Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and effectiveness of an investigational multi-purpose contact lens solution.
A new multi-purpose solution has been developed for optimal lens disinfection and lens wearing comfort, compatible with a wide variety of commercially available lenses. Ten investigative sites were selected to evaluate 274 soft contact lens wearers in a parallel group study of one investigational multi-purpose solution and one marketed predicate solution.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational MPS | Experimental | Investigational multipurpose disinfecting solution (study MPS) |
|
| Predicate MPS | Active Comparator | Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational MPS | Device | Multi-purpose solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Lens Cleanliness as Measured by Light Reflectance | Lens cleanliness was assessed by total light reflectance, which is a computerized quantitative assessment conducted in a laboratory. The amount of light that scattered off the lens surface in a light field and was assessed using a light reflectance score that ranged from 0 (maximum lens cleanliness; clean/clear) to100 (minimum lens cleanliness; dirty/opaque). | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With no Corneal Staining | Corneal staining was performed via slit lamp observation of the corneal through a cobalt blue filter and a yellow #12 or #15 filter Wratten filter following contact lens removal and installation of standard sodium fluorescein. | Day 180 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nicholas Tarantino, OD | Abbott Medical Optics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complete Family Vision Center | San Diego | California | 92123 | United States | ||
| Eye Care Associates of Hawaii |
Not provided
Subjects for this study were chosen from the normal hydrogel contact lens-wearing patient populations at each of the investigational sites according to the following inclusion and exclusion criteria.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Investigational MPS | Investigational multipurpose disinfecting solution (study MPS) |
| FG001 | Predicate MPS | Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Investigational MPS | Investigational multipurpose disinfecting solution (study MPS) |
| BG001 | Predicate MPS | Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Lens Cleanliness as Measured by Light Reflectance | Lens cleanliness was assessed by total light reflectance, which is a computerized quantitative assessment conducted in a laboratory. The amount of light that scattered off the lens surface in a light field and was assessed using a light reflectance score that ranged from 0 (maximum lens cleanliness; clean/clear) to100 (minimum lens cleanliness; dirty/opaque). | Lens cleanliness analysis could only be done on subjects whose lenses were returned for analysis. Out of 270 subjects, 253 returned their study lenses to the sponsor for lab analysis (169 + 84 = 253). | Posted | Mean | Standard Deviation | light reflectance score | Day 30 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Investigational MPS | Investigational multipurpose disinfecting solution (study MPS) |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Red eye | Eye disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eugenia Thomas, O.D. | Abbott Medical Optics | 714-247-8723 | eugenia.thomas@amo.abbott.com |
Not provided
Not provided
Not provided
Not provided
Not provided
| Opti-Free | Device | Multi-purpose solution |
|
|
| Waipahu |
| Hawaii |
| 96797 |
| United States |
| Insight Eyecare | Warrensburg | Missouri | 64093 | United States |
| Drs. Quinn, Quinn & Associates | Athens | Ohio | 45701 | United States |
| Western Reserve Vision Care | Beachwood | Ohio | 44122 | United States |
| Central Ohio Eyecare | Columbus | Ohio | 43202 | United States |
| Northeastern Eye Institute | Scranton | Pennsylvania | 18503 | United States |
| West Bay Eye Associates | Warwick | Rhode Island | 02888 | United States |
| Ziegler Leffingwell Eyecare | West Allis | Wisconsin | 53227 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Predicate MPS |
Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS) |
|
|
| Secondary | Number of Subjects With no Corneal Staining | Corneal staining was performed via slit lamp observation of the corneal through a cobalt blue filter and a yellow #12 or #15 filter Wratten filter following contact lens removal and installation of standard sodium fluorescein. | Posted | Number | participants | Day 180 |
|
|
|
| 0 |
| 177 |
| 6 |
| 177 |
| EG001 | Predicate MPS | Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS) | 0 | 93 | 12 | 93 |
| Conjunctivitis | Eye disorders | Systematic Assessment |
|
| Corneal infiltrates | Eye disorders | Systematic Assessment |
|
| Corneal ulcer | Eye disorders | Systematic Assessment |
|
| Foreign body sensation | Eye disorders | Systematic Assessment |
|
| Seasonal eye allergies | Eye disorders | Systematic Assessment | Seasonal eye allergies may also cause dry eyes, redness, blurry vision, and light sensitivity |
|
| Keratitis | Eye disorders | Systematic Assessment |
|
| Superficial punctate keratopathy | Eye disorders | Systematic Assessment |
|
| Giant papillary conjunctivitis | Eye disorders | Systematic Assessment |
|
| Recurrent corneal erosion | Eye disorders | Systematic Assessment |
|
| Hypersensitivity to study solution | Eye disorders | Systematic Assessment |
|
| Hordeolum | Eye disorders | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to publication release and can embargo communications regarding trials results for a period that is more than 90 days but less than or equal to 18 months from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.