Clinical Evaluation of Two Frequent Replacement Soft Spherical Contact Lenses

NCT05656885 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-142
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This was a single-blind (participant masked), interventional, prospective, direct refit, bilateral wear short-term fitting study.

Conditions

Myopia; Hyperopia

Outcome Measures

Primary Outcomes (1)

• Lens Fit Acceptance Rating

  Measured on lens fit alone on a scale of 0-4 (0=Should not be used; 1=Limit, but unacceptable; 2=Minimum acceptable, early review; 3=Not perfect, but OK to dispense; 4=Perfect) as assessed by an investigator.

  15 minutes

Study Arms (2)

Lens A

EXPERIMENTAL

All participants wore Lens A for 15 minutes (Period 1)

Device: Lens A

Lens B

EXPERIMENTAL

All participants wore Lens B for 15 minutes (Period 2)

Device: Lens B

Interventions

Lens A DEVICE

Soft spherical hydrogel contact lens for 15 minutes

Lens A

Lens B DEVICE

Soft spherical silicone hydrogel contact lens for 15 minutes

Lens B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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 sphere contact lenses, or use spectacles for all distances vision correction, for the past 3 months minimum.
• Has refractive astigmatism no higher than -0.75DC.
• Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (powers +8.00 to -12.00DS)

You may not qualify if:

• 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)

University Complutense of Madrid

Madrid, 28037, Spain

Location

MeSH Terms

Conditions

Myopia; Hyperopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Dr. Jose A Vega OD, MSc, FAAO
• Organization: CooperVision Inc.

javega@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

Model Details: All participants received Lens A and then Lens B in fixed-sequence order.

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 19, 2022
• Study Start: September 27, 2022
• Primary Completion: October 18, 2022
• Study Completion: October 18, 2022
• Last Updated: December 27, 2023
• Results First Posted: December 27, 2023

Record last verified: 2022-12

Locations

ES (1)