The Comparative Clinical Performance of Two Daily Disposable Toric Contact Lenses

Not Applicable

Completed

• Conditions: Astigmatism
• Interventions: Device: Lens A (delefilcon A); Device: Lens B (stenfilcon A)

• Registration Number: NCT05020990
• Lead Sponsor: Coopervision, Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-08-19
• Study First Submitted QC: 2021-08-19
• Study First Posted: 2021-08-25
• Study Start: 2022-04-01
• Primary Completion: 2022-09-30
• Study Completion: 2023-05-02
• Status Verified: 2023-09
• Results First Submitted: 2023-11-28
• Results First Submitted QC: 2023-11-28
• Last Update Submitted: 2023-11-28
• Results First Posted: 2023-12-20
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lens A, then Lens B	Lens B (stenfilcon A)	Participants wore Lens A for one week, then crossed over to wear Lens B for one week.
Lens A, then Lens B	Lens A (delefilcon A)	Participants wore Lens A for one week, then crossed over to wear Lens B for one week.
Lens B, then Lens A	Lens B (stenfilcon A)	Participants wore Lens B for one week, then crossed over to wear Lens A for one week.
Lens B, then Lens A	Lens A (delefilcon A)	Participants wore Lens B for one week, then crossed over to wear Lens A for one week.

Primary Outcome Measures

Name	Time	Method
Subjective Handling Rating on Lens Removal	One week	Subjective handling rating on lens removal was measured on a scale of 0-100 where 0=Unmanageable and 100=Excellent removal.

Secondary Outcome Measures

Name	Time	Method
Overall Lens Fit at Follow-up	One Week	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.
Biomicroscopy Score at Follow-up	One week	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.

Trial Locations

Locations (3)

Simon Falk Eyecare; 🇬🇧 Oakwood, Leeds, United Kingdom

Cameron Optometry; 🇬🇧 Edinburgh, Edinburg, United Kingdom

Phipps Opticians; 🇬🇧 Heckmondwike, United Kingdom