Comparison of Two Marketed Lenses in a Controlled Environment

• ClinicalTrials.gov Identifier: NCT02212301
• Recruitment Status: Completed
• First Posted: August 8, 2014
• Results First Posted: September 27, 2016
• Last Update Posted: October 28, 2016
• Sponsor: Johnson & Johnson Vision Care, Inc.
• Information provided by (Responsible Party): Johnson & Johnson Vision Care, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Eye Dryness	Device: senofilcon A; Device: lotrafilcon B	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Study Start Date: July 2014
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: December 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Device: senofilcon A; Each study contact lens will be worn as daily wear modality for a period of 2 weeks each.; Device: lotrafilcon B; Each study contact lens will be worn as daily wear modality for a period of 2 weeks each.
Active Comparator: 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	Device: senofilcon A; Each study contact lens will be worn as daily wear modality for a period of 2 weeks each.; Device: lotrafilcon B; Each study contact lens will be worn as daily wear modality for a period of 2 weeks each.

Outcome Measures

Primary Outcome Measures :

1. Tear Film Kinetics [ Time Frame: 8 hour post insertion ]
   The non-invasive tear film break-up-time (NIBUT) is the time elapsed (in seconds) between eye opening after a blink, and the appearance of the first dark spot within the tear film when observed with the wide diffuse light source of the Tearscope. This measurement is indicative of the tear film stability and the on eye wettability of contact lenses.
2. Time Controlled Visual Acuity [ Time Frame: 8 hours post insertion ]
   The Time Controlled Visual Acuity test is a proprietary test part of MG Vision Advanced Visual Performance Assessment. The test for distance vision is carried out at 4m under high contrast and dim luminance. The test is presented on a fast response 17" LCD screen (1280 by 1064). The test for intermediate vision is carried out at 64cm under high contrast dim luminance. The test was presented on a fast response 13.3" LCD screen (3200 by 1800). Visual acuity will be measured in a controlled environment using logMAR units.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United Kingdom

London, United Kingdom, SW1E 6AU

Sponsors and Collaborators

Johnson & Johnson Vision Care, Inc.

More Information

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT02212301
• Other Study ID Numbers: CR-5573
• First Posted: August 8, 2014
• Results First Posted: September 27, 2016
• Last Update Posted: October 28, 2016
• Last Verified: September 2016