Clinical trial NCT02173535: Quantitative Study of New Limbal Ring Prototypes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cosmetic Effect
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-25
Enrollment: 257
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The study is designed to test five new soft contact lens color pattern variants to determine whether the test lens makes the wearers eyes look bigger, more defined or enhances their overall appearance.


Eligibility criteria: Inclusion Criteria:

1. The subject must be at least 18 years of age and no more than 39 years of age (inclusive)
2. Subjects must be Asian female
3. Subjects must be able to read Chinese
4. Subjects' monthly household income must be above HKD$ 10,000
5. Subjects must be habitual soft contact lens wearer or habitual limbal lens wearer or have a history of previous habitual lens wear.
6. Subjects' current/previous habitual lens must be in the disposable soft lens modality (ranging from daily to monthly)
7. Subjects must have dark colored iris (black, brown, or brown hazel)
8. Subjects must be "concept acceptors". Concept acceptors are subjects that are willing to try new circle contact lenses.
9. Subjects must be classified as either 'Classic' or 'Vogue' on a Pattern Evaluation Screening Questionnaire.
10. Subjects must have acceptable near vision (without vision correction) and be able to see the test article lenses in the mirror 30 cm or closer.
11. Subjects must have best corrected visual acuity of 20/40 (Snellen or equivalent) or better in each eye.
12. Subjects must possess a functional/usable pair of spectacles and bring them to the visit (only if applicable-to the investigators discretion)
13. Subjects must read, understand, and sign the Statement of Informed Consent
14. Subjects must appear able and willing to adhere to the instructions set forth in this clinical protocol

Exclusion Criteria:

1. Subjects, or subjects' family member within the same household, that work for the following entities/companies: Government, advertising, marketing research or consultancy, media or public relations, companies that make, distribute or sell eyewear or contact lenses, eyecare practice (optometrist, ophthalmologist, optician) or the research center conducting the study
2. Habitual wearers of rigid gas permeable lenses within the last 3 months
3. Habitual soft conventional contact lens wearers (conventional lenses defined as replacement modality of greater than 1 month)
4. Any color deficiencies, by self report
5. Currently pregnant or breast-feeding a baby
6. Diabetes
7. Any ocular or systemic allergies or diseases which may interfere with contact lens wear
8. Any systemic disease, autoimmune disease, or use of medication which may interfere with contact lens wear, at the investigator's discretion
9. Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self report
10. Any grade 3 or greater Biomicroscopy findings (this includes, corneal edema, corneal staining, corneal vascularization, conjunctival injection, tarsal abnormalities, bulbar injection) on the FDA classification scale
11. Any active ocular abnormalities/conditions that may interfere with contact lens wear (this includes, but not limited to, chalazia, recurrent styes, pterygium, infection, etc.)
12. Any corneal distortion or moderate or above corneal distortion by self report
13. History of any corneal refractive surgery
14. Habitual contact lens is multifocal, monovision or worn as extended wear

Primary outcomes:
measure: Number of Subject in Agreement (Bigger Eyes)
timeFrame: 15-20 Minutes Post Lens Insertion
measure: Number of Subject in Agreement (Defines Eyes)
timeFrame: 15-20 Minutes Post Lens Insertion
measure: Number of Subject in Agreement (Enhance Eyes)
timeFrame: 15-20 Minutes Post Lens Insertion
Secondary outcomes:
Other outcomes:
Locations:
city: Hung Hom
country: Hong Kong
state: Kowloon
Study officials:
References: