Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06052046
Other study ID # IRB-00006733
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 15, 2023
Est. completion date June 1, 2024

Study information

Verified date November 2023
Source Southern College of Optometry
Contact Randy Brafford, BS
Phone 901.252.3660
Email rbrafford@sco.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Determine if Total30 for Astigmatism contact lenses (CLs) provide a comfortable wearing experience all day. CL discomfort affects most CL wearers with discomfort consistently topping the reasons why established CL wearers drop out of CLs. In fact, studies have consistently found that the frequency of CL dropout is around 20% with this dropout frequency staying relatively stable over the past 20 plus years. This static frequency of CL dropout is surprising since there have been a number of dramatic soft CL innovations during this time frame (e.g., widely available daily disposable CLs, silicone hydrogel CL materials with high oxygen transmissibility, new CL surface coatings).


Description:

A common issues that contact lens (CL) wearers frequently face is that their discomfort symptoms increase towards the end of the wear day. This burdensome discomfort can unfortunately cause patients to remove their CLs before their desired wear time. While comfortable wear times vary from patient to patient, Terry et al. has suggested that patients should be able to comfortably wear their CLs for at least 12 hours per day for at least 6 days per week. Nevertheless, the literature currently lacks sufficient data to comment fully on the full day wear experience, which for many patients may be 16 or more hours per day, especially if they have demanding careers. One CL that has the potential to allow for all day comfort is the Total30 for Astigmatism CLs, which is a new water gradient, monthly CL aimed at delivering all day comfort and visual performance. Thus, the purpose of this study is to map comfort over the full wear day in established, asymptomatic, soft CL wearers who are refit in Total30 for Astigmatism CLs. These data are not only important for judging the performance of Total30 for Astigmatism CLs, but they will provide some of the first insights into the full day CL wearing experience over one month.


Recruitment information / eligibility

Status Recruiting
Enrollment 48
Est. completion date June 1, 2024
Est. primary completion date May 11, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - 18- to 45-year-old - Visual acuity 20/20 or better - Contact Lens Dry Eye Questionnaire [CLDEQ]-8 scores <10 - Willing to wear Total30 for Astigmatism CLs - Have a smart phone with text messaging capabilities - Astigmatism ranging from 0.75 D to 2.50 D in each eye - Regularly worn 2 week or monthly CLs within the past 6 months - Current CL wearer - Glasses prescription that is less than 2 years old - Willing to start wearing their CLs between 6:00 AM and 8:00 AM and wear their CLs until 11:00 PM each day text messaging data is collected Exclusion Criteria: - Current or past hard CL wearers - A known systemic health condition that is thought to alter tear film physiology - A history of viral eye disease - A history of ocular surgery - A history of severe ocular trauma - Have an active ocular infection or inflammation - Currently using isotretinoin-derivatives or ocular medications - Currently using rewetting drops or artificial tears - Pregnant or breast feeding - Willing to discontinue usage of current toric CLs one week prior to the initial visit

Study Design


Related Conditions & MeSH terms


Intervention

Device:
TOTAL30 for Astigmatism Contact Lenses
Participants will be refit into TOTAL30 for Astigmatism Contact Lenses and followed for 1 month.

Locations

Country Name City State
United States Coldwater VIsion Center Coldwater Mississippi
United States Kannarr Eye Care Pittsburg Kansas

Sponsors (2)

Lead Sponsor Collaborator
Southern College of Optometry Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analog Scale (VAS) Comfort Scores A VAS will be used to compare end of day ocular comfort at about 16 hours of contact lens wear (± 50 scale with +50 being best possible comfort and -50 being worst possible comfort). Change from baseline at 1 month
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04778501 - PMCF Study on Monofocal Toric IOL (PODEYE TORIC) in Asia N/A
Completed NCT04536571 - Vision Stability and Preference for Soft Toric vs. Soft Spherical Contact Lenses N/A
Completed NCT05039112 - Clinical Comparison of 2 Daily Disposable Toric Soft Contact Lenses N/A
Completed NCT04613882 - Quantification of the Visual Benefits of Soft Toric Contact Lenses Compared to Soft Spherical Contact Lenses N/A
Recruiting NCT05611294 - Contralateral Study of Topography Guided LASIK Versus Small Incision Lenticule Extraction N/A
Completed NCT05633082 - A Clinical Performance of Two Soft Toric Contact Lenses N/A
Not yet recruiting NCT05506553 - Comparison of Aspheric Toric Intraocular Lenses for Micro-monovision N/A
Not yet recruiting NCT05561296 - Astigmatism Management With Iris-registration Guided Corneal Relaxing Incisions or Toric IOLs During Cataract Surgery N/A
Completed NCT02847169 - Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear N/A
Recruiting NCT02618018 - Clinical Evaluation of Efficacy and Stability of AT TORBI 709M 4-haptic Toric IOL in Cataract Surgery N/A
Completed NCT02423109 - Bilateral Dispensing Study of Fanfilcon A Toric Versus Enfilcon A Toric Lenses N/A
Completed NCT02550353 - Changes Between Lenticule Extraction and Femtosecond Laser-assisted Laser in Situ Keratomileusis N/A
Completed NCT02555098 - A Bilateral Dispensing Clinical Trial of an Sapphire Lens Against Senofilcon A Toric for Astigmatism Lens N/A
Completed NCT02551796 - Early Changes Among FLEx, LASIK and FS-LASIK N/A
Completed NCT02248766 - Clinical Performance of Habitual Wearers of Avaira Toric When Refitted With Clariti Toric Lenses N/A
Completed NCT01857102 - Toric Eye Strain and Stability Study N/A
Completed NCT01965288 - Clinical Performance of Biofinity Toric Versus Air Optix for Astigmatism N/A
Withdrawn NCT01680354 - Surgical Correction of Astigmatism N/A
Completed NCT02624791 - Evaluating and Improving Functional Driving Vision of Patients With Astigmatism N/A
Completed NCT01207466 - Evaluation of Two Daily Disposable Contact Lenses for Wearers With Astigmatism N/A