Clinical trial NCT02196766: BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens
Official title: BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens: A Two Week Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2014-07-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: To determine if patients are unreactive to the lens care solution / Biofinity combination.

Detailed description: To determine if patients are unreactive to the lens care solution / Biofinity combination in this cross-over study.

Eligibility criteria: Inclusion Criteria:

* Is over 18 years of age (inclusive)
* Has had a self-reported visual exam in the last two years
* Is currently an adapted spherical soft CL wearer
* Has a CL spherical prescription between - 0.25 and - 12.00 (inclusive)
* Has less than 1.00D spectacle cylinder in each eye.
* Is correctable to a visual acuity of 20/20 or better in both eyes
* 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 40 hrs per week)
* 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 (5 days per week; \> 8 hours/day)
* Has a CL prescription outside the range of - 0.25 to -12.00D
* Has a spectacle cylinder greater than -0.75D of cylinder in either eye.
* Has best corrected spectacle distance vision worse than 20/20 in either eye.
* Has any systemic disease affecting ocular health.
* Is using any systemic or topical medications that will affect ocular health.
* 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 pregnant or lactating.
* Has undergone corneal refractive surgery.
* Is participating in any other type of eye related clinical or research study.

Primary outcomes:
measure: Ocular Health - Corneal Staining
timeFrame: 1 week
measure: Ocular Health - Conjunctival Redness
timeFrame: 1 week
measure: Ocular Health - Limbal Redness
timeFrame: 1 week
measure: Ocular Health - Papillary Conjunctivitis
timeFrame: 1 week
Secondary outcomes:
measure: Stinging Sensation Right After Insertion (Subjective Rating)
timeFrame: Baseline
measure: Burning Sensation Right After Insertion (Subjective Rating)
timeFrame: Baseline
Other outcomes:
Locations:
city: Joyo-shi
country: Japan
facility: Kokama Eye Clinic
state: Kyoto-fu
city: Kameoka
country: Japan
facility: Higashihara Clinic
state: Kyoto-fu
city: Shibuya-ku
country: Japan
facility: Dougenzaka Ioti Eye Clinic
state: Tokyo-to
Study officials:
affiliation: Director Professional Services, CVI Japan
name: Taku Muraoka, OD
role: STUDY_DIRECTOR
References: