N/A
N=38
Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens
Corneal Deformity
Bottom Line
View on ClinicalTrials.gov: NCT02258139 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Percent Change in Central Corneal Thickness — 4.01; 5.57 milimeters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- B&L Investigational Contact Lens (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Central Corneal Thickness |
4.01; 5.57 | — |
| SECONDARY Time to Restore Central Corneal Thickness |
0; 5.3; 34.2; 63.2; 44.7; 23.7 | — |
Summary
This will be a randomized non-dispensing study comparing the overnight corneal swelling of an eye while wearing no contact lens to the Ultra contract lens.
Eligibility Criteria
Inclusion Criteria
- Be between 18 and 40 years of age (inclusive)
- Not a current contact lens wearer (have not worn extended wear, and not worn in lenses in 6 months)
- Able to read, comprehend and sign an informed consent
- Willing to comply with the wear and study visit schedule
- Monocular best-corrected distance visual acuity >/-20/25 in each eye
Exclusion Criteria
- Any active corneal infection, disease, injury, inflammation, past surgery, or ocular abnormality which may interfere with contact lens wear
- Systemic or ocular allergies, which might interfere with contact lens wear
- Systemic disease or condition, which might interfere with contact lens wear
- Use of prescription sleep aids or alcohol within 24 hours of study appointment
- Inability to wear contact lenses
- Under 18 years of age
Data sourced from ClinicalTrials.gov (NCT02258139). 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.