The Comparative Clinical Performance of Two Daily Disposable Toric Contact Lenses

Astigmatism Clinical Trial

Official title:

The Comparative Clinical Performance of Two Daily Disposable Toric Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05020990
• Other study ID #: C20-691 (EX-MKTG-121)
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: May 2, 2023

Study information

• Verified date: September 2023
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: May 2, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• Lens A (delefilcon A)
Daily disposable for one week
• Lens B (stenfilcon A)
Daily disposable for one week

Locations

Country	Name	City	State
United Kingdom	Cameron Optometry	Edinburgh	Edinburg
United Kingdom	Phipps Opticians	Heckmondwike
United Kingdom	Simon Falk Eyecare	Oakwood	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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