A Clinical Comparison of Two Soft Contact Lenses

NCT05741450 | Completed Results FDA Device

• 1 other identifier: C22-724 (EX-MKTG-138)
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The study objective was to gather short-term clinical performance data for two soft contact lenses.

Conditions

Myopia; Hyperopia

Outcome Measures

Primary Outcomes (1)

• Subjective Overall Score

  Subjective overall score was assessed using 0-100 visual analogue scale, where 0=Extremely poor, cannot use lenses and 100=Excellent, highly impressed with these lenses overall

  15 minutes

Secondary Outcomes (2)

• Subjective Comfort

  15 minutes

• Subjective Vision

  15 minutes

Study Arms (2)

Lens 1

EXPERIMENTAL

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

Device: Lens 1 (monthly replacement)

Lens 2

EXPERIMENTAL

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

Device: Lens 2 (daily disposable)

Interventions

Lens 1 (monthly replacement) DEVICE

Monthly replacement spherical silicone hydrogel contact lens for 15 minutes

Lens 1

Lens 2 (daily disposable) DEVICE

Daily disposable spherical silicone hydrogel contact lens for 15 minutes

Lens 2

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 lactating.
• 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

Myopia; Hyperopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

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

jvega2@coopervision.com

+19256213761

Study Officials

• Philip Morgan, PhD, MCOptom

  Eurolens Research

  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 1 and then Lens 2 in fixed-sequence order.

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 23, 2023
• Study Start: November 24, 2022
• Primary Completion: December 5, 2022
• Study Completion: December 5, 2022
• Last Updated: January 10, 2024
• Results First Posted: January 10, 2024

Record last verified: 2023-02

Locations

GB (1)