Toric Contact Lens Digital Performance and Comfort Study

NCT ID: NCT04772560

Last Updated: 2022-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-16
• Study Completion Date: 2021-12-13

Brief Summary

This study seeks to quantify digital visual performance and subjective visual acceptance of toric contact lenses as compared to spherical lenses in low to moderate astigmatic patients.

Detailed Description

This study seeks to quantify the near visual performance and subjective visual acceptance of toric contact lenses as compared to spherical lenses in an astigmatic cohort of patients. Primary Hypotheses: Subjects will have better near visual acuity and near visual performance with toric, as opposed to spherical, contact lens correction. As such, the following hypotheses will be tested: H01: There is no statistically significant difference in near visual acuity or near vision performance between contact lenses corrections Ha1: There is a statistically significant difference in visual acuity or vision performance between contact lenses corrections

Conditions

Astigmatism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Toric, Then Sphere

Participants who received Toric contact lenses first and spherical lenses after 10 days

Group Type: EXPERIMENTAL

Precision1 for Astigmatism

Intervention Type: DEVICE

Daily disposable soft toric contact lens

Precision1 Sphere

Intervention Type: DEVICE

Daily disposable soft spherical contact lens

Sphere, Then Toric

Participants who received Spherical contact lenses first and Toric lenses after 10 days

Group Type: EXPERIMENTAL

Precision1 for Astigmatism

Intervention Type: DEVICE

Daily disposable soft toric contact lens

Precision1 Sphere

Intervention Type: DEVICE

Daily disposable soft spherical contact lens

Interventions

Precision1 for Astigmatism

Daily disposable soft toric contact lens

Intervention Type: DEVICE

Precision1 Sphere

Daily disposable soft spherical contact lens

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 18 to 39 years of age (inclusive)
• pl to -6.00D vertexed sphere power and -0.75 to -1.50D vertexed refractive cylinder OD and OS
• Current/established full time (>6 days week, >8 hours/day) soft contact lens wearer
• Best corrected acuity of 20/25 or better in each eye
• Self-report of at least 4 hrs/day using digital devices
• Willing to wear lenses at least 8 hours each day during the study period
• Able to speak and read English at a high school level / have at least a high school diploma or equivalent (by self-report)

Enclusion Criteria:

• History of ocular pathology or surgery
• Binocular vision disorder (i.e., tropia, convergence or accommodative insufficiency)
• Gas permeable lens wear for at least 3 months
• Symptomatic soft contact lens wearer (CLDEQ-8 score <12 at baseline)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kathryn Richdale

OTHER

Sponsor Role: lead

Responsible Party

Kathryn Richdale

Associate professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kathryn Richdale

Role: PRINCIPAL_INVESTIGATOR

University of Houston College of Optometry

Locations

University of Houston College of Optometry

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

STUDY00002753

Identifier Type: -

Identifier Source: org_study_id