N/A
N=49
Subjective Evaluation of a Commercially Marketed Contact Lens Amongst a Subset of the Contact Lens Wearing Population
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT01007916 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Feb 2011
Primary outcome: Primary: Comfort Upon Insertion — 8.7; 9.2 Units on a Scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lotrafilcon B contact lens (Device); Habitual contact lens (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- CIBA VISION
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comfort Upon Insertion |
8.7; 9.2 | — |
Summary
The purpose of this study is to compare the performance of commercially marketed contact lenses to habitual contact lenses in a selected segment of the contact lens wearing population.
Eligibility Criteria
Inclusion Criteria
- Habitual spherical soft contact lens wearer who wears a contact lens with a recommended replacement schedule of 2 weeks or monthly.
- Wears lenses at least 5 days per week and at least 12 hours per day.
- Removes contact lenses daily or, if prescribed by their regular eye care practitioner, sleeps overnight in contact lenses no more than 6 consecutive nights.
- Reports 2 or fewer common lens-related symptoms with current contact lenses with a frequency of "frequently" or "always".
- Able to achieve distance visual acuity of at least 20/40 in each eye at the dispense of each pair of study lenses.
- Has acceptable or optimal fit for each eye at the dispense of each pair of study lenses.
- Other protocol-defined inclusion/exclusion criteria may apply.
Exclusion Criteria
- Eye injury or surgery within twelve weeks prior to enrollment.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Currently enrolled in any clinical trial.
- Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
- Currently sleeping in contact lenses for more than 6 consecutive nights.
- Currently wearing daily disposable contact lenses and certain protocol-specified lens brands.
- Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01007916). 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.