N/A
N=40
Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs. Competitor) of Color Soft Contact Lenses.
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT02299869 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Cosmetic Appearance Preference — 8; 9; 4; 5 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Verde (Competitor-control) (Device); Green (CVI-test) (Device); Cinza (Competitor-control) (Device); Grey (CVI-test) (Device); Esmeralda (Competitor-control) (Device); Jade (CVI-test) (Device); Azul (Competitor-control) (Device); Blue (CVI-test) (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cosmetic Appearance Preference |
8; 9; 4; 5; 2; 1 | — |
| PRIMARY Comfort |
9.3; 8.3; 8.6; 8.1; 7.5; 8.0 | — |
| PRIMARY Comfort |
9.3; 8.3; 8.6; 8.1; 7.5; 8.0 | — |
| PRIMARY Comfort Preference |
8; 4; 4; 4; 2; 6 | — |
| PRIMARY Comfort Preference |
8; 4; 4; 4; 2; 6 | — |
Summary
Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs. Competitor)of Color Soft Contact Lenses
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 wearer of spherical soft contact lenses.
- Has a contact lens spherical prescription between - 1.00 and - 10.00 (inclusive).
- Has a spectacle cylinder up to 0.75 diopter (D) in each eye
- Can achieve best corrected spectacle distance visual acuity of 20/30 (0.18 logMAR) or better in each eye.
- Has clear corneas and no active ocular disease.
- Has read, understood and signed the information consent letter.
- Is willing to wear his/hers spectacles over the study contact lenses.
- Is willing to comply with the wear schedule.
- 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 contact lens wear (5 days per week; > 8 hours/day)
- Has a contact lens prescription outside the range of - 1.00 to -10.00D.
- Has a spectacle cylinder ≥1.00D of cylinder in either eye.
- Does not have a pair of corrective spectacles at the time of the visit.
- Cannot achieve best corrected spectacle distance visual acuity of 20/30 (0.18 logMAR) or better in each eye.
- Presence of clinically significant (grade > 2.0, scale 0-4) anterior segment abnormalities.
- Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
- Slit lamp findings that would contraindicate contact lens wear such as:
- Pathological dry eye or associated findings
- Pterygium, pinguecula, or corneal scars within the visual axis
- Neovascularization > 0.75 mm in from of the limbus
- Giant papillary conjunctivitis (GCP) worse than grade 1
- Anterior uveitis or iritis (past or present)
- Seborrheic eczema, Seborrheic conjunctivitis
- History of corneal ulcers or fungal infections
- Poor personal hygiene
- Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
- Has aphakia, keratoconus or a highly irregular cornea.
- Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
- Has undergone corneal refractive surgery.
- Is participating in any other type of eye related clinical or research study.
Data sourced from ClinicalTrials.gov (NCT02299869). 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.