Clinical Evaluation of Hydrogel and Silicone Hydrogel Daily Disposable Toric Contact Lenses

NCT05805085 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-146
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study was to evaluate the patient subjective experiences of two daily disposable toric contact lenses.

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (2)

• Subjective Handling at Insertion, Dispensing Visit

  Subjective handling an lens insertion was assessed at the dispending visit using a 0-100 scale, where 100=Excellent, very easy; 0=Very difficult to manage. Collected once at the end of 15 minutes of wear.

  15 minutes

• Subjecting Handling at Insertion, Follow-up Visit

  Subjective handling at lens insertion was assessed at the follow-up visit using a 0-100 scale, where 100=Excellent, very easy; 0=Very difficult to manage. Collected once at the end of 15 minutes of wear.

  15 minutes

Study Arms (2)

Lens A

EXPERIMENTAL

Participants wore Lens A for 15 minutes (Period 1)

Device: Lens A

Lens B

EXPERIMENTAL

Participants wore Lens B for 15 minutes (Period 2)

Device: Lens B

Interventions

Lens A DEVICE

Hydrogel Daily Disposable Toric Contact Lens for 15 minutes

Lens A

Lens B DEVICE

Silicone Hydrogel Daily Disposable Toric Contact Lens for 15 minutes

Lens B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Is at least 18 years of age and has full legal capacity to volunteer.
• Has read and signed an information consent letter.
• Self-reports having a full eye examination in the previous two years.
• Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week.
• Is willing and able to follow instructions and maintain the appointment schedule.
• Habitual soft contact lens wearers who currently wear toric contact lenses, or use spectacles for all distances vision correction, for the past 3 months minimum.
• Has a contact lens spherical prescription between plano to - 10.00 (inclusive) best corrected visual acuity of 20/30 or better in either eye.
• Has refractive astigmatism no less than -0.75D and no more than 1.75D in both eyes.
• Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
• Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
• Has clear corneas and no active ocular disease.
• Has read, understood, and signed the information consent letter.

You may not qualify if:

• A person was excluded from the study if he/she:
• Is participating in any concurrent clinical or research study.
• Has any known active ocular disease and/or infection that contraindicates contact lens wear.
• Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
• Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.
• Has known sensitivity to the diagnostic sodium fluorescein used in the study.
• Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment.
• Has undergone refractive error surgery or intraocular surgery.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Clinic of Optometry; Faculty of Optics and Optometry

Madrid, 28037, Spain

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: José A. Vega OD, MSc, PhD, FAAO
• Organization: CooperVision Inc.

jvega2@coopervision.com

+19256213761

Study Officials

• Juan G Carracedo Rodríguez, OD, MSc, PhD

  University Complutense of Madrid

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 7, 2023
• Study Start: January 10, 2023
• Primary Completion: November 16, 2023
• Study Completion: November 16, 2023
• Last Updated: December 12, 2024
• Results First Posted: December 12, 2024

Record last verified: 2023-03

Locations

ES (1)