The Comparative Clinical Performance of Two Daily Disposable Toric Contact Lenses

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

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: Lens A (delefilcon A); Device: Lens B (stenfilcon A)

Detailed Description

This was a multi-center, randomized, participant-masked, bilateral study controlled by cross-comparison. Participants were assigned to either lens type in random sequence. Lenses were worn on a daily disposable wear schedule. Follow-up visits for each lens were performed after 1 week of wear.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Heckmondwike, United Kingdom, WF16 0EZ
    • Phipps Opticians
  • Edinburg
    • Edinburgh, Edinburg, United Kingdom, EH3 6SW
      • Cameron Optometry
  • Leeds
    • Oakwood, Leeds, United Kingdom, LS8 2HU
      • Simon Falk Eyecare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. They are at least 18 years old and have the 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 in the past two years.
5. They have a spherical component of their contact lens prescription between Plano to - 6.00DS (inclusive).
6. They have a cylindrical component of their contact lens prescription between -0.75DC and -2.50DC (inclusive).
7. They can be satisfactorily fitted with the study lens types.
8. 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.
9. They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
10. They own a wearable pair of spectacles.
11. They agree not to participate in other clinical research while enrolled on this study.

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 any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
9. 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.
10. They are currently wearing one of the study contact lenses.
11. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lens A, then Lens B; Participants wore Lens A for one week, then crossed over to wear Lens B for one week.	Device: Lens A (delefilcon A); Daily disposable for one week; Device: Lens B (stenfilcon A); Daily disposable for one week
Experimental: Lens B, then Lens A; Participants wore Lens B for one week, then crossed over to wear Lens A for one week.	Device: Lens A (delefilcon A); Daily disposable for one week; Device: Lens B (stenfilcon A); Daily disposable for one week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Lens Fit at Follow-up	Lens fit was reported as either optimum, acceptable, or unacceptable. To determine this, lens fit parameters (horizontal centration, vertical centration, corneal coverage, and lens movement) were measured on a 5-point scale (-2 to +2), where -2=Extremely nasal, 0=Optimum, and +2=Extremely temporal. Scores between -1 and +1 were considered "Acceptable". For overall lens fit to be 'acceptable', no parameters could be extreme. For a score to be 'optimum', all parameters needed to be optimum.	One Week
Biomicroscopy Score at Follow-up	Slit lamp biomicroscopy was used to assign grades to various biomicroscopic signs, as assessed by investigator, using Efron Grading Scales scored to the nearest 0.1 unit. Grading ranged from 0-4, where 0=None and 4=Severe.	One week

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Philip Morgan, Eurolens Research

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): May 2, 2023

Study Registration Dates

• First Submitted: August 19, 2021
• First Submitted That Met QC Criteria: August 19, 2021
• First Posted (Actual): August 25, 2021

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: C20-691 (EX-MKTG-121)

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