Clinical Evaluation of Investigational Contact Lenses

Visual Acuity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02801396
• Other study ID #: CR-5759
• Status: Completed
• Phase: N/A
• First received: May 11, 2016
• Last updated: July 5, 2016
• Start date: April 2016
• Est. completion date: May 2016

Study information

• Verified date: July 2016
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Single-visit, unmasked, non-dispensing study where subjects will wear three different lenses bilaterally in one visit, each lens being worn for approximately 30-60 minutes. Subjects will complete a questionnaire for each study lens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Subjects must be at least 18 years of age and no more than 55 years of age (inclusive).

2. The subject's vertex corrected best spherical distance refraction must be in the range of -1.00 to -6.00 Diopters (D) in each eye.

3. The subject's vertex corrected cylindrical component of distance refraction must be less than or equal to -1.50 Diopters of Cylinder (DC) in each eye.

4. Subjects must have best corrected visual acuity of 20/25 (Snellen or equivalent) or better in each eye.

5. Subjects must self-report as being Asian race.

6. Subjects must self-report as having brown or black eyes.

7. Subjects must be habitual lens wearer (clear or limbal ring cosmetic) . Habitual is defined as at least one (1) month of Contact Lens wear where the lenses were worn for a minimum of six (6) hours per day and a minimum of three (3) days per week.

8. Subjects between 18 to 39 years old must be habitual limbal ring cosmetic lens wearers or must have tried limbal ring cosmetic lens within the past two years.

9. Subjects must be cosmetic contact lens concept acceptors as determined by screening questionnaire.

10. Subjects must possess a functional / usable pair of spectacles and bring them to the visit (only if applicable - to the investigator's discretion).

11. Subjects must read, understand, and sign the Statement of Informed Consent.

12. Subjects must appear able and willing to adhere to the instructions set forth in the clinical protocol.

13. Subjects must be willing to have their eyes video recorded and photographed.

Exclusion Criteria:

1. Working for any advertising agency, any company involved in public relations or marketing, market research; or any company that makes or sells contact lenses or glasses.

2. Participated in any paid market research within the past 3 months.

3. Pregnant or breast feeding a baby.

4. Subjects with diabetes.

5. Any ocular or systemic allergies or disease which might interfere with contact lens wear.

6. Any systemic disease, or autoimmune disease, which might interfere with contact lens wear, at investigator's discretion.

7. Using medications during and immediately preceding the study period that may interfere with current contact lens wear as determined by the investigators

8. Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report.

9. 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.

10. Any active ocular abnormalities/conditions that might interfere with contact lens wear (this includes, but not limited to, chalazia, recurrent styles, pterygium, infection etc.).

11. Any corneal distortion, scar, or opacity affecting vision as noted by subjects or investigators during examination.

12. History of any corneal surgery (e.g. radial keratotomy (RK), photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK)); confirmed with topography if necessary at the investigator's discretion.

13. Habitual wearers of rigid gas permeable or orthokeratology lens within the past 3 months.

14. Current habitual contact lens modality for extended wear or conventional wear (contact lenses with a replacement schedule of 3 months to >1 year).

15. Participation in any pharmaceutical, medical device, or contact lens related clinical research trial within 14 days prior to study enrollment. This excludes studies that do not require product treatment/intervention.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Visual Acuity

Intervention

Device:
• Etafilcon A Design 1 (Test 1)

• Etafilcon A Design 2 (Test 2)

• Etafilcon A (Control)

Locations

Country	Name	City	State
Hong Kong	Hong Kong Polytechnic University	Hong Hom	Kowloon

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mechanical lens Fit	Mechanical lens fit will be assessed for each subject and eye after 30-60 minutes of lens wear. Lens fit is a binary response and 'Yes' = Acceptable Fit and 'No' = Unacceptable Fit. Lens fit is assessed using Lens centration, limbal exposure, primary gaze movement, up-gaze movement, edge lift, lens tightness. Unacceptable fit will be declared if there is any of the following present: limbal exposure, edge lift, excessive movement in primary or up-gaze or insufficient movement in primary gaze and up-gaze. The percentage of subject eyes with acceptable lens fit will be reported.	During 30-60 minute wear	No
Primary	Cosmetic Lens Fit	Cosmetic Lens Fit will be assessed for each subject at 3 feet in primary and extreme gazes (temporal, nasal and up-gaze). Acceptable cosmetic lens fit is a binary response where 'Yes' = Acceptable Fit and 'No' = Unacceptable Fit. Acceptable cosmetic lens fit will be declared if the cosmetic pattern covers the outer iris/limbal ring area during the inter-blink completely (for all test positions). The percentage of subject eyes with acceptable cosmetic fit will be reported.	During 30-60 minute wear	No
Primary	Contact Lens Handling	CLUE Handling is assessed using the Contact Lens User Experience (CLUE™) Questionnaire. CLUE™ is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens-wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable / positive response. 97% of the scores fall within 0 and 120 (mean +/- 3XSD).	During 30-60 minute wear	No
Primary	Distance Visual Acuity (LogMAR)	Distance time controlled LogMAR Visual Acuity will be carried out binocularly with high luminance and high contrast, at 4m using an ETDRS chart. The average Visual Acuity (LogMAR) will be reported.	During 30-60 minute wear	No