N/A
N=62
A Prospective Study of Two Daily Disposable Contact Lenses
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT01636986 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: Primary: Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ — -0.21; -0.17; -1.07; -0.92 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Delefilcon A contact lenses (Device); Etafilcon A contact lenses (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ |
-0.21; -0.17; -1.07; -0.92; -0.04; -0.04 | — |
Summary
The purpose of this study was to evaluate the performance of a novel silicone hydrogel contact lens, DAILIES TOTAL1® (DT1) compared to the standard hydrogel material in 1-DAY ACUVUE® MOIST® (1DAVM) contact lens in contact lens wearers identified as having contact lens-related dryness symptoms.
Eligibility Criteria
Inclusion Criteria
- Be of legal age of consent and sign written Informed Consent Document and HIPAA form.
- Currently wearing soft contact lenses and identified as having contact lens-related dryness symptoms based upon responses to the Contact Lens Dry Eye Questionnaire.
- Wearing either daily disposable contact lenses or bi-weekly/monthly replacement contact lenses, daily wear use only (no extended wear use).
- Able to achieve distance visual acuity of at least 20/25 in each eye with study lenses in the available parameters, -0.50D to -6.00D.
- Willing to wear study lenses for at least 8 hours/day and at least 5 days/week.
- Willing and able to follow instructions and maintain the appointment schedule.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Neophyte or current wearer of DAILIES TOTAL1® or 1-DAY ACUVUE® MOIST™ contact lenses.
- Requires monovision or presbyopic correction.
- Any systemic or ocular disease or disorder complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
- Recent (within 7 days of enrollment) or current ocular infection, active ocular inflammation, glaucoma or preauricular lymphadenopathy.
- Clinically significant lash or lid abnormality.
- Systemic disease that, in the investigator's best judgment, would prohibit or confound safe contact lens wear.
- History of ocular surgery/trauma within the last 6 months.
- Topical or systemic antibiotics use within 7 days of enrollment.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01636986). 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.