Impact of Soft Contact Lenses on Lid-Parallel Conjunctival Folds

NCT ID: NCT02164396

Last Updated: 2018-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2013-12-31

Brief Summary

The aim of the study is to investigate how Lid-Parallel Conjunctival Folds recovers or persists after the continued usage or discontinuation of contact lenses or refitting with low coefficient of friction lenses.

Conditions

Lid-Parallel Conjunctival Folds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Spectacles Lens

Participant will discontinue soft contact lens wear and wear spectacles only. Spectacle lens refers to the habitual prescription glasses that the participant arrives to the testing center with; they are NOT prescribed or given to the participant by the investigator as part of the study protocol.

Group Type: ACTIVE_COMPARATOR

Spectacle Lens

Intervention Type: DEVICE

Spectacle Lens Only

Habitual Soft Contact Lens

Participant will continue to wear their habitual soft contact lenses. Habitual lenses are the contact lenses used by the subjects prior to participating in the clinical trial. Various types/brands are used by subjects prior to participation.

Group Type: ACTIVE_COMPARATOR

Habitual Soft Contact Lens

Intervention Type: DEVICE

subject's own contact lens

Test Lens

Participants will be dispensed senofilcon A or narafilcon A depending on their habitual modality (reusable or daily disposable)

Group Type: EXPERIMENTAL

Test Lens

Intervention Type: DEVICE

senofilcon A or narafilcon A

Interventions

Spectacle Lens

Spectacle Lens Only

Intervention Type: DEVICE

Habitual Soft Contact Lens

subject's own contact lens

Intervention Type: DEVICE

Test Lens

senofilcon A or narafilcon A

Intervention Type: DEVICE

Eligibility Criteria

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 18 years old.

4. The subject's contact lens correction must be in the range of -12.00 to +8.00 in each eye.

5. The subject's refractive cylinder must be less than 1.50D in each eye.

6. The subject must have best visual acuity of 20/40 or better in each eye.

7. The subject must demonstrate adequate mobility and 20/40 vision OD and OS with their habitual contact lenses.

8. The subject must be an adapted soft contact lens wearer in both eyes with at least 1 year experience in contact lens wear.

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

10. The subject must have Lid-Parallel Conjunctival Folds greater than or equal to grade 1 OD or OS.

Exclusion Criteria

1. Currently self reported 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. This may include, but not be limited to, ocular/systemic pathology or allergy known to affect the conjunctiva, Sjogren's Syndrome, rheumatoid arthritis, diabetes, infections, hay-fever, or if they have had ocular surgery.

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

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

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

6. 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 abnormality that may contraindicate contact lens wear.

7. Any ocular infection.

8. Monovision or multi-focal contact lens correction.

9. Participation in any contact lens or lens care product clinical trial within 90 days prior to study enrollment.

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

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

12. Contact lens wearing of OASYS or TruEye lenses

13. Contact lens wearing time less than 6h/day and/or 5 days/week

14. Extended wear of contact lenses.

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Weinheim, , Germany

Countries

Germany

Other Identifiers

CR-005277

Identifier Type: -

Identifier Source: org_study_id