A Clinical Comparison of Two Soft Contact Lenses (C24-755)

NCT06758076 | Completed FDA Device

• 1 other identifier: EX-MKTG-162
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the short-term clinical performance of two soft contact lenses.

Conditions

Hyperopia; Myopia

Outcome Measures

Primary Outcomes (1)

• Subjective Overall Score

  The primary outcome measure for this study is the subjective overall score on a scale of 0-100 (0= Extremely poor, unmanageable, cannot use lenses, 100= Excellent, highly impressed with these lenses overall).

  At the end of 15 minutes of daily wear

Secondary Outcomes (2)

• Subjective Vision

  At the end of 15 minutes of daily wear

• Subjective Comfort

  At the end of 15 minutes of daily wear

Study Arms (2)

Lens 1 (ocufilcon D)

EXPERIMENTAL

All participants will wear lens 1 for 15 minutes (Period 1).

Device: Lens 1 (ocufilcon D)

Lens 2 (somofilcon A)

EXPERIMENTAL

All participants will wear lens 2 for 15 minutes (Period 2).

Device: Lens 2 (somofilcon A)

Interventions

Lens 1 (ocufilcon D) DEVICE

15 minutes of daily wear

Lens 1 (ocufilcon D)

Lens 2 (somofilcon A) DEVICE

15 minutes of daily wear

Lens 2 (somofilcon A)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• They are of legal age (18) and capacity to volunteer.
• They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
• They are willing and able to follow the protocol.
• They currently wear soft contact lenses, or have done so within the past two years.
• They are expected to be able to be fitted with the study lenses within the power range available.

You may not qualify if:

• They have an ocular disorder which would normally contra-indicate contact lens wear.
• They have a systemic disorder which would normally contra-indicate contact lens wear.
• They are using any topical medication such as eye drops or ointment.
• They are aphakic.
• They have had corneal refractive surgery.
• They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
• They are pregnant or breastfeeding.
• They have an eye or health condition including an immunosuppressive or infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.
• They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Eurolens Research

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Hyperopia; Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Carole Maldonado-Codina, PhD, FBCLA

  Eurolens Research

  PRINCIPAL INVESTIGATOR

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: December 26, 2024
• First Posted: January 3, 2025
• Study Start: November 18, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: April 13, 2026

Record last verified: 2024-09

Locations

GB (1)