Clinical trial NCT02299869: Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs. Competitor) of Color Soft Contact Lenses.
Official title: Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs. Competitor) of Color Soft Contact Lenses.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2014-11-24
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs. Competitor)of Color Soft Contact Lenses

Detailed description: Each lens pair comparison will require two visits over two days, as follows: Visits: V1 (lens dispensing), V2 (20 minutes post lens settling). Each subject will be randomized to wear the test and control lenses in a series of four short fitting comparisons.

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.

Primary outcomes:
measure: Cosmetic Appearance Preference
timeFrame: 20 minutes
measure: Comfort
timeFrame: Baseline
measure: Comfort
timeFrame: 20 minutes
measure: Comfort Preference
timeFrame: Baseline
measure: Comfort Preference
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico D.F.
country: Mexico
facility: Optometry Clinic, National Autonomous University
Study officials:
affiliation: School of Optometry, National Autonomous University (UNAM), Mexico
name: Ruben Velazquez Guerrero, MSc FIACLE
role: PRINCIPAL_INVESTIGATOR
References: