Back to resultsDaily Disposable Contact Lens Tear Film Study
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
delefilcon A contact lens
narafilcon A contact lens
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Be of legal age of consent and sign Informed Consent document.
- Willing and able to wear spherical contact lenses for 16 hours.
- Willing and able to wear spherical contact lenses within the available range of powers.
- Best corrected spectacle visual acuity equal or better than 20/25 or 6/7.5.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Anterior segment infection, inflammation, or abnormality.
- Any use of systemic medications for which contact lens wear could be contraindicated.
- History of refractive surgery or irregular cornea.
- Currently enrolled in any clinical trial.
- Eye injury within twelve weeks prior to enrollment.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Aston University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
delefilcon A
narafilcon A
Arm Description
Delefilcon A randomly assigned to one eye, with narafilcon A assigned to the fellow eye for contralateral wear. Both products will be worn for one day for 16 hours (+/- 1 hour).
Narafilcon A randomly assigned to one eye, with delefilcon A assigned to the fellow eye for contralateral wear. Both products will be worn for one day for 16 hours (+/- 1 hour).
Outcomes
Primary Outcome Measures
Number of Participants With Corrected Visual Acuity of 0.0 or Better
Corrected visual acuity was measured with a digitized logMAR (logarithm of the minimum angle of resolution) chart. A logMAR acuity of 0.0 is considered normal distance eyesight.
Pre-Lens Noninvasive Tear Break-Up Time
The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a lengthening in the tear film break up time.
Average Tear Meniscus Height
The tear meniscus height, i.e., the distance between the line of reflection along the top of the tear prism to the edge of the eyelid, was measured by the investigator using a digital slit lamp.
Average Ocular Surface Temperature
Ocular surface temperature (OST) was recorded by the investigator using a dynamic, non-contact, infrared thermography camera. The average OST (encompassing the wear of a contact lens) was taken at the center of the cornea, at the temporal upper limbal area, and over the central 5 mm2 of the cornea, 2 seconds post-blink.
Secondary Outcome Measures
Subjective Comfort
Overall comfort was assessed by the participant and recorded on a scale from 0 (poor) to 10 (excellent) in response to the question, "How comfortable is the lens feeling at present?"
Subjective Vision
Overall vision was assessed by the participant on scale from 0 (poor) to 10 (excellent) in response to the question, "What is the quality of your vision with the lens at present?"
Number of Participants With Adequate Lens Fit
Lens fit was assessed by the investigator with a biomicroscope (slit lamp).
Full Information
NCT ID
NCT01473160
First Posted
November 14, 2011
Last Updated
April 16, 2013
Sponsor
CIBA VISION
Collaborators
Aston University
1. Study Identification
Unique Protocol Identification Number
NCT01473160
Brief Title
Daily Disposable Contact Lens Tear Film Study
Official Title
DAILIES TOTAL1 Pre-Lens Tear Film Performance - Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CIBA VISION
Collaborators
Aston University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to evaluate the pre-lens tear film stability of a new CE-marked daily disposable contact lens as compared to a commercially available daily disposable contact lens.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
delefilcon A
Arm Type
Experimental
Arm Description
Delefilcon A randomly assigned to one eye, with narafilcon A assigned to the fellow eye for contralateral wear. Both products will be worn for one day for 16 hours (+/- 1 hour).
Arm Title
narafilcon A
Arm Type
Active Comparator
Arm Description
Narafilcon A randomly assigned to one eye, with delefilcon A assigned to the fellow eye for contralateral wear. Both products will be worn for one day for 16 hours (+/- 1 hour).
Intervention Type
Device
Intervention Name(s)
delefilcon A contact lens
Other Intervention Name(s)
DAILIES TOTAL1
Intervention Description
CE-marked, silicone hydrogel, single vision, soft contact lens for daily disposable wear
Intervention Type
Device
Intervention Name(s)
narafilcon A contact lens
Other Intervention Name(s)
1-DAY ACUVUE TruEye
Intervention Description
Commercially marketed, silicone hydrogel, single vision, soft contact lens for daily disposable wear.
Primary Outcome Measure Information:
Title
Number of Participants With Corrected Visual Acuity of 0.0 or Better
Description
Corrected visual acuity was measured with a digitized logMAR (logarithm of the minimum angle of resolution) chart. A logMAR acuity of 0.0 is considered normal distance eyesight.
Time Frame
Up to 16 hours after lens insertion
Title
Pre-Lens Noninvasive Tear Break-Up Time
Description
The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a lengthening in the tear film break up time.
Time Frame
Up to 16 hours after lens insertion
Title
Average Tear Meniscus Height
Description
The tear meniscus height, i.e., the distance between the line of reflection along the top of the tear prism to the edge of the eyelid, was measured by the investigator using a digital slit lamp.
Time Frame
Up to 16 hours after lens insertion
Title
Average Ocular Surface Temperature
Description
Ocular surface temperature (OST) was recorded by the investigator using a dynamic, non-contact, infrared thermography camera. The average OST (encompassing the wear of a contact lens) was taken at the center of the cornea, at the temporal upper limbal area, and over the central 5 mm2 of the cornea, 2 seconds post-blink.
Time Frame
Up to 16 hours after lens insertion
Secondary Outcome Measure Information:
Title
Subjective Comfort
Description
Overall comfort was assessed by the participant and recorded on a scale from 0 (poor) to 10 (excellent) in response to the question, "How comfortable is the lens feeling at present?"
Time Frame
Up to 16 hours after lens insertion
Title
Subjective Vision
Description
Overall vision was assessed by the participant on scale from 0 (poor) to 10 (excellent) in response to the question, "What is the quality of your vision with the lens at present?"
Time Frame
Up to 16 hours after lens insertion
Title
Number of Participants With Adequate Lens Fit
Description
Lens fit was assessed by the investigator with a biomicroscope (slit lamp).
Time Frame
Up to 16 hours after lens insertion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be of legal age of consent and sign Informed Consent document.
Willing and able to wear spherical contact lenses for 16 hours.
Willing and able to wear spherical contact lenses within the available range of powers.
Best corrected spectacle visual acuity equal or better than 20/25 or 6/7.5.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Anterior segment infection, inflammation, or abnormality.
Any use of systemic medications for which contact lens wear could be contraindicated.
History of refractive surgery or irregular cornea.
Currently enrolled in any clinical trial.
Eye injury within twelve weeks prior to enrollment.
Other protocol-defined exclusion criteria may apply.
Facility Information:
Facility Name
Aston University
City
Birmingham
ZIP/Postal Code
B4 7ET
Country
United Kingdom
12. IPD Sharing Statement
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Daily Disposable Contact Lens Tear Film Study
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