N/A
N=20
Ocular Comfort and OCT Observation of Post Lens Clearance and Ocular Tissue Compression
Ocular Comfort
Bottom Line
View on ClinicalTrials.gov: NCT01423773 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2012
Primary outcome: Primary: Final Comfort — 87.6; 87.9 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lotrafilcon A test contact lens (Device); Lotrafilcon A control contact lens (Device); Ultra-High Resolution Optical Coherence Tomographer (OCT) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CIBA VISION
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Final Comfort |
87.6; 87.9 | — |
Summary
The purpose of this study was to compare the fit and comfort of two types of contact lenses.
Eligibility Criteria
Inclusion Criteria
- Be of legal age of consent and sign Informed Consent document.
- Normal binocularity.
- Be able to wear soft contact lenses.
- Willing to comply with the wear and study visit schedule.
- Spherical contact lens prescription within 0.50 diopter of the available lens powers.
- Spectacle cylinder less than or equal to 1.50 diopter.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Eye injury or surgery within twelve weeks of enrollment.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Currently enrolled in any clinical trial.
- Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions as determined by the investigator.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01423773). 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.