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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
Last Update Posted : June 7, 2019
Sponsor:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
Pete Kollbaum, OD, PhD, Indiana University

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

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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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Higher Order Aberrations [ Time Frame: 0-12 hours ]
    Higher order aberrations will be measured using a pyrimidal aberrometer


Secondary Outcome Measures :
  1. Subjective Quality of Vision Rating [ Time Frame: 0-12 hours ]
    Subjects are asked to rate their quality of vision on a numeric rating scale (0, poor to 100 excellent) (Kollbaum 2012).

  2. Image quality metrics [ Time Frame: 0-12 hours ]
    Root Mean Squared (RMS) wavefront error, Strehl ratio. All image quality metrics will be computed and can be integrated to understand the overall image quality



Information from the National Library of Medicine

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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

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

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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     History of Changes
Other Study ID Numbers: Kollbaum002
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hyperopia
Refractive Errors
Eye Diseases