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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03881670
• Other study ID #: Kollbaum002
• Status: Completed
• Phase: Phase 4
• Start date: December 7, 2018
• Est. completion date: February 8, 2019

Study information

• Verified date: March 2020
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 8, 2019
• Est. primary completion date: February 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperopia
• Myopia

Intervention

Device:
• Lotrafilcon B
commercially available contact lens
• lotrafilcon B with Hydraluxe
commercially available contact lens

Locations

Country	Name	City	State
United States	Indiana University Clinical Optics Research Lab	Bloomington	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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