N/A
N=30
BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT02196766 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Ocular Health - Corneal Staining — 38; 35; 18; 20 Eyes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bioclean First Care EX / comfilcon A (Other); Aosept Clearcare / comfilcon A (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Health - Corneal Staining |
38; 35; 18; 20; 4; 5 | — |
| PRIMARY Ocular Health - Conjunctival Redness |
40; 40; 20; 20; 0; 0 | — |
| PRIMARY Ocular Health - Limbal Redness |
49; 47; 11; 12; 0; 1 | — |
| PRIMARY Ocular Health - Papillary Conjunctivitis |
52; 51; 7; 8; 1; 1 | — |
| SECONDARY Stinging Sensation Right After Insertion (Subjective Rating) |
9.5; 9.4 | — |
| SECONDARY Burning Sensation Right After Insertion (Subjective Rating) |
9.5; 9.4 | — |
Summary
To determine if patients are unreactive to the lens care solution / Biofinity combination.
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.
Data sourced from ClinicalTrials.gov (NCT02196766). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.