Comparative Functional Vision Outcomes: DAILIES TOTAL1 Toric vs. Spherical Lenses in Asian Astigmatic Patients

January 19, 2024 updated by: Mopsy Research

A Comparative Study on Functional Vision in Astigmatic Patients: DAILIES TOTAL1 Toric Contact Lenses vs. Spherical Equivalent Contact Lenses in Asian Eyes

The goal of this comparative clinical trial is to assess the effectiveness of DAILIES TOTAL1 Toric Contact Lenses compared to Spherical Equivalent Contact Lenses in improving the functional vision of astigmatic patients, with a particular focus on Asian individuals who frequently use digital devices.

The main questions it aims to answer are:

How do DAILIES TOTAL1 Toric Contact Lenses affect the quality of vision in daily activities, especially when using digital screens, compared to Spherical Equivalent Contact Lenses?

What is the level of comfort and overall satisfaction among participants using DAILIES TOTAL1 Toric Contact Lenses versus those using Spherical Equivalent Contact Lenses?

Participants will be asked to wear both types of contact lenses for a specified period. During this time, they will perform various tasks involving digital screens. Their vision quality and comfort levels will be monitored and recorded. They will also be asked to report their satisfaction with each type of lens and any differences in their experience with screen use.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background:

In today's digital age, individuals spend a significant amount of time using digital devices [1]. This is notably challenging for individuals with astigmatism, a condition that can impair visual acuity when using these devices [2]. Despite the prevalence of astigmatism, toric contact lens technology, which can potentially improve visual acuity for these individuals, remains underused [3][4]. Many eye care practitioners opt for spherical lenses due to perceived complexities of fitting and considerations of cost-effectiveness [5][6].

DAILIES TOTAL1® for Astigmatism contact lenses, the first and only daily disposable Water Gradient toric contact lenses, can potentially address this issue. These lenses represent a significant innovation in toric contact lens technology, offering a unique combination of breathability and exceptional comfort. The lenses utilize Water Gradient Technology, creating a gradual transition in water content from the core to the surface of the lens, with the water content approaching 100% at the lens surface. This technology enables these lenses to offer a combination of high breathability and exceptional comfort.

Unmet Medical Need:

Although toric lenses, including DAILIES TOTAL1® for Astigmatism, have been shown to improve visual acuity in astigmatic patients, their impact on real-world visual performance, particularly when using digital devices, is less understood [1]. Additionally, while many practitioners gravitate towards spherical lenses, astigmatic patients could greatly benefit from the comfort and visual acuity provided by DAILIES TOTAL1® for Astigmatism contact lenses.

Gaining insights into the real-world visual performance of astigmatic patients when using DAILIES TOTAL1® for Astigmatism contact lenses could provide valuable information to eye care practitioners and patients. This could potentially encourage the broader adoption of DAILIES TOTAL1® for Astigmatism contact lenses, improving the visual experience for astigmatic patients and addressing an unmet medical need.

Scientific Rationale:

Previous clinical studies have demonstrated the benefits of toric contact lenses in improving visual acuity in astigmatic patients[5]. However, these studies primarily used traditional high-contrast, high-luminance visual acuity testing, which may not accurately reflect the visual demands of real-world tasks, especially those involving digital devices [7][8].

DAILIES TOTAL1® for Astigmatism contact lenses stand out due to their unique Water Gradient Technology and Precision Balance 8|4® Lens Design. The gradual transition in water content from the core to the surface of the lens, with the water content approaching 100% at the lens surface, enables a combination of high breathability and exceptional comfort. The lens design ensures a quick and stable fit, with 99% first-lens fit success. Additionally, these lenses feature SmarTears® Technology, which releases an ingredient found naturally in tears to stabilize the lipid layer of the tear film, further promoting comfort for the wearer.

This study seeks to extend previous findings by evaluating the impact of DAILIES TOTAL1® for Astigmatism Contact Lenses on subjective and objective visual performance outcomes in astigmatic patients using digital devices [9]. This will involve the use of advanced digital real-world and patient-reported outcome tools, providing a comprehensive evaluation of vision beyond acuity alone. The goal is to ascertain whether the unique benefits of DAILIES TOTAL1® for Astigmatism Contact Lenses translate to improved functional vision and overall satisfaction for astigmatic patients.

Objective:

This study aims to assess the impact of DAILIES TOTAL1® for Astigmatism Contact Lenses on the functional vision of astigmatic patients as compared to DAILIES TOTAL1® Spherical Contact Lenses, using digital real-world and patient-reported outcome tools in Asian Eyes.

Hypothesis:

DAILIES TOTAL1® for Astigmatism Contact Lenses will improve both subjective and objective visual performance in astigmatic patients using digital devices compared to DAILIES TOTAL1® Spherical Contact Lenses in Asian Eyes.

Study Type

Interventional

Enrollment (Estimated)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: MANKI CHAN
  • Phone Number: +85225231883
  • Email: mank@live.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 0000
        • Recruiting
        • Mopsy Research
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Self-identified as Asian, confirmed through both self-report and observation by the Principal Investigator (PI).
  • Age between 18 and 39 years.
  • Vertexed corrected sphere power ranging from -0.50 to -6.00 diopters (D).
  • Vertexed refractive cylinder power ranging from -0.75 to -1.50 diopters (D).
  • Best corrected visual acuity of 20/25 or better in each eye.
  • Habitual soft contact lens wear for at least 6 months and must be successfully fitted with both DT1 Spherical and Toric contact lenses.

Exclusion Criteria:

  • Any history of ocular pathology or surgery.
  • Presence of active ocular infection or clinically significant ocular inflammation.
  • Presence of any significant binocular vision abnormalities.
  • Use of gas-permeable contact lenses within 3 months prior to the study.
  • Pregnancy or lactation, confirmed by self-report.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DAILIES TOTAL1® for Astigmatism
Diagnostic test: Visual acuity test

Assess near high-contrast visual acuity (40cm) using EyeChart PRO on an iPad.

Use the MNREAD app to measure:

Reading Acuity: Smallest font size read without errors. Critical Print Size: Smallest font size for peak reading speed. Maximum Reading Speed: Time to read comfortable font size, in words per minute. Reading Accessibility Index: Single metric summarizing visual access to print. Assess near visual function with the Near Activity Visual Questionnaire.

Evaluate distance visual acuity, both high and low contrast, using logMAR and the E-ETDRS (NIDEK SC-2000).

Other Names:
  • Reading acuity test
  • Near Activity Visual Questionnaire
Active Comparator: Spherical Contact Lenses
DAILIES TOTAL1® Spherical Contact Lenses
Diagnostic test: Visual acuity test

Assess near high-contrast visual acuity (40cm) using EyeChart PRO on an iPad.

Use the MNREAD app to measure:

Reading Acuity: Smallest font size read without errors. Critical Print Size: Smallest font size for peak reading speed. Maximum Reading Speed: Time to read comfortable font size, in words per minute. Reading Accessibility Index: Single metric summarizing visual access to print. Assess near visual function with the Near Activity Visual Questionnaire.

Evaluate distance visual acuity, both high and low contrast, using logMAR and the E-ETDRS (NIDEK SC-2000).

Other Names:
  • Reading acuity test
  • Near Activity Visual Questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Near high-contrast visual acuity (40cm)
Time Frame: Day 4, Day 8
Assess near high-contrast visual acuity (40cm) using EyeChart PRO on an iPad.
Day 4, Day 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reading Acuity
Time Frame: Day 4, Day 8

Reading Acuity refers to the smallest font size at which text can be read without errors.

The MNREAD app will be used to determine the Reading Acuity, which will be reported in units of point size (pt).
Day 4, Day 8
Critical Print Size
Time Frame: Day 4, Day 8

Critical Print Size is the smallest font size at which the individual achieves their peak reading speed.

The MNREAD app will measure the Critical Print Size and report it in point size (pt).
Day 4, Day 8
Maximum Reading Speed
Time Frame: Day 4, Day 8

Maximum Reading Speed is the fastest rate at which text in a comfortable font size can be read.

The MNREAD app will record the Maximum Reading Speed in words per minute (wpm).
Day 4, Day 8
Reading Accessibility Index
Time Frame: Day 4, Day 8

Reading Accessibility Index is a single metric that summarizes an individual's visual access to print.

The MNREAD app will calculate the Reading Accessibility Index based on a combination of the above measures. The index will be dimensionless but will take into account the variations in font size (pt) and reading speed (wpm) to provide a standardized score reflecting overall reading accessibility.
Day 4, Day 8
Near Activity Visual Questionnaire (NAVQ)
Time Frame: Day 4, Day 8

The Near Activity Visual Questionnaire (NAVQ) is used to assess the near visual function, which includes the ability to perform activities that require close-up vision.

Participants will respond to the NAVQ, which will be scored on a scale ranging from 0 to 3 for each item.

  • **Scale Range**: The scale ranges from 0 to 3, where:
  • '0' indicates no difficulty,
  • '1' indicates mild difficulty,
  • '2' indicates moderate difficulty,
  • '3' indicates extreme difficulty.

The total NAVQ score is calculated by summing the individual scores for each item. The minimum score is '0', which would indicate no difficulty with near visual tasks, and the maximum possible score is dependent on the number of items in the questionnaire.

Lower Scores Represent**: A better outcome, with less difficulty in near visual tasks.

Higher Scores Represent**: A worse outcome, with greater difficulty in near visual tasks.
Day 4, Day 8
Distance visual acuity
Time Frame: Day 4, Day 8
Evaluate distance visual acuity, both high and low contrast, using logMAR and the E-ETDRS (NIDEK SC-2000).
Day 4, Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mopsy Research

Investigators

  • Principal Investigator: MANKI CHAN, Mopsy Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

January 11, 2024

First Submitted That Met QC Criteria

January 19, 2024

First Posted (Actual)

January 30, 2024

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 19, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • #IIT89779909

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

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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