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

Comparative Effectiveness Research Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06230263
• Other study ID #: #IIT89779909
• Status: Recruiting
• Phase: N/A
• Start date: December 30, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: January 2024
• Source: Mopsy Research
• Contact: MANKI CHAN
• Phone: +85225231883
• Email: mank[@]live.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Comparative Effectiveness Research

Intervention

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).

Locations

Country	Name	City	State
Hong Kong	Mopsy Research	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Mopsy Research

Country where clinical trial is conducted

Hong Kong, 

References & Publications (14)

Bhaskaran A, Babu M, Abhilash B, Sudhakar NA, Dixitha V. Comparison of smartphone application-based visual acuity with traditional visual acuity chart for use in tele-ophthalmology. Taiwan J Ophthalmol. 2022 May 13;12(2):155-163. doi: 10.4103/tjo.tjo_7_22. eCollection 2022 Apr-Jun. — View Citation

Buckhurst PJ, Wolffsohn JS, Gupta N, Naroo SA, Davies LN, Shah S. Development of a questionnaire to assess the relative subjective benefits of presbyopia correction. J Cataract Refract Surg. 2012 Jan;38(1):74-9. doi: 10.1016/j.jcrs.2011.07.032. Epub 2011 Nov 10. — View Citation

Calabrese A, To L, He Y, Berkholtz E, Rafian P, Legge GE. Comparing performance on the MNREAD iPad application with the MNREAD acuity chart. J Vis. 2018 Jan 1;18(1):8. doi: 10.1167/18.1.8. — View Citation

Cox SM, Berntsen DA, Bickle KM, Mathew JH, Powell DR, Little BK, Lorenz KO, Nichols JJ. Efficacy of Toric Contact Lenses in Fitting and Patient-Reported Outcomes in Contact Lens Wearers. Eye Contact Lens. 2018 Sep;44 Suppl 1:S296-S299. doi: 10.1097/ICL.0000000000000418. — View Citation

Efron N, Nichols JJ, Woods CA, Morgan PB. Trends in US Contact Lens Prescribing 2002 to 2014. Optom Vis Sci. 2015 Jul;92(7):758-67. doi: 10.1097/OPX.0000000000000623. — View Citation

GRIZZLE JE. THE TWO-PERIOD CHANGE-OVER DESIGN AN ITS USE IN CLINICAL TRIALS. Biometrics. 1965 Jun;21:467-80. No abstract available. — View Citation

Hazari H, Curtis R, Eden K, Hopman WM, Irrcher I, Bona MD. Validation of the visual acuity iPad app Eye Chart Pro compared to the standard Early Treatment Diabetic Retinopathy Study chart in a low-vision population. J Telemed Telecare. 2022 Oct;28(9):680-686. doi: 10.1177/1357633X20960640. Epub 2020 Sep 26. — View Citation

Morgan PB, Efron N, Woods CA; International Contact Lens Prescribing Survey Consortium. An international survey of toric contact lens prescribing. Eye Contact Lens. 2013 Mar;39(2):132-7. doi: 10.1097/ICL.0b013e318268612c. — View Citation

Morgan PB, Efron SE, Efron N, Hill EA. Inefficacy of aspheric soft contact lenses for the correction of low levels of astigmatism. Optom Vis Sci. 2005 Sep;82(9):823-8. doi: 10.1097/01.opx.0000177792.62460.58. — View Citation

Richdale K, Berntsen DA, Mack CJ, Merchea MM, Barr JT. Visual acuity with spherical and toric soft contact lenses in low- to moderate-astigmatic eyes. Optom Vis Sci. 2007 Oct;84(10):969-75. doi: 10.1097/OPX.0b013e318157c6dc. — View Citation

Thompson KA, Soler AP, Smith RM, Jarett L. Intranuclear localization of insulin in rat hepatoma cells: insulin/matrix association. Eur J Cell Biol. 1989 Dec;50(2):442-6. — View Citation

Woods J, Woods CA, Fonn D. Early symptomatic presbyopes--what correction modality works best? Eye Contact Lens. 2009 Sep;35(5):221-6. doi: 10.1097/ICL.0b013e3181b5003b. — View Citation

Young G, Sulley A, Hunt C. Prevalence of astigmatism in relation to soft contact lens fitting. Eye Contact Lens. 2011 Jan;37(1):20-5. doi: 10.1097/ICL.0b013e3182048fb9. — View Citation

Zhang ZT, Zhang SC, Huang XG, Liang LY. A pilot trial of the iPad tablet computer as a portable device for visual acuity testing. J Telemed Telecare. 2013 Jan;19(1):55-9. doi: 10.1177/1357633X12474964. Epub 2013 Feb 22. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Near high-contrast visual acuity (40cm)	Assess near high-contrast visual acuity (40cm) using EyeChart PRO on an iPad.	Day 4, Day 8
Secondary	Reading Acuity	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
Secondary	Critical Print Size	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
Secondary	Maximum Reading Speed	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
Secondary	Reading Accessibility Index	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
Secondary	Near Activity Visual Questionnaire (NAVQ)	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
Secondary	Distance visual acuity	Evaluate distance visual acuity, both high and low contrast, using logMAR and the E-ETDRS (NIDEK SC-2000).	Day 4, Day 8

External Links

•   Howard, J. (2016, July 29). Americans Devote More than 10 Hours a Day to Screen Time, and Growing.