N/A
N=25
Lens Wear Schedules and End-of-Day Comfort
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT01433549 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcome: Primary: Mean End-of-Day Comfort — 48.9; 56.0; 51.4; 53.7 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lotrafilcon B (Device); Senofilcon A (Device)
- Age
- Pediatric, Adult, Older Adult · 17+ yrs
- Sex
- All
- Sponsor
- CIBA VISION
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean End-of-Day Comfort |
48.9; 56.0; 51.4; 53.7; 56.0; 58.8 | — |
| SECONDARY Mean Non-Invasive Tear Film Break-Up Time (NITBUT) |
4.6; 4.3; 5.3; 4.7; 4.4; 4.4 | — |
Summary
The purpose of this study was to assess the impact of lens-free (recovery) intervals of varying lengths on end-of-day comfort and tear film changes with daily contact lens wear.
Eligibility Criteria
Inclusion Criteria
- Is at least 17 years of age and has full legal capacity to volunteer.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Has had an ocular examination in the last two years.
- Is an adapted soft contact lens wearer.
- Experiences a decrease in ocular comfort through a lens-wearing day.
- Has a current pair of spectacles.
- Has a distance contact lens prescription of +6.00 diopters to -10.00 diopters and an acceptable fit with the study lenses.
- Has astigmatism less than or equal to -1.00 DC.
- Achieves visual acuity of 6/9 or better with the study lenses and with habitual spectacles.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Has any ocular disease.
- Has a systemic condition that may affect a study outcome variable.
- Is using any systemic or topical medications that may affect ocular health.
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01433549). 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.