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.

Study Overview

• Status: Completed
• Conditions: Myopia; Hyperopia
• Intervention / Treatment: Device: Lotrafilcon B; Device: lotrafilcon B with Hydraluxe

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • Indiana University Clinical Optics Research Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	0-12 hours
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	0-12 hours

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Alcon Research

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 7, 2018
• Primary Completion (ACTUAL): February 8, 2019
• Study Completion (ACTUAL): February 8, 2019

Study Registration Dates

• First Submitted: February 27, 2019
• First Submitted That Met QC Criteria: March 18, 2019
• First Posted (ACTUAL): March 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 2, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Hyperopia
• Other Study ID Numbers: Kollbaum002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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