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Comparison of Two Marketed Lenses in a Controlled Environment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

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.




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.



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212301


Locations
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United Kingdom
London, United Kingdom, SW1E 6AU
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.

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