Clinical Evaluation of Proclear Toric and Biofinity Toric

Astigmatism Clinical Trial

Official title:

Clinical Evaluation of Proclear Toric and Biofinity Toric

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06431061
• Other study ID #: EX-MKTG-158
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 20, 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: May 2024
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the short-term clinical performance of two Toric contact lenses.

Description:

The aim of the study is to evaluate and compare the performance of two soft toric contact lenses in existing soft toric lens wearers in a short term (15 minutes wear) study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

1. Are at least 17 years of age and has full legal capacity to volunteer.

2. Have understood and signed an information consent letter.

3. Are willing and able to follow instructions and maintain the appointment schedule.

4. Are an adapted soft toric contact lens wearer.

5. Do not habitually wear either of the two study lens types.

6. Have a vertex-corrected contact lens prescription with a spherical component of +4.00D to -9.00D in combination with astigmatism of no less than -0.75D and no more than -2.25D in each eye.

7. Can achieve best corrected distance visual acuity of +0.10 logMAR (subjective refraction) or better in each eye.

8. Can be fitted with and achieve a distance visual acuity of +0.18 logMAR or better in each eye with the study contact lenses.

Exclusion Criteria:

1. Are participating in any concurrent clinical or research study.

2. Have any known active ocular disease and/or infection or slit lamp findings that would contraindicate contact lens use.

3. Have a systemic condition that in the opinion of the investigator may affect a study outcome variable.

4. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable.

5. Have known sensitivity to the diagnostic pharmaceuticals to be used in the study.

6. Have a history of not achieving comfortable CL use (5 days per week; > 8 hours/day)

7. Are an employee of the Centre for Ocular Research & Education directly involved in the study (i.e. on the delegation log).

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• Lens A (omafilcon B)
15 minutes of daily wear.
• Lens B (comfilcon A)
15 minutes of daily wear.

Locations

Country	Name	City	State
Canada	University of Waterloo	Waterloo

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall fit acceptance	Overall fit acceptance will be measured on scale of (0-4) where (0=Should not be worn and 4=Perfect)	15 Minutes