A Bilateral Dispensing Clinical Trial of an Sapphire Lens Against Senofilcon A Toric for Astigmatism Lens

NCT ID: NCT02555098

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-04-30

Brief Summary

This study was conducted to evaluate the clinical performance of an investigational silicone-hydrogel lens against Senofilcon A toric lens.

The study results were not used for design validation of the investigational product.

Detailed Description

This will be a randomized, bilateral, 2-week cross-over, double-masked, dispensing study comparing the investigational test lens against the Senofilcon A Toric for Astigmatism control lens.

Conditions

Astigmatism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sapphire contact lenses

Each subject randomized to wear either the Investigational lenses (test) or senofilcon A contact lenses (control) as a matched pair and cross over to the second matched pair.

Group Type: EXPERIMENTAL

Sapphire contact lenses

Intervention Type: DEVICE

Each subject randomized to wear either the test or control contact lenses as a matched pair and cross over to the second matched pair

senofilcon A

Each subject randomized to wear either the Investigational lenses (test) or senofilcon A contact lenses (control) as a matched pair and cross over to the second matched pair.

Group Type: ACTIVE_COMPARATOR

senofilcon A contact lenses

Intervention Type: DEVICE

Each subject randomized to wear either the test or control contact lenses as a matched pair and cross over to the second matched pair

Interventions

Sapphire contact lenses

Each subject randomized to wear either the test or control contact lenses as a matched pair and cross over to the second matched pair

Intervention Type: DEVICE

senofilcon A contact lenses

Each subject randomized to wear either the test or control contact lenses as a matched pair and cross over to the second matched pair

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• A person is eligible for inclusion in the study if they:

1. Are at least 18 years of age and have full legal capacity to volunteer;

2. Have read and signed an information consent letter;

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

4. Are an adapted soft contact lens wearer;

5. Require spectacle lens powers in both eyes;

1. Sphere: between -1.75 to -6.00 diopters and

2. Astigmatism: between -1.00 to -2.25 and

3. Axis: 180 ± 20 degrees

6. Are willing to wear contact lenses in both eyes;

7. Have manifest refraction visual acuities (VA) equal to or better than logMAR (log of the minimum angle of resolution) equivalent of 20/25 in each eye;

8. To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit including toric orientation as acceptable.

Exclusion Criteria

• A person will be excluded from the study if they:

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

2. Have any known active* ocular disease and/or infection;

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. Are pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);

7. Are aphakic;

8. Have undergone refractive error surgery;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michel Guillon

Role: PRINCIPAL_INVESTIGATOR

Ocular Technology Group

Locations

Family Eye Care Center

Campbell, California, United States

Countries

United States

Other Identifiers

CV-15-15

Identifier Type: -

Identifier Source: org_study_id