: 14 days from baseline visit
measure: Overall Preference - Handling, Inserting
timeFrame: 14 days from baseline visit
measure: Overall Preference - Handling, Removing
timeFrame: 14 days from baseline visit
measure: Overall Lens Pair Preference
timeFrame: 14 days from baseline visit
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Clinical Research Center, U.C. Berkeley, School of Optometry
state: California
Study officials:
affiliation: U.C. Berkeley, School of Optometry
name: Thao N Yeh, OD
role: PRINCIPAL_INVESTIGATOR
References: