Clinical trial NCT02097030: Clinical Evaluation of Daily Disposable Contact Lenses
Official title: Single-Center Clinical Evaluation of Daily Disposable Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2014-03-26
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The objective of the study is to compare the overall subjective preference of filcon II 3 daily disposable silicone hyrogel contact lenses compared to etafilcon A and nelfilcon A daily disposable conventional hydrogel contact lenses.

Detailed description: Double-masked, randomised, controlled crossover trial. Subjects were randomized to wear one or the other of the conventional hydriogel lenses; all subjects wore the filcon II 3 lenses. The first randomly assigned lens type was worn for 3 days, with daily replacement, followed by 3 days of wear of the other lens type, with daily replacement.

Eligibility criteria: Inclusion Criteria:

* Is between 18 and 40 years of age (inclusive)
* Has had a self-reported visual exam in the last two years
* Is an adapted soft CL wearer
* Must be able to wear their lenses at least 3 full days, 10 hours per day, assuming there are no contraindications for doing so
* Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
* Has less than 1.25 D spectacle cylinder in each eye.
* Baseline vision of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
* Is correctable to at least 20/25 distance visual acuity with study contact lenses in each eye
* Has clear corneas and no active ocular disease
* Has read, understood and signed the information consent letter
* Is willing to comply with the wear schedule (at least 3 full days)
* Is willing to comply with the visit schedule

Exclusion Criteria:

* Has never worn contact lenses before.
* Currently wears rigid gas permeable contact lenses.
* Has a history of not achieving comfortable CL wear (3 days per week; \> 8 hours/day)
* Has a CL prescription outside the range of - 1.00 to -6.00D
* Has a spectacle cylinder greater than -1.25D of cylinder in either eye.
* Has best corrected spectacle distance vision worse then 20/25 in either eye.
* Has any systemic disease affecting ocular health.
* Is using any systemic or topical medications, (includes rewetting drops, artificial tears and allergy drops), that will affect ocular health. Occasional use is acceptable but not during the trial.
* Has any ocular pathology or severe insufficiency of lacrimal secretion
* Has persistent, clinically significant corneal or conjunctival staining
* Has active neovascularization or any central corneal scars.
* Is aphakic.
* Is presbyopic.
* Has undergone corneal refractive surgery.
* Is participating in any other type of eye related clinical or research study.

Primary outcomes:
measure: Overall Lens Preference - All Study Lenses
timeFrame: Study Exit
measure: Overall Lens Preference - Hydrogel vs. Filcon II 3
timeFrame: Study Exit
Secondary outcomes:
measure: Subjective Response for Comfort
timeFrame: Baseline and 3 day follow-up
measure: Subjective Response for Vision
timeFrame: Baseline and 3 day follow-up
measure: Subjective Response for Insertion
timeFrame: Baseline
measure: Subjective Response for Handling (Insertion and Removal)
timeFrame: 3 days follow-up
measure: Subjective Response for Dryness
timeFrame: 3 Days Follow-up
measure: Overall Satisfaction, Vision
timeFrame: 3 Days Follow-up
measure: Overall Satisfaction, Comfort
timeFrame: 3 Days Follow-up
measure: Overall Satisfaction, Handling
timeFrame: 3 Days
measure: Overall Satisfaction, Dryness
timeFrame: 3 Days Follow-up
measure: Overall Satisfaction
timeFrame: 3 Days Follow-up
measure: Lens Fit and Performance - Wettability (Baseline and 3 Days Follow-up)
timeFrame: Baseline and 3 days follow-up
measure: Lens Fit and Performance - Deposits (Baseline and 3 Days Follow-up)
timeFrame: Baseline and 3 days follow-up
measure: Lens Fit and Performance - Debris (Baseline and 3 Day Follow-up)
timeFrame: Baseline and 3 day follow-up
measure: Lens Fit and Performance - Movement (Baseline and 3 Days Follow-up)
timeFrame: Baseline and 3 days follow-up
measure: Lens Fit and Performance - Fit Acceptance
timeFrame: Baseline and 3 day follow-up
measure: Lens Fit and Performance - Tightness (Baseline and 3 Day Follow-up)
timeFrame: Baseline and 3 day follow-up
measure: Ocular Health - Biomicroscopy
timeFrame: 3 Days Follow-up
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: University of California, Berkeley Clinical Research Center (UCB-CRC)
state: California
Study officials:
affiliation: University of California, Berkeley
name: Meng C Lin, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References: