Back to resultsOn-Eye Optical Quality of Lotrafilcon B Lenses Over 12 Hours
Primary Purpose
Hyperopia, Myopia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lotrafilcon B
lotrafilcon B with Hydraluxe
Sponsored by
About this trial
This is an interventional treatment trial for Hyperopia
Eligibility Criteria
Inclusion Criteria:
- Habitual prescription +5.00 D to -6.00 D
- 18-35 years of age
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Vertex corrected refractive cylinder must be -0.75 or less.
- Visual acuity best correctable to 20/25 or better for each eye
- The subject must read and sign the Informed Consent form.
- Mesopic pupil size >5.00 mm.
Exclusion Criteria:
- active condition that would prevent contact lens wear
- history of issues of eye alignment or binocularity by self-report
- doctor diagnosed, self-reported accommodative or binocular vision issues
- doctor diagnosed, self-reported ocular surface disease or dry eye requiring regular, ongoing treatment
Sites / Locations
- Indiana University Clinical Optics Research Lab
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Lotrafilcon B
Lotrafilcon B Hydraluxe
Arm Description
Outcomes
Primary Outcome Measures
Higher Order Aberrations
Higher-order Root Mean Squared (RMS) over a 3mm pupil; difference in RMS error between 0 and 12 hour timepoints; averaged across all subjects
Secondary Outcome Measures
Subjective Stability of Vision Rating
Subjects are asked to rate their stability of vision on a numeric rating scale (0, poor to 100 excellent) (Kollbaum 2012). The difference between time 0 and time 12 hours is reported for all subjects (negative number represents a decrease in stability of vision)
Image Quality Metrics
Root Mean Squared (RMS) wavefront error over a 3mm pupil; difference in RMS error between 0 and 12 hour timepoints; averaged across all subjects
Full Information
NCT ID
NCT03881670
First Posted
February 27, 2019
Last Updated
March 2, 2020
Sponsor
Indiana University
Collaborators
Alcon Research
1. Study Identification
Unique Protocol Identification Number
NCT03881670
Brief Title
On-Eye Optical Quality of Lotrafilcon B Lenses Over 12 Hours
Official Title
On-Eye Optical Quality of Lotrafilcon B Lenses Over 12 Hours
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 7, 2018 (Actual)
Primary Completion Date
February 8, 2019 (Actual)
Study Completion Date
February 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Alcon Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The current study aims to systematically investigate the diurnal variation in the optical quality of soft contact lenses on eye throughout the day. Subject reported quality of vision will also be evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperopia, Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lotrafilcon B
Arm Type
Placebo Comparator
Arm Title
Lotrafilcon B Hydraluxe
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Lotrafilcon B
Intervention Description
commercially available contact lens
Intervention Type
Device
Intervention Name(s)
lotrafilcon B with Hydraluxe
Intervention Description
commercially available contact lens
Primary Outcome Measure Information:
Title
Higher Order Aberrations
Description
Higher-order Root Mean Squared (RMS) over a 3mm pupil; difference in RMS error between 0 and 12 hour timepoints; averaged across all subjects
Time Frame
0-12 hours
Secondary Outcome Measure Information:
Title
Subjective Stability of Vision Rating
Description
Subjects are asked to rate their stability of vision on a numeric rating scale (0, poor to 100 excellent) (Kollbaum 2012). The difference between time 0 and time 12 hours is reported for all subjects (negative number represents a decrease in stability of vision)
Time Frame
0-12 hours
Title
Image Quality Metrics
Description
Root Mean Squared (RMS) wavefront error over a 3mm pupil; difference in RMS error between 0 and 12 hour timepoints; averaged across all subjects
Time Frame
0-12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Habitual prescription +5.00 D to -6.00 D
18-35 years of age
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Vertex corrected refractive cylinder must be -0.75 or less.
Visual acuity best correctable to 20/25 or better for each eye
The subject must read and sign the Informed Consent form.
Mesopic pupil size >5.00 mm.
Exclusion Criteria:
active condition that would prevent contact lens wear
history of issues of eye alignment or binocularity by self-report
doctor diagnosed, self-reported accommodative or binocular vision issues
doctor diagnosed, self-reported ocular surface disease or dry eye requiring regular, ongoing treatment
Facility Information:
Facility Name
Indiana University Clinical Optics Research Lab
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
On-Eye Optical Quality of Lotrafilcon B Lenses Over 12 Hours
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