## Protocol Section
### Identification Module
**NCT ID:** NCT00710879

**Brief Title:** Evaluation of a Multi-Purpose Solution

**Official Title:** A Study to Evaluate the Clinical Performance of a Multi-Purpose Solution.

#### Organization Study ID Info
**ID:** 568
#### Organization
**Class:** INDUSTRY
**Full Name:** Bausch & Lomb Incorporated
### Status Module
#### Completion Date
**Date:** 2009-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2011-12-13

**Type:** ESTIMATED

**Last Update Submit Date:** 2011-12-07

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2009-02

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2011-02-08

**Type:** ESTIMATED

**Results First Submit Date:** 2011-01-14

**Results First Submit QC Date:** 2011-01-14

#### Start Date
**Date:** 2008-07

**Status Verified Date:** 2011-12

#### Study First Post Date
**Date:** 2008-07-08
**Type:** ESTIMATED
**Study First Submit Date:** 2008-06-30
**Study First Submit QC Date:** 2008-07-07
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Bausch & Lomb Incorporated

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study evaluates a multi-purpose solution when used on a daily wear basis by currently adapted soft contact lens wearers.

### Conditions Module

**Conditions:**

- Contact Lens Solutions

**Keywords:**

- Efficacy

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 180

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Multi-purpose solution administered to adapted FDA group I soft contact lens wearers and FDA group IV soft contact lens wearers.

**Intervention Names:**

- Device: Bausch & Lomb Multi-Purpose Solution

**Label:** Multipurpose Solution

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Multipurpose Solution

**Description:** Daily care for contact lenses.

**Name:** Bausch & Lomb Multi-Purpose Solution

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Excellent = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora \<0-103 CFU/mL. Good = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora \<103-105 CFU/mL. Skeptical = Bacterial infection suspected and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. No Efficacy = Bacterial infection definite and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. Pathogens were H. aegyptius, H. influenzae, Moraxella spp., P. aeruginosa, S. pneumoniae, S. aureus, N. gonorrhoeae

**Measure:** Antimicrobial Efficacy

**Time Frame:** 2 weeks, 3 months

#### Secondary Outcomes

**Description:** Very Safe = No solution related AEs and no changes in lens properties related to the solution. Safe = No solution related AEs and slight change in lens properties related to the solution, but lens wear was continued. Skeptical = Solution related AEs were suspected and lens properties changed due to the solution and lens wear was discontinued. Not Safe = Solution related AEs were present and lens properties changed due to the solution and lens wear was discontinued.

**Measure:** Solution Related AE's and Lens Changes

**Time Frame:** 3 months, 6 months

**Description:** The Utility was determined based on the results of the efficacy and safety evaluations.

**Measure:** Solution Utlility

**Time Frame:** 3 months, 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Is an adapted Group I or Group IV soft contact lens wearer and agrees to wear the study lenses on a daily wear basis.
* Must be able and willing to comply with all treatment and follow-up study procedures.
* Must have a clear central cornea.
* VA correctable to 0.3 LogMar or better (driving vision)

Exclusion Criteria:

* Systemic disease affecting ocular health.
* Using systemic or topical medications.
* Wear monovision, multifocal or toric contact lenses.
* Any grade 2 or greater slit lamp findings.
* Pregnancy

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Torrance

**Country:** United States

**Facility:** Dr. Nicholas Marsico

**State:** California

**Zip:** 90505

#### Overall Officials

**Official 1:**

**Affiliation:** Bausch & Lomb Incorporated

**Name:** Bev Barna

**Role:** STUDY_DIRECTOR

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Multi-purpose Solution and Optima 38 Lenses

**Description:** Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.

**ID:** EG000

**Other Num at Risk:** 120

**Serious Number At Risk:** 120

**Title:** Multi-purpose Solution and Optima 38 Lenses

**Group ID:** EG001

**Title:** Multi-Purpose Solution and Acuvue 2 Lenses

**Description:** B\&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.

**ID:** EG001

**Other Num at Risk:** 240

**Serious Number At Risk:** 240

**Title:** Multi-Purpose Solution and Acuvue 2 Lenses

**Frequency Threshold:** 5

**Time Frame:** Adverse events were evaluated at every visit. Group 1, 3 months and group 4, 6 months.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 60

**Group ID:** BG001

**Value:** 117

**Group ID:** BG002

**Value:** 177

**Units:** Participants

### Group

**ID:** BG000

**Title:** Multi-purpose Solution and Optima 38 Lenses

**Description:** Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.

### Group

**ID:** BG001

**Title:** Multi-Purpose Solution and Acuvue 2 Lenses

**Description:** B\&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 11.0

**Value:** 60

#### Measurement

**Group ID:** BG001

**Spread:** 10.3

**Value:** 117

#### Measurement

**Group ID:** BG002

**Value:** 177

**Class Title:** Aged 18-64

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 37

#### Measurement

**Group ID:** BG001

**Value:** 75

#### Measurement

**Group ID:** BG002

**Value:** 112

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 23

#### Measurement

**Group ID:** BG001

**Value:** 42

#### Measurement

**Group ID:** BG002

**Value:** 65

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 11

#### Measurement

**Group ID:** BG002

**Value:** 11

**Class Title:** 1 Grandparent

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 18

#### Measurement

**Group ID:** BG002

**Value:** 25

**Class Title:** 2 Grandparents

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 6

#### Measurement

**Group ID:** BG002

**Value:** 10

**Class Title:** 3 Grandparents

#### Measurement

**Group ID:** BG000

**Value:** 49

#### Measurement

**Group ID:** BG001

**Value:** 82

#### Measurement

**Group ID:** BG002

**Value:** 131

**Class Title:** 4 Grandparents

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** NUMBER
**Title:** Age, Customized
**Unit of Measure:** Participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Description:** Participants with Grandparents Born in Japan
**Parameter Type:** NUMBER
**Title:** Participants with Grandparents Born in Japan
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**Other Details:** All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee are completed. The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** joseph.t.barr@bausch.com
**Organization:** Bausch & Lomb Incorporated
**Phone:** (585) 338-6439
**Title:** Joseph Barr, OD, MS
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 114
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 219
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 118
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 238
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 112
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 225
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Excellent = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora \<0-103 CFU/mL. Good = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora \<103-105 CFU/mL. Skeptical = Bacterial infection suspected and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. No Efficacy = Bacterial infection definite and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. Pathogens were H. aegyptius, H. influenzae, Moraxella spp., P. aeruginosa, S. pneumoniae, S. aureus, N. gonorrhoeae
**Parameter Type:** NUMBER
**Population Description:** All eligible, dispensed eyes with cultures taken within window. Group I subjects were cultured at the 3-Month Visit. Group IV subjects were cultured at the 2-week Follow-up visit.
**Reporting Status:** POSTED
**Time Frame:** 2 weeks, 3 months
**Title:** Antimicrobial Efficacy
**Type:** PRIMARY
**Type Units Analyzed:** eyes
**Unit of Measure:** Eyes
##### Group
**Description:** Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.
**ID:** OG000
**Title:** Multi-purpose Solution and Optima 38 Lenses
##### Group
**Description:** B\&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
**ID:** OG001
**Title:** Multi-Purpose Solution and Acuvue 2 Lenses
#### Outcome Measure 2
**Description:** Very Safe = No solution related AEs and no changes in lens properties related to the solution. Safe = No solution related AEs and slight change in lens properties related to the solution, but lens wear was continued. Skeptical = Solution related AEs were suspected and lens properties changed due to the solution and lens wear was discontinued. Not Safe = Solution related AEs were present and lens properties changed due to the solution and lens wear was discontinued.
**Parameter Type:** NUMBER
**Population Description:** All Eligible, Dispensed Eyes
**Reporting Status:** POSTED
**Time Frame:** 3 months, 6 months
**Title:** Solution Related AE's and Lens Changes
**Type:** SECONDARY
**Type Units Analyzed:** eyes
**Unit of Measure:** Eyes
##### Group
**Description:** Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.
**ID:** OG000
**Title:** Multi-purpose Solution and Optima 38 Lenses
##### Group
**Description:** B\&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
**ID:** OG001
**Title:** Multi-Purpose Solution and Acuvue 2 Lenses
#### Outcome Measure 3
**Description:** The Utility was determined based on the results of the efficacy and safety evaluations.
**Parameter Type:** NUMBER
**Population Description:** All Eligible, Dispensed Eyes
**Reporting Status:** POSTED
**Time Frame:** 3 months, 6 months
**Title:** Solution Utlility
**Type:** SECONDARY
**Type Units Analyzed:** Eyes
**Unit of Measure:** Eyes
##### Group
**Description:** Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.
**ID:** OG000
**Title:** Multi-purpose Solution and Optima 38 Lenses
##### Group
**Description:** B\&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
**ID:** OG001
**Title:** Multi-Purpose Solution and Acuvue 2 Lenses
### Participant Flow Module
#### Group
**Description:** Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.
**ID:** FG000
**Title:** Multi-purpose Solution and Optima 38 Lenses
#### Group
**Description:** B\&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
**ID:** FG001
**Title:** Multi-Purpose Solution and Acuvue 2 Lenses
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Protocol Violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 60
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 117
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 58
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 113
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 4
**Pre-Assignment Details:** This study focused on participants of Japanese descent (at least one grandparent born in Japan) for a minimum of 20% of total enrollment. 180 participants were enrolled, 3 participants were ineligible at screening, 177 participants were eligible at the start of the study.
**Recruitment Details:** First participant was enrolled in this study on 07/07/2008 and last subject exited on 02/02/2009. 180 participants were enrolled at 9 investigative sites in the United States.
**Has Results:** True