Clinical trial NCT01990664: Clinical Evaluation of Lapsed Contact Lens Wearers Who Are Re-fit Into Senofilcon A Contact Lenses
Official title: A Multi-Center Clinical Evaluation of Lapsed Contact Lens Wearers Who Are Re-Fit Into Spherical or Toric Senofilcon A Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lapsed Contact Lens Wear
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-21
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is an open-label, multi-site study. The total number of subjects was 200. The duration of this study was approximately four weeks. The primary objective was to assess what percentage of lapsed contact wearers, who have discontinued use of their contact lenses for greater than six months can be successfully re-fit with senofilcon A, reusable 2-weekly replacement daily wear lenses (spherical and toric designs).


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 interested in wearing contact lenses.
4. The subject must be at least 18 years old or less than 40 years of age at the time of consent.
5. The subject's vertexed spherical cylindrical refraction must result in a contact lens prescription for each eye that is available in the investigator's choice of study contact lens material(s).
6. The subject must have best corrected visual acuity of 20/30 or better in each eye.
7. The subject must require visual correction in both eyes.
8. The subject must be a lapsed wearer (defined as, any non-contact lens wearer requiring optical correction who has been previously fitted in and has previously purchased contact lenses but has since discontinued contact lens wear for any reason more than 6 months prior to the time of consent).
9. 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. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion.
5. Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, photorefractive keratectomy (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 ocular abnormality tha may contraindicate contact lens wear.
7. Any ocular infection.
8. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
9. Participation in any contact lens or lens care trial within one year prior to study enrollment.
10. History of binocular vision abnormality or strabismus.
11. Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g., HIV), by self report.
12. Employee of the investigational clinic (i.e., Investigator, Coordinator, or Technician).

Primary outcomes:
measure: Proportion of Successfully Re-fitted Subjects
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
state: Florida
city: Saint Augustine
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Roswell
country: United States
state: Georgia
city: Bloomington
country: United States
state: Illinois
city: Raytown
country: United States
state: Missouri
city: Vestal
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Warwick
country: United States
state: Rhode Island
city: Memphis
country: United States
state: Tennessee
Study officials:
References: