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On-Eye Optical Quality of Lotrafilcon B Lenses Over 12 Hours

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ClinicalTrials.gov Identifier: NCT03881670
Recruitment Status : Completed
First Posted : March 19, 2019
Results First Posted : February 24, 2020
Last Update Posted : March 10, 2020
Sponsor:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
Pete Kollbaum, OD, PhD, Indiana University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hyperopia Myopia Device: Lotrafilcon B Device: lotrafilcon B with Hydraluxe Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: On-Eye Optical Quality of Lotrafilcon B Lenses Over 12 Hours
Actual Study Start Date : December 7, 2018
Actual Primary Completion Date : February 8, 2019
Actual Study Completion Date : February 8, 2019

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Lotrafilcon B Device: Lotrafilcon B
commercially available contact lens

Device: lotrafilcon B with Hydraluxe
commercially available contact lens
Active Comparator: Lotrafilcon B Hydraluxe Device: Lotrafilcon B
commercially available contact lens

Device: lotrafilcon B with Hydraluxe
commercially available contact lens


Outcome Measures
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Primary Outcome Measures :
  1. Higher Order Aberrations [ Time Frame: 0-12 hours ]
    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 :
  1. Subjective Stability of Vision Rating [ Time Frame: 0-12 hours ]
    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)

  2. Image Quality Metrics [ Time Frame: 0-12 hours ]
    Root Mean Squared (RMS) wavefront error over a 3mm pupil; difference in RMS error between 0 and 12 hour timepoints; averaged across all subjects


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881670


Locations
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United States, Indiana
Indiana University Clinical Optics Research Lab
Bloomington, Indiana, United States, 47405
Sponsors and Collaborators
Indiana University
Alcon Research
  Study Documents (Full-Text)

Documents provided by Pete Kollbaum, OD, PhD, Indiana University:
Study Protocol and Statistical Analysis Plan  [PDF] September 5, 2018

More Information
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Responsible Party: Pete Kollbaum, OD, PhD, Associate Professor, Associate Dean for Research, and Director of the Borish Center for Ophthalmic Research, Indiana University
ClinicalTrials.gov Identifier: NCT03881670    
Other Study ID Numbers: Kollbaum002
First Posted: March 19, 2019    Key Record Dates
Results First Posted: February 24, 2020
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Hyperopia
Refractive Errors
Eye Diseases