## Protocol Section
### Identification Module
**NCT ID:** NCT00639379

**Brief Title:** Comparison of Two Toric Contact Lenses on Current Toric Wearers

**Official Title:** A Multi-Center, Subject Masked, Randomized, Two Week Crossover Design, Investigation of the Acuvue Cypress Toric Silicone Hydrogel Lens Compared to the Bausch & Lomb SofLens66® Toric Hydrophilic Lens

#### Organization Study ID Info
**ID:** CR-0802
#### Organization
**Class:** INDUSTRY
**Full Name:** Johnson & Johnson Vision Care, Inc.
### Status Module
#### Completion Date
**Date:** 2008-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-05-21

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-05-05

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2008-06

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2010-07-19

**Type:** ESTIMATED

**Results First Submit Date:** 2010-06-18

**Results First Submit QC Date:** 2010-06-18

#### Start Date
**Date:** 2008-02

**Status Verified Date:** 2015-05

#### Study First Post Date
**Date:** 2008-03-20
**Type:** ESTIMATED
**Study First Submit Date:** 2008-03-13
**Study First Submit QC Date:** 2008-03-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Johnson & Johnson Vision Care, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to evaluate and compare the clinical performance of two toric contact lenses amongst 110 subjects, 2-week, single masked (subject), daily wear, randomized, bilateral, crossover study; 4 weeks duration. Hypotheses include equal or better performance of the test lens over the control lenses for comfort, vision, and toric fit characteristics as well as corneal integrity

**Detailed Description:** Up to 7 sites in the US will participate. Each investigator will have both test and control lens types. There will be a maximum of 6 scheduled visits:

Visit 1: Habitual lens evaluation / Baseline / Trial fitting Visit 2: Dispensing (to be combined with Visit 1 where possible), Visit 3: Questionnaire only (no exam) 7 days (±2) after dispensing, Visit 4: 2 week follow-up 14 days (±3) after dispensing, and dispense second lens type, Visit 5: Questionnaire only (no exam) 7 days (±2) after 2nd lens dispense, Visit 6: 2 week follow-up 14 days (±3) after 2nd lens dispense

### Conditions Module

**Conditions:**

- Ametropia

**Keywords:**

- toric contact lenses

- vision

- comfort

- toric fit characteristics

- slit lamp findings

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 89

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** senofilcon A toric daily wear contact lenses

**Intervention Names:**

- Device: senofilcon A toric

**Label:** senofilcon A

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** alphafilcon A toric daily wear contact lenses

**Intervention Names:**

- Device: alphafilcon A toric

**Label:** alphafilcon A

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- senofilcon A

**Description:** silicone hydrogel toric lens, 2 wk replacement, daily wear

**Name:** senofilcon A toric

**Other Names:**

- ACUVUE OASYS

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- alphafilcon A

**Description:** hydrogel toric lens, 2 wk replacement, daily wear

**Name:** alphafilcon A toric

**Other Names:**

- SofLens Toric

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Number of eyes with lens orientation within 5 degrees of optimal orientation within 1 minute of contact lens insertion.

**Measure:** Lens Orientation Within 5 Degrees

**Time Frame:** 1 minute after insertion

**Description:** Number of eyes with the amount of rotation induced from a blink within 5 degrees of settled orientation.

**Measure:** Lens Stability

**Time Frame:** 10-15 minutes after insertion

**Description:** A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control. \>0=comfortable, \<0=uncomfortable.

**Measure:** Subjective Lens Comfort

**Time Frame:** 1 and 2 weeks

**Description:** A weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive response, was used to derive vision outcomes. The analysis shows the difference in outcome between the test and control. \>0=satisfactory vision, \<0=unsatisfactory vision.

**Measure:** Subjective Vision

**Time Frame:** 1 and 2 weeks

**Description:** Corneal staining measured using the National Eye Institute grading scale of grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.

**Measure:** Overall Corneal Staining

**Time Frame:** after 2 weeks use

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Be at least 18 and less than or equal to 45 years of age, have a need for vision correction and wear contact lenses in BOTH eyes (monovision or uni-ocular fitting is NOT allowed).
2. Be able to read J1 at near WITHOUT the aid of a near addition over the distance prescription.
3. Be a currently successful wearer for at least 3 months of B\&L SofLens 66 Toric hydrogel lenses.
4. Be able and willing to adhere to the instructions set forth in the protocol.
5. Agree to wear their contact lenses in both eyes on a daily wear schedule for at least 8 hours per day every day during the study.
6. Have a distance spectacle spherical component between -1.00 D and -5.25 D with cylinder in the range of 0.75 D to 2.25 D and cylinder axis within 10 ° of the vertical and within 30° of the horizontal in both eyes (when the subject's prescription is presented in minus cylinder form).
7. Have a best corrected manifest refraction visual acuity of at least 20/25 or better in each eye.
8. Be in good general health, based on his/her knowledge.
9. Must be given an explanation of the study objectives, lens and solutions usage requirements and visit schedule. The subject must read, indicate understanding of and agree to begin participation in the clinical study. The subject must then sign the Informed Consent Form in the presence of the Investigator or their designee.

Exclusion Criteria:

1. Presbyopic or has the need for a near add for reading.
2. Previous refractive surgery; current or previous orthokeratology treatment.
3. Aphakia, keratoconus or a highly irregular cornea.
4. The presence of ocular or systemic disease or has the need for medication (ocular or systemic) which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (e.g., Sjögren's syndrome, type II diabetes, allergies).
5. A known history of corneal hypoesthesia (reduced corneal sensitivity.)
6. Anterior uveitis or iritis (past or present).
7. A history of recurrent erosions, corneal infiltrates corneal ulcer or fungal infections.
8. Clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations or infections of the eye, eyelids, or associated structures.
9. Slit lamp findings that would contraindicate contact lens wear such as:

   * Pathological dry eye or associated findings
   * Pterygium or corneal scars within the visual axis
   * Neovascularization \>1mm in from the limbus
   * History of giant papillary conjunctivitis (GPC) worse than Grade 2
   * Meibomian gland dysfunction, blepharitis, or seborrhoeic dermatitis
10. Current pregnancy or lactation (to the best of the subject's knowledge).
11. Actively participating in another clinical study at any time during this study.

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Jacksonville

**Country:** United States

**Facility:** Ted Brink and Associates

**State:** Florida

**Zip:** 32256

**Location 2:**

**City:** Orlando

**Country:** United States

**Facility:** Eola Eyes

**State:** Florida

**Zip:** 32801

**Location 3:**

**City:** Morrow

**Country:** United States

**Facility:** Clayton Eye Center

**State:** Georgia

**Zip:** 30260

**Location 4:**

**City:** St Louis

**Country:** United States

**Facility:** The Koetting Associates Inc.

**State:** Missouri

**Zip:** 63144

**Location 5:**

**City:** Concord

**Country:** United States

**Facility:** Southern Eyes

**State:** North Carolina

**Zip:** 28025

**Location 6:**

**City:** Beachwood

**Country:** United States

**Facility:** Western Reserve Vision Care

**State:** Ohio

**Zip:** 44122

**Location 7:**

**City:** Brentwood

**Country:** United States

**Facility:** Primary Eyecare Group, P.C.

**State:** Tennessee

**Zip:** 37027

## Derived Section

### Condition Browse Module - Ancestors

- 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: M14872

- Name: Refractive Errors

- Relevance: HIGH

- As Found: Ametropia

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012030

- Term: Refractive Errors

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Senofilcon A Toric / Alphafilcon A Toric

**Description:** senofilcon A toric work bilaterally during first 2-week period, alphafilcon A toric work bilaterally during second 2-week period.

**ID:** EG000

**Other Num at Risk:** 44

**Serious Number At Risk:** 44

**Title:** Senofilcon A Toric / Alphafilcon A Toric

**Group ID:** EG001

**Title:** Alphafilcon A Toric / Senofilcon A Toric

**Description:** alphafilcon A toric work bilaterally during first 2-week period, senofilcon A toric work bilaterally during second 2-week period.

**ID:** EG001

**Other Num at Risk:** 45

**Serious Number At Risk:** 45

**Title:** Alphafilcon A Toric / Senofilcon A Toric

**Frequency Threshold:** 5

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 84

**Units:** Participants

### Group

**ID:** BG000

**Title:** Total Completed Participants

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 8.05

**Value:** 31.6

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 53

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 31

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**Other Details:** The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Organization:** Vistakon
**Phone:** 904-443-3088
**Title:** Kurt Moody, OD
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 0.436
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 98.98
**CI Upper Limit:** 0.967
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Odds ratio is senofilcon A toric / alphafilcon A toric.
**Group Description:** Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for proportion of eyes with lens orientation within 5 degrees.
**Non-Inferiority Comment:** Non-inferiority margin is 0.65
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 0.967
**Statistical Comment:** 
**Statistical Method:** Regression, Logistic
**Tested Non-Inferiority:** True
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 0.680
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 98.98
**CI Upper Limit:** 1.416
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Odds ratio is senofilcon A toric / alphafilcon A toric.
**Group Description:** Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for proportion of eyes with lens stability within 5 degrees.
**Non-Inferiority Comment:** Non-inferiority margin = 0.65
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 1.416
**Statistical Comment:** 
**Statistical Method:** Regression, Logistic
**Tested Non-Inferiority:** True
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** -0.0517
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 98.98
**CI Upper Limit:** 0.1868
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.0921
**Estimate Comment:** The mean difference is calculated as senofilcon A toric minus alphafilcon A toric.
**Group Description:** Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for lens comfort.
**Non-Inferiority Comment:** Non-inferiority margin = -0.4
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 0.1868
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** True
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** -0.2337
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 98.98
**CI Upper Limit:** -0.01185
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.08566
**Estimate Comment:** The mean difference is calculated as senofilcon A toric minus alphafilcon A toric.
**Group Description:** Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for subjective vision.
**Non-Inferiority Comment:** Non-inferiority margin = -0.4
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.01185
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** True
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** -0.01267
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 98.98
**CI Upper Limit:** 0.01986
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.01265
**Estimate Comment:** The mean difference was calculated as senofilcon A toric minus alphafilcon A toric.
**Group Description:** Alternative hypothesis is senofilcon A toric is non-inferior to alphafilcon A toric by having a lower level of corneal staining.
**Non-Inferiority Comment:** Non-inferiority margin = 0.5
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.01267
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** True
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 128
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 128
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 144
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 138
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.08771
- **Upper Limit:** 
- **Value:** 0.08125
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.08771
- **Upper Limit:** 
- **Value:** -0.1055
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.08885
- **Upper Limit:** 
- **Value:** -0.0420
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.08885
- **Upper Limit:** 
- **Value:** -0.0302
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.01174
- **Upper Limit:** 
- **Value:** 0.04921
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.01176
- **Upper Limit:** 
- **Value:** 0.06188
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Number of eyes with lens orientation within 5 degrees of optimal orientation within 1 minute of contact lens insertion.
**Parameter Type:** NUMBER
**Population Description:** Subjects/eyes that completed the study were analyzed. A total of 168 eyes/84 subjects were analyzed.
**Reporting Status:** POSTED
**Time Frame:** 1 minute after insertion
**Title:** Lens Orientation Within 5 Degrees
**Type:** PRIMARY
**Unit of Measure:** Eyes
##### Group
**ID:** OG000
**Title:** Senofilcon A Toric
##### Group
**ID:** OG001
**Title:** Alphafilcon A Toric
#### Outcome Measure 2
**Description:** Number of eyes with the amount of rotation induced from a blink within 5 degrees of settled orientation.
**Parameter Type:** NUMBER
**Population Description:** Subjects/eyes that completed the study were analyzed. A total of 168 eyes/84 subjects were analyzed.
**Reporting Status:** POSTED
**Time Frame:** 10-15 minutes after insertion
**Title:** Lens Stability
**Type:** PRIMARY
**Unit of Measure:** Eyes
##### Group
**ID:** OG000
**Title:** Senofilcon A Toric
##### Group
**ID:** OG001
**Title:** Alphafilcon A Toric
#### Outcome Measure 3
**Description:** A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control. \>0=comfortable, \<0=uncomfortable.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Subjects that completed the study were analyzed.
**Reporting Status:** POSTED
**Time Frame:** 1 and 2 weeks
**Title:** Subjective Lens Comfort
**Type:** PRIMARY
**Unit of Measure:** Units on a scale
##### Group
**ID:** OG000
**Title:** Senofilcon A Toric
##### Group
**ID:** OG001
**Title:** Alphafilcon A Toric
#### Outcome Measure 4
**Description:** A weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive response, was used to derive vision outcomes. The analysis shows the difference in outcome between the test and control. \>0=satisfactory vision, \<0=unsatisfactory vision.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Subjects that completed the study were analyzed.
**Reporting Status:** POSTED
**Time Frame:** 1 and 2 weeks
**Title:** Subjective Vision
**Type:** PRIMARY
**Unit of Measure:** Units on a scale
##### Group
**ID:** OG000
**Title:** Senofilcon A Toric
##### Group
**ID:** OG001
**Title:** Alphafilcon A Toric
#### Outcome Measure 5
**Description:** Corneal staining measured using the National Eye Institute grading scale of grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Subjects that completed the study were analyzed.
**Reporting Status:** POSTED
**Time Frame:** after 2 weeks use
**Title:** Overall Corneal Staining
**Type:** PRIMARY
**Unit of Measure:** Units on a scale
##### Group
**ID:** OG000
**Title:** Senofilcon A Toric
##### Group
**ID:** OG001
**Title:** Alphafilcon A Toric
### Participant Flow Module
#### Group
**Description:** senofilcon A toric work bilaterally during first 2-week period, alphafilcon A toric work bilaterally during second 2-week period.
**ID:** FG000
**Title:** Senofilcon A Toric / Alphafilcon A Toric
#### Group
**Description:** alphafilcon A toric work bilaterally during first 2-week period, senofilcon A toric work bilaterally during second 2-week period.
**ID:** FG001
**Title:** Alphafilcon A Toric / Senofilcon A Toric
#### Period
**Title:** Period 1 - 2 Weeks
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** lens issue
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 44
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 45
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 39
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 45
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
#### Period
**Title:** Period 2 - 2 Weeks
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 39
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 45
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 39
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 45
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Has Results:** True