Clinical Evaluation of Two Daily Disposable Lenses in Sphere Design

NCT05516082 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-141
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This was a single-blind, interventional, prospective, direct refit, bilateral wear, fixed-sequence crossover study.

Conditions

Ametropia

Outcome Measures

Primary Outcomes (1)

• Lens Fit Acceptance

  Measured on a scale of 0-4 (0 = Should not be worn, 1 = Borderline but unacceptable, 2 = Min. 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

DDH contact lens for 15 minutes

Lens A

Lens B DEVICE

DDSH contact lens for 15 minutes

Lens B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• 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 the required time of the study.
• Is willing and able to follow instructions and maintain the appointment schedule.
• Has refractive astigmatism no higher than -0.75 DC.
• Can be fit with the available lens parameters (sphere +8.00 to -10.00D).
• Can achieve binocular distance vision of at least 20/30 Snellen (logMAR 0.18) with the study contact lenses.

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)

Dr. Ruben Velazquez Private Practice

Mexico City, 06700, Mexico

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

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

javega@coopervision.com

19256213761

Study Officials

• Rubén V Guerrero, MSc., FIACLE

  Dr. Ruben Velazquez Private Practice

  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: August 23, 2022
• First Posted: August 25, 2022
• Study Start: August 8, 2022
• Primary Completion: October 12, 2022
• Study Completion: October 12, 2022
• Last Updated: November 28, 2023
• Results First Posted: November 28, 2023

Record last verified: 2022-10

Locations

ME (1)