Back to resultsInitial Performance of a Modified Daily Disposable Contact Lens
Primary Purpose
Refractive Error
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Delefilcon A contact lenses with UV Absorber
Delefilcon A contact lenses
Sponsored by
About this trial
This is an interventional other trial for Refractive Error
Eligibility Criteria
Inclusion Criteria:
- Must sign an Informed Consent document;
- Current wearers of commercial DT1 lenses (for at least 3 months), with a minimum wearing time of 5 days per week and 8 hours per day;
- Spherical contact lens correction within the range of -2.00 to -4.00 Diopter (D) in both eyes;
- Manifest astigmatism less than or equal to 0.75 D (at screening);
- Best-corrected visual acuity (BCVA) greater than or equal to 20/25 in each eye (as determined by manifest refraction at screening);
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Eye injury in either eye within 12 weeks prior to study enrollment;
- Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear as determined by the Investigator;
- Use of systemic or ocular medications for which contact lens wear could be contraindicated, including topical ocular medications and lubrication drops that would require instillation during contact lens wear;
- History of herpetic keratitis;
- History of refractive surgery or irregular cornea;
- Pathologically dry eye that precludes contact lens wear;
- Concurrent participation (or within the previous 30 days) in a contact lens or lens care product clinical trial;
- Monocular (only 1 eye with functional vision);
- Other protocol-specified exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DT1 UV
DT1
Arm Description
Delefilcon A contact lenses with Ultraviolet (UV) Absorber worn bilaterally (in both eyes) for 9 hours
Delefilcon A contact lenses worn bilaterally for 9 hours
Outcomes
Primary Outcome Measures
Incidence (Number) of Ocular Discomfort Device-related Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Reported in units of eyes.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02694835
Brief Title
Initial Performance of a Modified Daily Disposable Contact Lens
Official Title
Initial Performance of a Modified Daily Disposable Silicone Hydrogel Contact Lens
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 21, 2016 (Actual)
Primary Completion Date
April 11, 2016 (Actual)
Study Completion Date
April 11, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the incidence of ocular discomfort device-related adverse events with DAILIES TOTAL1® with UV Absorber (DT1 UV) contact lenses compared with current DAILIES TOTAL1® (DT1) contact lenses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DT1 UV
Arm Type
Experimental
Arm Description
Delefilcon A contact lenses with Ultraviolet (UV) Absorber worn bilaterally (in both eyes) for 9 hours
Arm Title
DT1
Arm Type
Active Comparator
Arm Description
Delefilcon A contact lenses worn bilaterally for 9 hours
Intervention Type
Device
Intervention Name(s)
Delefilcon A contact lenses with UV Absorber
Other Intervention Name(s)
DAILIES TOTAL1® UV (DT1 UV)
Intervention Type
Device
Intervention Name(s)
Delefilcon A contact lenses
Other Intervention Name(s)
DAILIES TOTAL1® (DT1)
Primary Outcome Measure Information:
Title
Incidence (Number) of Ocular Discomfort Device-related Adverse Events (AEs)
Description
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Reported in units of eyes.
Time Frame
Day 1 at Hour 9 ± 3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must sign an Informed Consent document;
Current wearers of commercial DT1 lenses (for at least 3 months), with a minimum wearing time of 5 days per week and 8 hours per day;
Spherical contact lens correction within the range of -2.00 to -4.00 Diopter (D) in both eyes;
Manifest astigmatism less than or equal to 0.75 D (at screening);
Best-corrected visual acuity (BCVA) greater than or equal to 20/25 in each eye (as determined by manifest refraction at screening);
Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
Eye injury in either eye within 12 weeks prior to study enrollment;
Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear as determined by the Investigator;
Use of systemic or ocular medications for which contact lens wear could be contraindicated, including topical ocular medications and lubrication drops that would require instillation during contact lens wear;
History of herpetic keratitis;
History of refractive surgery or irregular cornea;
Pathologically dry eye that precludes contact lens wear;
Concurrent participation (or within the previous 30 days) in a contact lens or lens care product clinical trial;
Monocular (only 1 eye with functional vision);
Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Manager, GCRA
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Initial Performance of a Modified Daily Disposable Contact Lens
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