## Protocol Section
### Identification Module
**NCT ID:** NCT06431061

**Brief Title:** Clinical Evaluation of Proclear Toric and Biofinity Toric

**Official Title:** Clinical Evaluation of Proclear Toric and Biofinity Toric

#### Organization Study ID Info
**ID:** EX-MKTG-158
#### Organization
**Class:** INDUSTRY
**Full Name:** Coopervision, Inc.
### Status Module
#### Completion Date
**Date:** 2024-08-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-08-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Coopervision, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

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

**Detailed 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.

### Conditions Module

**Conditions:**

- Astigmatism

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Single

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** All participants will wear lens A for 15 minutes (Period 1).

**Intervention Names:**

- Device: Lens A (omafilcon B)

**Label:** Lens A (omafilcon B)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** All participants will wear lens B for 15 minutes (Period 2).

**Intervention Names:**

- Device: Lens B (comfilcon A)

**Label:** Lens B (comfilcon A)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Lens A (omafilcon B)

**Description:** 15 minutes of daily wear.

**Name:** Lens A (omafilcon B)

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Lens B (comfilcon A)

**Description:** 15 minutes of daily wear.

**Name:** Lens B (comfilcon A)

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Overall fit acceptance will be measured on scale of (0-4) where (0=Should not be worn and 4=Perfect)

**Measure:** Overall fit acceptance

**Time Frame:** 15 Minutes

### Eligibility Module

**Eligibility Criteria:** 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).

**Minimum Age:** 17 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Waterloo

**Country:** Canada

**Facility:** University of Waterloo

#### Overall Officials

**Official 1:**

**Affiliation:** Centre for Ocular Research and Education

**Name:** Lyndon Jones

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012030

- Term: Refractive Errors

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4558

- Name: Astigmatism

- Relevance: HIGH

- As Found: Astigmatism

- ID: M14872

- Name: Refractive Errors

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001251

- Term: Astigmatism

### Misc Info Module

- Version Holder: 2024-05-31
