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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02299869
• Other study ID #: EX-MKTG-51
• Status: Completed
• Phase: N/A
• First received: November 20, 2014
• Last updated: August 22, 2016
• Start date: October 2014
• Est. completion date: November 2014

Study information

• Verified date: August 2016
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Verde (Competitor-control)
contact lens
• Green (CVI-test)
contact lens
• Cinza (Competitor-control)
contact lens
• Grey (CVI-test)
contact lens
• Esmeralda (Competitor-control)
contact lens
• Jade (CVI-test)
contact lens
• Azul (Competitor-control)
contact lens
• Blue (CVI-test)
contact lens

Locations

Country	Name	City	State
Mexico	Optometry Clinic, National Autonomous University	Mexico D.F.

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cosmetic Appearance Preference	Participant's subjective preference for cosmetic appearance. 3 point Likert Scale. 1=prefer CVI-test lens 2=prefer Competitor-control lens, 3=no preference	20 minutes	No
Primary	Comfort	Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent).	Baseline	No
Primary	Comfort	Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent).	20 minutes	No
Primary	Comfort Preference	Participant's subjective preference for comfort on a 3 point Likert Scale. 1=prefer CVI-test lens, 2=prefer Competitor-control lens, 3=no preference	Baseline	No
Primary	Comfort Preference	Participant's subjective preference for comfort on a 3 point Likert Scale. 1=prefer CVI-test lens, 2=prefer Competitor-control lens, 3=no preference	20 minutes	No