Status:
COMPLETED
Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Corneal Deformity
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief 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
- 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
- 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
Key Trial Info
Start Date :
November 3 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2014
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT02258139
Start Date
November 3 2014
End Date
December 11 2014
Last Update
September 14 2020
Active Locations (1)
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1
Indiana University
Bloomington, Indiana, United States, 47405