N/A
N=88
Clinical Evaluation of a Daily Disposable Contact Lens in Symptomatic Weekly/Monthly Lens Wearers
Dry Eye Syndrome · Myopia
Bottom Line
View on ClinicalTrials.gov: NCT01614600 ↗Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: Mean Change From Baseline in Contact Lens-Related Dryness Symptoms at Week 1 and Week 2 — -0.09; -0.29 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nelfilcon A contact lenses (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Contact Lens-Related Dryness Symptoms at Week 1 and Week 2 |
-0.09; -0.29 | — |
Summary
The purpose of this study was to evaluate the reduction of contact lens-related dryness symptoms when symptomatic weekly/monthly contact lens wearers were switched to DAILIES® AquaComfort Plus® lenses for a two-week period using composite scores on the Contact Lens Dry Eye Questionnaire (CLDEQ).
Eligibility Criteria
Inclusion Criteria
- Currently wearing weekly/monthly, silicone hydrogel or traditional hydrogel soft contact lenses at least 8 hours per day and 5 days a week during the past 6 months.
- Identified as symptomatic using a baseline screening questionnaire.
- Requires vision correction in both eyes with a contact lens prescription as follows: sphere powers between -0.50 and -10.00 diopter (D) and cylinder powers </= 0.75D and no ADD correction.
- Able to achieve visual acuity (VA) of at least 6/7.5 in each eye with study lenses in the available parameters.
- Willing to wear study lenses for at least 8 hours/day and at least 5 days/week and discard the lenses at the end of the day and replace lenses every day with a new fresh pair.
- Willing and able to follow instructions and maintain the appointment schedule.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Neophytes and current wearers of daily disposable contact lenses.
- Requires monovision correction.
- Any systemic or ocular disease or disorder (refractive disorder allowed) complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
- A history of ocular surgery/trauma within the last 6 months.
- Unwilling to discontinue mechanical eyelid therapy or eyelid scrubs within 14 days of enrollment and continuing during the study.
- 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 (NCT01614600). 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.