Clinical trial NCT06230263: Comparative Functional Vision Outcomes: DAILIES TOTAL1 Toric vs. Spherical Lenses in Asian Astigmatic Patients
Official title: A Comparative Study on Functional Vision in Astigmatic Patients: DAILIES TOTAL1 Toric Contact Lenses vs. Spherical Equivalent Contact Lenses in Asian Eyes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Comparative Effectiveness Research
Keywords: Astigmatism
Toric Contact Lenses
Contact Lens Satisfaction
Digital Device Usage
Lead sponsor: Mopsy Research
Sponsor class: NETWORK
First posted: 2024-01-30
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study will follow a double-masked randomized crossover design \[10\], where participants will be fitted with DAILIES TOTAL1® for Astigmatism and DAILIES TOTAL1® Spherical Contact Lenses in a randomized order. Each participant will use both types of lenses over different periods.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Near high-contrast visual acuity (40cm)
timeFrame: Day 4, Day 8
Secondary outcomes:
measure: Reading Acuity
timeFrame: Day 4, Day 8
measure: Critical Print Size
timeFrame: Day 4, Day 8
measure: Maximum Reading Speed
timeFrame: Day 4, Day 8
measure: Reading Accessibility Index
timeFrame: Day 4, Day 8
measure: Near Activity Visual Questionnaire (NAVQ)
timeFrame: Day 4, Day 8
measure: Distance visual acuity
timeFrame: Day 4, Day 8
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Mopsy Research
Study officials:
affiliation: Mopsy Research
name: MANKI CHAN
role: PRINCIPAL_INVESTIGATOR
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