N/A
N=39
Pre-Lens Tear Film Performance of Silicone Hydrogel Daily Disposable Contact Lenses
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT01548833 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Jun 2013
Primary outcome: Primary: Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT) — 13.56; 12.0; 11.86 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Delefilcon A contact lens (Device); Narafilcon A contact lens (Device); Filcon II 3 contact lens (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT) |
13.56; 12.0; 11.86 | — |
Summary
The purpose of this study was 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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01548833). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.