Comparison of Two Marketed Lenses in a Controlled Environment

NCT ID: NCT02212301

Last Updated: 2016-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2014-12-31

Brief Summary

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

Conditions

Eye Dryness

Study Design

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

Study Groups

senofilcon A / lotrafilcon B

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.

Group Type: ACTIVE_COMPARATOR

senofilcon A

Intervention Type: DEVICE

Each study contact lens will be worn as daily wear modality for a period of 2 weeks each.

lotrafilcon B

Intervention Type: DEVICE

Each study contact lens will be worn as daily wear modality for a period of 2 weeks each.

lotrafilon B/ senofilcon A

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

Group Type: ACTIVE_COMPARATOR

senofilcon A

Intervention Type: DEVICE

Each study contact lens will be worn as daily wear modality for a period of 2 weeks each.

lotrafilcon B

Intervention Type: DEVICE

Each study contact lens will be worn as daily wear modality for a period of 2 weeks each.

Interventions

senofilcon A

Each study contact lens will be worn as daily wear modality for a period of 2 weeks each.

Intervention Type: DEVICE

lotrafilcon B

Each study contact lens will be worn as daily wear modality for a period of 2 weeks each.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

CR-5573

Identifier Type: -

Identifier Source: org_study_id