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To Evaluate the Performance of Total 30 (Lehifilcon A) Contact Lenses in Patients Using Digital Devices for Greater Than 8 Hours Per Day 5 Days Per Week Based on Subjective Reported Data.

T

Tauber Eye Center

Status

Completed

Conditions

Eye Strain

Treatments

Device: Total 30 Contact Lens

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT06317038
89814415

Details and patient eligibility

About

To evaluate the performance of Total 30® (lehfilcon A) contact lenses in patients using digital devices for greater than 8 hours per day 5 days per week based on subjective reported data.

Enrollment

35 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Adult patients aged 18-40 of any sex and any race.
  • Reports habitually using digital device usage (phone, Ipad, computer, social media, video streaming) for 8 hours or more per day 5 days per week with plans to continue the habit throughout the study.
  • Wearing contact lenses for at least 13 hours daily 5 days per week.
  • Spherical refractive error between -11.00 D and +6.00D with < -0.75 D of astigmatism.
  • Willing to comply with the protocol instructions.
  • Has read (or has had read to), understood, and signed an Informed Consent.
  • Willing to not use any artificial tears, rewetting drops or dry eye treatments during the study.

Exclusion criteria

  • Active ocular infection or ocular inflammatory disease.
  • Presbyopic or pre-presbyopic that have a measured add power for reading.
  • Current Total 30 contact lens wearer.
  • Anterior basement membrane dystrophy or history of recurrent erosion syndrome or topographical abnormalities that might indicate ectasia or other corneal degenerative conditions.
  • Current or previous diagnosis of dry eye disease; currently using a dry eye treatment including but not limited to artificial tears, rewetting drops or prescription treatments.
  • History of severe / serious ocular pathology or other medical conditions that could result in an inability to safely complete the study.
  • Participation by the patient in any other investigational study within the past 30 days.
  • Unlikely to comply with protocol instructions for any reason (confusion, substance abuse, etc.). The Principal Investigator or the Medical Monitor reserves the right to declare a patient ineligible based on medical evidence that indicates the patient is unsuitable for the study.
  • Inability to utilize Clear Care Cleaning solution.
  • Pregnancy

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

35 participants in 1 patient group

Digital Device uses for 8 hours per day
Other group
Description:
Observational responses from patients using digital devices for 8 hours per day will be given a monthly Total 30 Contact lens.
Treatment:
Device: Total 30 Contact Lens

Trial contacts and locations

1

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Central trial contact

Crystal D Remington, OD; Ryan Powell, OD

Data sourced from clinicaltrials.gov

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