Clinical Evaluation of An Approved Contact Lens

Visual Acuity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02760810
• Other study ID #: CR-5815
• Status: Completed
• Phase: N/A
• First received: May 2, 2016
• Last updated: July 5, 2016
• Start date: April 2016
• Est. completion date: April 2016

Study information

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

Clinical Trial Summary

This is an 8-visit, bilateral, dispensing clinical study to evaluate the change in tear fluid pH and tear film osmolarity in an FDA-cleared contact lens in new contact lens users over a 14-day period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.

2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

3. The subject must be between 18 and 45 years of age.

4. The subject must have a valid spectacle prescription with expiration date not over 1 year.

5. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.25 Diopters (D) to -6.00 D in each eye.

6. The subject's refractive cylinder must be =1.00 Cylindrical Diopter (DC) in each eye.

7. The subject must have best corrected visual acuity of logMAR 0.20 or better in each eye.

8. Subjects should own a wearable pair of spectacles and agree to wear them the day of the initial visit and every morning on subsequent visit days.

9. The subject must be a contact lens neophyte, defined as never having been dispensed contact lenses, or who has taken part in a non-dispensing clinical study or has been fitted with contact lenses in practice but never went on to actually wear the lenses.

10. The subject must have normal eyes (i.e. no ocular medications or infections of any type).

Exclusion Criteria:

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).

2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.

3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.

4. Use of any medication with known tear film effects within 2 weeks prior to and during the study.

5. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion..

6. Any previous, or planned, ocular or interocular surgery (e.g. radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)

7. Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g. past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.

8. Any ocular infection.

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

10. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

11. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.

12. Employee of investigational clinic (e.g. Investigator, Coordinator, Technician).

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Visual Acuity

Intervention

Device:
• narafilcon A

Locations

Country	Name	City	State
United Kingdom	Aston University	Birmingham	West Midlands

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear pH	Tear PH will be assessed using a micro-combination pH probe (Thermo Scientific Orion Micro pH electrode) . The data will be collected at baseline and at 14 days post contact lens wear. Tear pH will be collected in 1 eye. The data will be collected from the same subject eye throughout the duration of the study. A change from baseline post 14 days of contact lens wear will be reported	Assessed up to 14 days	No
Primary	Osmolarity	Osmolarity will be assessed using the TearLab Osmolarity System. The data will be collected at baseline and at 14 days post contact lens wear. Osmolarity will be collected in 1 eye. The data will be collected from the same subject eye throughout the duration of the study. A change from baseline post 14 days of contact lens wear will be reported.	Assessed up to 14 days	No
Secondary	Tear pH	Tear PH will be assessed using a micro-combination pH probe (Thermo Scientific Orion Micro pH electrode) . The data will be collected at baseline and at 7 days post contact lens wear. Tear pH will be collected in 1 eye. The data will be collected from the same subject eye throughout the duration of the study. A change from baseline post 7 days of contact lens wear will be reported.	Assessed up to 7 days	No
Secondary	Osmolarity	Osmolarity will be assessed using the TearLab Osmolarity System. The data will be collected at baseline and at 7 days post contact lens wear. Osmolarity will be collected in 1 eye. The data will be collected from the same subject eye throughout the duration of the study. A change from baseline post 7 days of contact lens wear will be reported.	Assessed up to 7 days	No