The Comparative Clinical Performance of Two Daily Disposable Toric Contact Lenses

NCT05020990 | Completed Results FDA Device

• 1 other identifier: C20-691 (EX-MKTG-121)
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 3

Brief Summary

This study aimed to compare the clinical performance of two daily disposable toric contact lenses.

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (1)

• Subjective Handling Rating on Lens Removal

  Subjective handling rating on lens removal was measured on a scale of 0-100 where 0=Unmanageable and 100=Excellent removal.

  One week

Secondary Outcomes (2)

• Overall Lens Fit at Follow-up

  One Week

• Biomicroscopy Score at Follow-up

  One week

Study Arms (2)

Lens A, then Lens B

EXPERIMENTAL

Participants wore Lens A for one week, then crossed over to wear Lens B for one week.

Device: Lens A (delefilcon A); Device: Lens B (stenfilcon A)

Lens B, then Lens A

EXPERIMENTAL

Participants wore Lens B for one week, then crossed over to wear Lens A for one week.

Device: Lens A (delefilcon A); Device: Lens B (stenfilcon A)

Interventions

Lens A (delefilcon A) DEVICE

Daily disposable for one week

Lens A, then Lens B; Lens B, then Lens A

Lens B (stenfilcon A) DEVICE

Daily disposable for one week

Lens A, then Lens B; Lens B, then Lens 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 at least 18 years old and have the 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 in the past two years.
• They have a spherical component of their contact lens prescription between Plano to - 6.00DS (inclusive).
• They have a cylindrical component of their contact lens prescription between -0.75DC and -2.50DC (inclusive).
• They can be satisfactorily fitted with the study lens types.
• At dispensing, they could attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
• They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
• They own a wearable pair of spectacles.
• They agree not to participate in other clinical research while enrolled on this study.

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 any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
• They have eye or health conditions including immunosuppressive or infectious diseases, 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 are currently wearing one of the study contact lenses.
• They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (3)

Cameron Optometry

Edinburgh, Edinburg, EH3 6SW, United Kingdom

Location

Simon Falk Eyecare

Oakwood, Leeds, LS8 2HU, United Kingdom

Location

Phipps Opticians

Heckmondwike, WF16 0EZ, United Kingdom

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Director Global Clinical Affairs
• Organization: CooperVision Inc.

jvega2@coopervision.com

+19256213761

Study Officials

• Philip Morgan

  Eurolens Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 25, 2021
• Study Start: April 1, 2022
• Primary Completion: September 30, 2022
• Study Completion: May 2, 2023
• Last Updated: December 20, 2023
• Results First Posted: December 20, 2023

Record last verified: 2023-09

Locations

GB (3)