Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens

Corneal Deformity Clinical Trial

Official title:

The Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02258139
• Other study ID #: 14-002
• Status: Completed
• Phase: N/A
• Start date: November 3, 2014
• Est. completion date: December 11, 2014

Study information

• Verified date: September 2020
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 11, 2014
• Est. primary completion date: December 11, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Corneal Deformity

Intervention

Device:
• B&L Investigational Contact Lens
The lens used in this study will be supplied by the Sponsor. All subjects will wear a -3.00D lens.

Locations

Country	Name	City	State
United States	Indiana University	Bloomington	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Central Corneal Thickness	Percent change in central corneal thickness from evening to morning (after 8 hours with lid closed)	8 hours
Secondary	Time to Restore Central Corneal Thickness	Time (hours) to restore central corneal thickness to its baseline value after lens removal	48 hours