- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02212301
Comparison of Two Marketed Lenses in a Controlled Environment
September 26, 2016 updated by: Johnson & Johnson Vision Care, Inc.
This study is comparing two silicone hydrogel contact lenses in a controlled environment for identification of characteristics associated to vision.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom, SW1E 6AU
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The subject must be 18 years of age and less than 51 years of age;
- The subject must have read and understood the Participant Information Sheet;
- The subject must have read, signed and dated the Informed Consent;
- The subject must be a current planned replacement soft contact lens wearer;
- 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
- The subject must have a refractive error within the range of correction of both study contact lenses;
- The subject must have a best-corrected visual acuity of 6/9 (20/30, 0.18 LogMAR) or better in each eye;
- The subject must demonstrate an acceptable fit with both study contact lenses;
- 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;
- The subject must have normal eyes with the exception of the need for visual correction.
Exclusion Criteria:
- Any known sensitivity or intolerance to any of the contact lenses or adjunct products to be used.
- Monocular vision (only one eye with functional vision or only one eye fitted with contact lenses).
- Use of systemic or ocular concomitant medications which, as determined by the investigator, might contraindicate or interfere with contact lens wear.
- Ocular anterior segment infection, inflammation, abnormality, or active disease, which would contraindicate contact lens wear.
- Any moderate or severe ocular condition observed during slit lamp examination at the enrollment visit.
- A history of herpetic keratitis, ocular surgery or irregular cornea(s).
- Known pregnancy or lactation during the study period.
- Enrollment of investigator's office staff, relatives, or members of their respective households.
- Participation in any clinical trial within 30 days of the enrollment visit.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / 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.
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Each study contact lens will be worn as daily wear modality for a period of 2 weeks each.
Each study contact lens will be worn as daily wear modality for a period of 2 weeks each.
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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
|
Each study contact lens will be worn as daily wear modality for a period of 2 weeks each.
Each study contact lens will be worn as daily wear modality for a period of 2 weeks each.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tear Film Kinetics
Time Frame: 8 hour post insertion
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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.
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8 hour post insertion
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Time Controlled Visual Acuity
Time Frame: 8 hours post insertion
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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.
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8 hours post insertion
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
August 7, 2014
First Submitted That Met QC Criteria
August 7, 2014
First Posted (Estimate)
August 8, 2014
Study Record Updates
Last Update Posted (Estimate)
October 28, 2016
Last Update Submitted That Met QC Criteria
September 26, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- CR-5573
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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