Assessment of Contact Lens Wettability Using Wavefront Aberrometry

NCT ID: NCT02349438

Last Updated: 2018-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-05-31

Brief Summary

This study will test the feasibility that differences in contact lens wettability can be measured with a wavefront sensor.

Conditions

Visual Acuity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

senofilcon A

The lenses will be worn for 2 hours in both eyes, and not dispensed

Group Type: EXPERIMENTAL

senofilcon A

Intervention Type: DEVICE

A soft spherical contact lens

lotrafilcon B

Intervention Type: DEVICE

lotrafilcon A

The lenses will be worn for 2 hours in both eyes, and not dispensed

Group Type: ACTIVE_COMPARATOR

senofilcon A

Intervention Type: DEVICE

A soft spherical contact lens

lotrafilcon B

Intervention Type: DEVICE

Interventions

senofilcon A

A soft spherical contact lens

Intervention Type: DEVICE

lotrafilcon B

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Healthy males or females that are at least 18 to no more than 40 years of age.

2. The subject must read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.

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

4. The subject must possess a wearable pair of spectacles with distance vision correction which provide satisfactory vision.

5. The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of lens wear per week for a minimum of 1 month prior to the study) or has sufficient prior experience with soft contact lens wear (defined as a minimum of 30 days of lens wear during the last 5 years).

6. The subject's vertexed best sphere distance refraction must be between -0.75 and -5.00 D in both eyes.

7. Cylinder refraction less than or equal to -0.75 D in both eyes (any axis).

8. The subject must have corrected visual acuity of 20/20 or better in each eye.

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. Any known hypersensitivity or allergic reaction to contact lens solutions or sodium fluorescein dye.

5. Any previous ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)

6. Current wearers of rigid or hybrid contact lenses.

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

8. Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).

9. History of binocular vision abnormality or strabismus.

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

11. Clinically significant (grade 3 or 4) corneal edema, pterygium, corneal vascularization, corneal staining, or any other abnormalities of the cornea or conjunctiva which may interfere with the study measurements.

12. Strabismus, suppression or amblyopia.

13. Any ocular infection.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kelvin Grove, Queensland, Australia

Countries

Australia

Other Identifiers

CR-5685

Identifier Type: -

Identifier Source: org_study_id