Total30 Sphere Contact Lenses

NCT05183022 | Completed Results FDA Device

• 1 other identifier: IRB-300008004
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

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 Sphere CLs.

Conditions

Contact Lens Complication; Dry Eye

Keywords

Total30 Sphere Contact Lenses; Comfort; Dryness; Visual Analog Scale Scores

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS) Ocular Comfort

  A visual analog scale (VAS) was used to compare end of day ocular comfort at 16 hours of contact lens wear over the 1 month study (0 to 100 scale with 100 being best).

  1 month

Study Arms (1)

Total30 Sphere Contact Lenses

EXPERIMENTAL

All qualified participants will be refit into Total30 Sphere contact lenses.

Device: Total30 Sphere Contact Lenses

Interventions

Total30 Sphere Contact Lenses DEVICE

Participants will be refit into Total30 Sphere contact lenses and followed for 1 month.

Also known as: Lehfilcon A

Total30 Sphere Contact Lenses

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Current contact lens wearers who have 20/20 visual acuity or better
• Minimally symptomatic as based upon Contact Lens Dry Eye Questionnaire scores (≤10)
• Astigmatism better than or equal to 0.50 D in each eye
• Must have regularly worn 2 week or monthly contact lenses within the past 6 months
• Must provide a glasses prescription that is is less than 3 years old
• Willing to start wearing their contact lenses between 6:00 AM and 8:00 AM and wear their contact lenses until 11:00 PM each day

You may not qualify if:

• Past or Current hard CL use
• Any known systemic health conditions that are thought to alter tear film physiology
• History of viral eye disease
• History of ocular surgery
• History of severe ocular trauma
• Active ocular infection or inflammation
• Currently using isotretinoin-derivatives
• Currently using ocular medications
• Currently using rewetting drops or artificial tear
• Pregnant or breast feeding

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Alcon Research: collaborator

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35213, United States

Location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Andrew D. Pucker, OD, PhD
• Organization: University of Alabama at Birmingham

apucker@uab.edu

1-920-579-2900

Study Officials

• Andrew D Pucker, OD, MS, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This prospective, one-month, three-visit study will refit all participants into Total30 Sphere contact lenses.

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 10, 2022
• Study Start: January 3, 2022
• Primary Completion: July 20, 2022
• Study Completion: July 20, 2022
• Last Updated: December 16, 2022
• Results First Posted: December 16, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)