N/A
N=117
Prospective Study of Lens Performance of a Monthly Replacement Lens at Two Weeks and Four Weeks
Myopia · Astigmatism · Presbyopia
Bottom Line
View on ClinicalTrials.gov: NCT01293240 ↗Enrolled (actual)
117
Serious AEs
0.0%
Results posted
Jun 2012
Primary outcome: Primary: Overall Comfort — 8.6 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- lotrafilcon B contact lens (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CIBA VISION
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Comfort |
8.1 | — |
| PRIMARY Overall Comfort |
8.1 | — |
| PRIMARY End of Day Dryness |
7.0 | — |
| PRIMARY End of Day Dryness |
7.0 | — |
| PRIMARY Ocular Redness |
9.0 | — |
| PRIMARY Ocular Redness |
9.0 | — |
| PRIMARY Visual Clarity |
8.2 | — |
| PRIMARY Visual Clarity |
8.2 | — |
| PRIMARY Lens Deposits |
0.8 | — |
| PRIMARY Lens Deposits |
0.8 | — |
| PRIMARY Corrected Visual Acuity |
0.04 | — |
| PRIMARY Corrected Visual Acuity |
0.04 | — |
Summary
The purpose of this study is to compare the overall performance of a monthly replacement contact lens when worn for one month and when worn for two weeks.
Eligibility Criteria
Inclusion Criteria
- Habitual and successful wearers of contact lenses made of lotrafilcon B material for at least 4 weeks prior to enrollment.
- Good general health.
- Sphere requirement in the range +6.00 to -10.00 with astigmatism or multifocal correction or no astigmatism or multifocal correction.
- Ability to comply with all protocol-mandated procedures and to attend all scheduled office visits.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Anterior segment abnormalities (i.e., cataracts, opacities, etc.) or active anterior segment disease.
- Administration of any investigational drug or device within 14 days of study initiation.
- Use of any eye drops with a pharmacological effect within 7 days of Visit 1.
- Known local or systemic hypersensitivity to contact lens cleaning and disinfecting solutions.
- Post-refractive surgery.
- Currently pregnant or lactating by case history.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01293240). 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.