Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens
The Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens
1 other identifier
interventional
38
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2014
CompletedFirst Posted
Study publicly available on registry
October 7, 2014
CompletedStudy Start
First participant enrolled
November 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 11, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 11, 2014
CompletedResults Posted
Study results publicly available
September 14, 2020
CompletedSeptember 14, 2020
September 1, 2020
1 month
October 3, 2014
August 21, 2020
September 11, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Time to Restore Central Corneal Thickness
48 hours
Study Arms (1)
Study Group 1
EXPERIMENTAL1st overnight visit with no contact lens; 2nd overnight visit randomized to either left or right eye for B\&L Investigational Contact Lens
Interventions
The lens used in this study will be supplied by the Sponsor. All subjects will wear a -3.00D lens.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Indiana University
Bloomington, Indiana, 47405, United States
Results Point of Contact
- Title
- Study Director
- Organization
- Bausch Health
Study Officials
- STUDY DIRECTOR
Robert Steffen, OD, MS
Bausch & Lomb Incorporated
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2014
First Posted
October 7, 2014
Study Start
November 3, 2014
Primary Completion
December 11, 2014
Study Completion
December 11, 2014
Last Updated
September 14, 2020
Results First Posted
September 14, 2020
Record last verified: 2020-09