Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs. Competitor) of Color Soft Contact Lenses.
1 other identifier
interventional
41
1 country
1
Brief Summary
Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs. Competitor)of Color Soft Contact Lenses
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 20, 2014
CompletedFirst Posted
Study publicly available on registry
November 24, 2014
CompletedResults Posted
Study results publicly available
August 24, 2016
CompletedMarch 10, 2017
January 1, 2017
Same day
November 20, 2014
July 25, 2016
January 30, 2017
Conditions
Outcome Measures
Primary Outcomes (5)
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
Comfort
Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent).
Baseline
Comfort
Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent).
20 minutes
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
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
Study Arms (4)
Group 1 - Verde (Competitor-control) vs. Green (CVI-test)
OTHEREach subject was randomized to wear the test and control lenses contralaterally.
Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)
OTHEREach subject was randomized to wear the test and control lenses contralaterally.
Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)
OTHEREach subject was randomized to wear the test and control lenses contralaterally.
Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)
OTHEREach subject was randomized to wear the test and control lenses contralaterally.
Interventions
contact lens
contact lens
contact lens
contact lens
contact lens
contact lens
contact lens
contact lens
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Optometry Clinic, National Autonomous University
Mexico City, Mexico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. Manager Global Medical Scientific Affairs
- Organization
- CooperVision
Study Officials
- PRINCIPAL INVESTIGATOR
Ruben Velazquez Guerrero, MSc FIACLE
School of Optometry, National Autonomous University (UNAM), Mexico
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2014
First Posted
November 24, 2014
Study Start
October 1, 2014
Primary Completion
October 1, 2014
Study Completion
November 1, 2014
Last Updated
March 10, 2017
Results First Posted
August 24, 2016
Record last verified: 2017-01