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

Phase 4

Completed

• Conditions: Myopia; Hyperopia
• Interventions: Device: Lotrafilcon B; Device: lotrafilcon B with Hydraluxe

• Registration Number: NCT03881670
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-12-07
• Primary Completion: 2019-02-08
• Study Completion: 2019-02-08
• Study First Submitted: 2019-02-27
• Study First Submitted QC: 2019-03-18
• Study First Posted: 2019-03-19
• Results First Submitted: 2020-02-03
• Results First Submitted QC: 2020-02-03
• Results First Posted: 2020-02-24
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lotrafilcon B Hydraluxe	Lotrafilcon B	-
Lotrafilcon B	Lotrafilcon B	-
Lotrafilcon B Hydraluxe	lotrafilcon B with Hydraluxe	-
Lotrafilcon B	lotrafilcon B with Hydraluxe	-

Primary Outcome Measures

Name	Time	Method
Higher Order Aberrations	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

Name	Time	Method
Image Quality Metrics	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
Subjective Stability of Vision Rating	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)

Trial Locations

Locations (1)

Indiana University Clinical Optics Research Lab; 🇺🇸 Bloomington, Indiana, United States