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

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

Study Overview

• Status: Completed
• Conditions: Myopia; Hyperopia
• Intervention / Treatment: Device: Lens 1 (ocufilcon D); Device: Lens 2 (somofilcon A)

Detailed Description

The aim of this study is to evaluate the short-term clinical performance of two soft contact lenses when compared to each other after 15 minutes of daily wear each.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom
    • Eurolens Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. They have an ocular disorder which would normally contra-indicate contact lens wear.
2. They have a systemic disorder which would normally contra-indicate contact lens wear.
3. They are using any topical medication such as eye drops or ointment.
4. They are aphakic.
5. They have had corneal refractive surgery.
6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
7. They are pregnant or breastfeeding.
8. 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.
9. They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lens 1 (ocufilcon D); All participants will wear lens 1 for 15 minutes (Period 1).	Device: Lens 1 (ocufilcon D); 15 minutes of daily wear
Experimental: Lens 2 (somofilcon A); All participants will wear lens 2 for 15 minutes (Period 2).	Device: Lens 2 (somofilcon A); 15 minutes of daily wear

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Vision	The secondary outcome measure for this study is the subjective vision on a scale of 0-100 (0= Extremely poor, intolerable, lenses cannot be worn, 100= Excellent, unaware of any visual loss).	At the end of 15 minutes of daily wear
Subjective Comfort	The secondary outcome measure for this study is the subjective comfort on a scale of 0-100 (0= Extremely uncomfortable, causes pain, cannot be tolerated, 100= Excellent, cannot be felt).	At the end of 15 minutes of daily wear

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Carole Maldonado-Codina, PhD, FBCLA, Eurolens Research

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2024
• Primary Completion (Actual): January 31, 2025
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: December 26, 2024
• First Submitted That Met QC Criteria: December 26, 2024
• First Posted (Actual): January 3, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Hyperopia
• Other Study ID Numbers: EX-MKTG-162

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes