N/A
N=312
A Study to Evaluate the Clinical Performance of a Novel Multipurpose Solution
Ocular Discomfort
Bottom Line
View on ClinicalTrials.gov: NCT01024751 ↗Enrolled (actual)
312
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcome: Primary: Comfort-related Symptoms/Complaints — 89.0; 88.3; 81.7; 81.9 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bausch & Lomb Multi-Purpose Solution (Device); Ciba's Multi-Purpose Solution (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comfort-related Symptoms/Complaints |
89.0; 88.3; 81.7; 81.9; 91.4; 93.1 | — |
| SECONDARY Slit Lamp Findings |
1; 3 | — |
Summary
The objective of this study is to evaluate the clinical performance of Bausch & Lomb investigational Multi-Purpose Solution compared to Ciba Vision Multi-Purpose Solution when used by wearers of silicone hydrogel or Group IV contact lenses.
Eligibility Criteria
Inclusion Criteria
- Participants must be of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed and with the capacity to provide voluntary informed consent.
- Participants must habitually use a lens care product for lens cleaning, disinfecting, and storage.
- Participants must wear a lens in each eye and each lens must be of the same manufacture and brand.
- Participants must agree to wear study lenses on a daily wear basis.
- Participants must be able and willing to comply with all treatment and follow-up/study procedures.
Exclusion Criteria
- Participants participating in any drug or device clinical investigation within 2 weeks prior to entry into this study and/or during the period of study participation.
- Participants with any systemic disease affecting ocular health.
- Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- Participants who have had any corneal surgery (eg, refractive surgery).
- Participants who are allergic to any component in the study care products.
Data sourced from ClinicalTrials.gov (NCT01024751). 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.