On-Eye Optical Quality of Lotrafilcon B Lenses Over 12 Hours
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Dec 2018
Shorter than P25 for phase_4
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
Study Start
First participant enrolled
December 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 8, 2019
CompletedFirst Submitted
Initial submission to the registry
February 27, 2019
CompletedFirst Posted
Study publicly available on registry
March 19, 2019
CompletedResults Posted
Study results publicly available
February 24, 2020
CompletedMarch 10, 2020
March 1, 2020
2 months
February 27, 2019
February 3, 2020
March 2, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
0-12 hours
Secondary Outcomes (2)
Subjective Stability of Vision Rating
0-12 hours
Image Quality Metrics
0-12 hours
Study Arms (2)
Lotrafilcon B
PLACEBO COMPARATORLotrafilcon B Hydraluxe
ACTIVE COMPARATORInterventions
commercially available contact lens
Eligibility Criteria
You may qualify if:
- Habitual prescription +5.00 D to -6.00 D
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana Universitylead
- Alcon Researchcollaborator
Study Sites (1)
Indiana University Clinical Optics Research Lab
Bloomington, Indiana, 47405, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pete Kollbaum
- Organization
- IU School of Optometry
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Associate Dean for Research, and Director of the Borish Center for Ophthalmic Research
Study Record Dates
First Submitted
February 27, 2019
First Posted
March 19, 2019
Study Start
December 7, 2018
Primary Completion
February 8, 2019
Study Completion
February 8, 2019
Last Updated
March 10, 2020
Results First Posted
February 24, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share