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OpenTrials
Completed

NCT Number: NCT03881670

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

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.

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Key information

Conditions

Hyperopia Eye Diseases Myopia Refractive Errors

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Indiana University Clinical Optics Research Lab

Bloomington, Indiana, 47405, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lotrafilcon B

Device

commercially available contact lens

lotrafilcon B with Hydraluxe

Device

commercially available contact lens

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Alcon Research

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 19, 2019
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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