Comparison of Two Marketed Lenses in a Controlled Environment

Johnson & Johnson (J&J)

Status: Completed

Conditions: Eye Dryness

Treatments: Device: senofilcon A; Device: lotrafilcon B

Study type: Interventional

Funder types: Industry

Identifiers

NCT02212301

CR-5573

Details and patient eligibility

About

This study is comparing two silicone hydrogel contact lenses in a controlled environment for identification of characteristics associated to vision.

Enrollment: 45 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. The subject must be 18 years of age and less than 51 years of age;
2. The subject must have read and understood the Participant Information Sheet;
3. The subject must have read, signed and dated the Informed Consent;
4. The subject must be a current planned replacement soft contact lens wearer;
5. The subject must be a regular user of devices (computer, tablet and/or smart phone) for a minimum average of 5 ± 1 hours per day in a typical week
6. The subject must have a refractive error within the range of correction of both study contact lenses;
7. The subject must have a best-corrected visual acuity of 6/9 (20/30, 0.18 LogMAR) or better in each eye;
8. The subject must demonstrate an acceptable fit with both study contact lenses;
9. The subject must agree to wear their contact lenses as directed for the duration of the study (every day or for at least a minimum of five days per week for a minimum of six hours per day and be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule;
10. The subject must have normal eyes with the exception of the need for visual correction.

Exclusion criteria

1. Any known sensitivity or intolerance to any of the contact lenses or adjunct products to be used.
2. Monocular vision (only one eye with functional vision or only one eye fitted with contact lenses).
3. Use of systemic or ocular concomitant medications which, as determined by the investigator, might contraindicate or interfere with contact lens wear.
4. Ocular anterior segment infection, inflammation, abnormality, or active disease, which would contraindicate contact lens wear.
5. Any moderate or severe ocular condition observed during slit lamp examination at the enrollment visit.
6. A history of herpetic keratitis, ocular surgery or irregular cornea(s).
7. Known pregnancy or lactation during the study period.
8. Enrollment of investigator's office staff, relatives, or members of their respective households.
9. Participation in any clinical trial within 30 days of the enrollment visit.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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45 participants in 2 patient groups

senofilcon A / lotrafilcon B

Active Comparator group

Description:

Subjects were randomized to one of two lens wear sequences. Subjects randomized to this sequence first wore the senofilcon A contact lens and then wore the lotrafilcon B contact lens.

Treatment:

Device: senofilcon A

Device: lotrafilcon B

lotrafilon B/ senofilcon A

Active Comparator group

Description:

Subjects were randomized to one of two lens wear sequences. Subjects randomized to this sequence first wore the lotrafilcon B contact lens and then wore the senofilcon A contact lens

Treatment:

Device: senofilcon A

Device: lotrafilcon B