Pre-Lens Tear Film Performance of Silicone Hydrogel Daily Disposable Contact Lenses
This study has been completed.
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01548833
First received: March 6, 2012
Last updated: June 29, 2012
Last verified: June 2012
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Purpose
The purpose of this study is to compare the pre-lens tear film stability of DAILIES TOTAL1® silicone hydrogel daily disposable contact lenses with that of two other silicone hydrogel daily disposable contact lenses.
| Condition | Intervention |
|---|---|
|
Myopia |
Device: Delefilcon A contact lens (DAILIES TOTAL1) Device: Narafilcon A contact lens (1-DAY ACUVUE TRUEYE) Device: Filcon II 3 contact lens (Clariti 1-day) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Pre-Lens Tear Film Performance of Silicone Hydrogel Daily Disposable Contact Lenses |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT) [ Time Frame: Day 7 ] [ Designated as safety issue: No ]Pre-Lens Non-Invasive Tear Break-Up Time will be assessed using a modified CA-1000 topographer. PL-NITBUT will be recorded at the first sign of mire distortion. An average of three measurements will be taken.
| Enrollment: | 39 |
| Study Start Date: | March 2012 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Clariti/TruEye/DT1
Participants will wear each brand of contact lenses in randomly assigned order for one week in a daily wear, daily disposable manner.
|
Device: Delefilcon A contact lens (DAILIES TOTAL1)
Silicone hydrogel, spherical contact lens for single use, daily disposable wear.
Other Name: DAILIES® TOTAL1™
Device: Narafilcon A contact lens (1-DAY ACUVUE TRUEYE)
Silicone hydrogel, spherical contact lens for single use, daily disposable wear.
Other Name: 1-DAY ACUVUE® TRUEYE™
Device: Filcon II 3 contact lens (Clariti 1-day)
Silicone hydrogel, spherical contact lens for single use, daily disposable wear
Other Name: Clariti™ 1-day
|
|
TruEye/Clariti/DT1
Participants will wear each brand of contact lenses in randomly assigned order for one week in a daily wear, daily disposable manner.
|
Device: Delefilcon A contact lens (DAILIES TOTAL1)
Silicone hydrogel, spherical contact lens for single use, daily disposable wear.
Other Name: DAILIES® TOTAL1™
Device: Narafilcon A contact lens (1-DAY ACUVUE TRUEYE)
Silicone hydrogel, spherical contact lens for single use, daily disposable wear.
Other Name: 1-DAY ACUVUE® TRUEYE™
Device: Filcon II 3 contact lens (Clariti 1-day)
Silicone hydrogel, spherical contact lens for single use, daily disposable wear
Other Name: Clariti™ 1-day
|
|
DT1/TruEye/Clariti
Participants will wear each brand of contact lenses in randomly assigned order for one week in a daily wear, daily disposable manner.
|
Device: Delefilcon A contact lens (DAILIES TOTAL1)
Silicone hydrogel, spherical contact lens for single use, daily disposable wear.
Other Name: DAILIES® TOTAL1™
Device: Narafilcon A contact lens (1-DAY ACUVUE TRUEYE)
Silicone hydrogel, spherical contact lens for single use, daily disposable wear.
Other Name: 1-DAY ACUVUE® TRUEYE™
Device: Filcon II 3 contact lens (Clariti 1-day)
Silicone hydrogel, spherical contact lens for single use, daily disposable wear
Other Name: Clariti™ 1-day
|
|
Clariti/DT1/TruEye
Participants will wear each brand of contact lenses in randomly assigned order for one week in a daily wear, daily disposable manner.
|
Device: Delefilcon A contact lens (DAILIES TOTAL1)
Silicone hydrogel, spherical contact lens for single use, daily disposable wear.
Other Name: DAILIES® TOTAL1™
Device: Narafilcon A contact lens (1-DAY ACUVUE TRUEYE)
Silicone hydrogel, spherical contact lens for single use, daily disposable wear.
Other Name: 1-DAY ACUVUE® TRUEYE™
Device: Filcon II 3 contact lens (Clariti 1-day)
Silicone hydrogel, spherical contact lens for single use, daily disposable wear
Other Name: Clariti™ 1-day
|
|
DT1/Clariti/TruEye
Participants will wear each brand of contact lenses in randomly assigned order for one week in a daily wear, daily disposable manner.
|
Device: Delefilcon A contact lens (DAILIES TOTAL1)
Silicone hydrogel, spherical contact lens for single use, daily disposable wear.
Other Name: DAILIES® TOTAL1™
Device: Narafilcon A contact lens (1-DAY ACUVUE TRUEYE)
Silicone hydrogel, spherical contact lens for single use, daily disposable wear.
Other Name: 1-DAY ACUVUE® TRUEYE™
Device: Filcon II 3 contact lens (Clariti 1-day)
Silicone hydrogel, spherical contact lens for single use, daily disposable wear
Other Name: Clariti™ 1-day
|
|
TruEye/DT1/Clariti
Participants will wear each brand of contact lenses in randomly assigned order for one week in a daily wear, daily disposable manner.
|
Device: Delefilcon A contact lens (DAILIES TOTAL1)
Silicone hydrogel, spherical contact lens for single use, daily disposable wear.
Other Name: DAILIES® TOTAL1™
Device: Narafilcon A contact lens (1-DAY ACUVUE TRUEYE)
Silicone hydrogel, spherical contact lens for single use, daily disposable wear.
Other Name: 1-DAY ACUVUE® TRUEYE™
Device: Filcon II 3 contact lens (Clariti 1-day)
Silicone hydrogel, spherical contact lens for single use, daily disposable wear
Other Name: Clariti™ 1-day
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Be of legal age of consent and sign written Informed Consent document, or if under legal age, have written consent of parent or guardian to participate.
- Require vision correction in both eyes.
- Wear either daily disposable contact lenses or weekly/monthly replacement contact lenses in powers between -0.50 and -10.00 diopters, cylinder ≤0.75 diopter, no ADD correction.
- Wear habitual contact lenses an average of 12-14 hours per day, at least 5 days per week.
- Willing and able to wear study contact lenses 16 hours per day.
- Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Currently wearing DAILIES TOTAL1®, 1-DAY ACUVUE® TRUEYE™, or Clariti™ 1day contact lenses.
- Require monovision correction.
- Any systemic or ocular disease or disorder (refractive disorder allowed and dry eye permitted), complicating factors, or structural abnormality that would negatively affect the conduct or outcome of the study.
- Ocular surgery/trauma within the last 6 months.
- Topical or systemic antibiotic use within 7 days of enrollment.
- Topical ocular or systemic corticosteroid use within 14 days of enrollment.
- Pregnant and nursing women.
- Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
- Other protocol-defined exclusion criteria may apply.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT01548833 History of Changes |
| Other Study ID Numbers: | A00924 |
| Study First Received: | March 6, 2012 |
| Last Updated: | June 29, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by Alcon Research:
|
myopia contact lenses Alcon DAILIES TOTAL1 |
Additional relevant MeSH terms:
|
Myopia Refractive Errors Eye Diseases |
ClinicalTrials.gov processed this record on May 22, 2013