A Study to Evaluate a Modified Contact Lens
Study Details
Study Description
Brief Summary
This study is being conducted to evaluate the product performance of SofLens daily disposable contact lenses packaged in an investigational Test solution versus SofLens daily disposable contact lenses packaged in the currently marketed solution (Control), as it relates to comfort when worn by adapted soft contact lens wearers on a daily-wear basis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SofLens in investigational solution Bausch + Lomb SofLens daily disposable contact lens packaged in an investigational storage solution. |
Device: SofLens in investigational solution
SofLens in investigational solution, worn on a daily disposable basis for 7 days.
|
| Active Comparator: SofLens in currently marketed solution SofLens daily disposable contact lens packaged in currently marketed storage solution. |
Device: SofLens in currently marketed solution
SofLens packaged in currently marketed solution, worn on a daily disposable basis for 7 days.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Eyes With > Grade 2 Slit Lamp Findings [At 2 weeks follow up]
Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding > grade 2, across abnormalities.
- Visual Acuity [At 2 weeks follow up]
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
Secondary Outcome Measures
- Symptoms and Complaints [At 2 weeks follow up]
Symptoms and complaints were assessed on a scale from 0 to 100, with 0 denoting the most unfavorable symptoms/complaints. Symptoms/complaints were collected by eye from each participant and based on the participant's experience with the study lenses. Symptoms/complaints parameters included the following: Burning/stinging upon insertion, Comfort upon insertion, Overall comfort, Comfort at end of day, Ease of handling/insertion, Ease of handling/removal, Dryness, Itchiness, Redness, Vision upon insertion, Vision, Vision in low light, Lens cleanness upon insertion, Lens cleanness upon removal, and Overall impression.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subjects must be free of any anterior segment disorders.
-
Subjects must be adapted lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand.
-
Subjects must be myopic and require contact lens correction from -0.50 D to -6.00 D in each eye.
-
Subjects must be habitual wearers of daily disposable or planned replacement (at least every 3 months) soft contact lenses.
-
Subjects must live/work in an urban environment at least 6 hours per day and for at least 4 days per week throughout the duration of the study.
-
Subjects must be willing and able to wear the study lenses on a daily wear basis while in an urban environment.
-
Subjects living/working in the urban environment must feel challenged by harsh, drying outdoor conditions (ie dust, pollution, smog).
-
Subjects must feel that being in an urban environment has a negative effect on their lens wearing experience.
-
Subjects must have access to an internet connection and be able to send and receive email.
Exclusion Criteria:
-
Subjects who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
-
Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
-
Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
-
Subjects with an active ocular disease or who are using any ocular medication.
-
Subjects with any grade 2 or greater finding during the slit lamp examination
-
Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
-
Subjects with any scar or neovascularization within the central 4 mm of the cornea. Subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study.
-
Subjects who are allergic to any component in the study care products.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bausch & Lomb, Inc. | Rochester | New York | United States | 14609 |
Sponsors and Collaborators
- Bausch & Lomb Incorporated
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 691
Study Results
Participant Flow
| Recruitment Details | There were 438 eligible participants (876 eyes) enrolled. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | SofLens in Investigational Solution | SofLens in Currently Marketed Solution |
|---|---|---|
| Arm/Group Description | Bausch + Lomb SofLens daily disposable contact lens packaged in an investigational storage solution. SofLens in investigational solution: SofLens in investigational solution, worn on a daily disposable basis for 7 days. | SofLens daily disposable contact lens packaged in currently marketed storage solution. SofLens in currently marketed solution: SofLens packaged in currently marketed solution, worn on a daily disposable basis for 7 days. |
| Period Title: Overall Study | ||
| STARTED | 222 | 216 |
| COMPLETED | 217 | 214 |
| NOT COMPLETED | 5 | 2 |
Baseline Characteristics
| Arm/Group Title | SofLens in Investigational Solution | SofLens in Currently Marketed Solution | Total |
|---|---|---|---|
| Arm/Group Description | Bausch + Lomb SofLens daily disposable contact lens packaged in an investigational storage solution. SofLens in investigational solution: SofLens in investigational solution, worn on a daily disposable basis for 7 days. | SofLens daily disposable contact lens packaged in currently marketed storage solution. SofLens in currently marketed solution: SofLens packaged in currently marketed solution, worn on a daily disposable basis for 7 days. | Total of all reporting groups |
| Overall Participants | 222 | 215 | 437 |
| Age (years) [Mean (Full Range) ] | |||
| Mean (Full Range) [years] |
27.9
|
27.2
|
27.6
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
164
73.9%
|
146
67.9%
|
310
70.9%
|
| Male |
58
26.1%
|
69
32.1%
|
127
29.1%
|
Outcome Measures
| Title | Percentage of Eyes With > Grade 2 Slit Lamp Findings |
|---|---|
| Description | Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding > grade 2, across abnormalities. |
| Time Frame | At 2 weeks follow up |
Outcome Measure Data
| Analysis Population Description |
|---|
| Dispensed eyes with nonmissing scores in each treatment group are included in the analysis population. |
| Arm/Group Title | SofLens in Investigational Solution | SofLens in Currently Marketed Solution |
|---|---|---|
| Arm/Group Description | Bausch + Lomb SofLens daily disposable contact lens packaged in an investigational storage solution. SofLens in investigational solution: SofLens in investigational solution, worn on a daily disposable basis for 7 days. | SofLens daily disposable contact lens packaged in currently marketed storage solution. SofLens in currently marketed solution: SofLens packaged in currently marketed solution, worn on a daily disposable basis for 7 days. |
| Measure Participants | 218 | 215 |
| Measure eyes | 436 | 430 |
| Count of Units [eyes] |
0
|
0
|
| Title | Visual Acuity |
|---|---|
| Description | Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR). |
| Time Frame | At 2 weeks follow up |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eyes assessed for visual acuity at the 2 week follow up visit are included in the analysis population. |
| Arm/Group Title | SofLens in Investigational Solution | SofLens in Currently Marketed Solution |
|---|---|---|
| Arm/Group Description | Bausch + Lomb SofLens daily disposable contact lens packaged in an investigational storage solution. SofLens in investigational solution: SofLens in investigational solution, worn on a daily disposable basis for 7 days. | SofLens daily disposable contact lens packaged in currently marketed storage solution. SofLens in currently marketed solution: SofLens packaged in currently marketed solution, worn on a daily disposable basis for 7 days. |
| Measure Participants | 203 | 200 |
| Measure eyes | 406 | 400 |
| Least Squares Mean (Standard Deviation) [logMAR] |
-0.051
(0.062)
|
-0.046
(0.061)
|
| Title | Symptoms and Complaints |
|---|---|
| Description | Symptoms and complaints were assessed on a scale from 0 to 100, with 0 denoting the most unfavorable symptoms/complaints. Symptoms/complaints were collected by eye from each participant and based on the participant's experience with the study lenses. Symptoms/complaints parameters included the following: Burning/stinging upon insertion, Comfort upon insertion, Overall comfort, Comfort at end of day, Ease of handling/insertion, Ease of handling/removal, Dryness, Itchiness, Redness, Vision upon insertion, Vision, Vision in low light, Lens cleanness upon insertion, Lens cleanness upon removal, and Overall impression. |
| Time Frame | At 2 weeks follow up |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eyes assessed for symptoms/complaints at the 2 week follow up visit are included in the analysis population. |
| Arm/Group Title | SofLens in Investigational Solution | SofLens in Currently Marketed Solution |
|---|---|---|
| Arm/Group Description | Bausch + Lomb SofLens daily disposable contact lens packaged in an investigational storage solution. SofLens in investigational solution: SofLens in investigational solution, worn on a daily disposable basis for 7 days. | SofLens daily disposable contact lens packaged in currently marketed storage solution. SofLens in currently marketed solution: SofLens packaged in currently marketed solution, worn on a daily disposable basis for 7 days. |
| Measure Participants | 217 | 213 |
| Measure eyes | 434 | 426 |
| Burning/stinging upon insertion |
83.2
(20.5)
|
86.8
(20.5)
|
| Comfort upon insertion |
78.2
(20.4)
|
82.7
(20.4)
|
| Overall comfort |
77.6
(21.0)
|
79.9
(20.9)
|
| Comfort at end of day |
70.3
(23.8)
|
70.5
(23.7)
|
| Ease of handling/insertion |
73.1
(24.1)
|
76.3
(24.1)
|
| Ease of handling/removal |
87.1
(16.2)
|
87.9
(16.2)
|
| Dryness |
74.2
(24.2)
|
74.5
(24.2)
|
| Itchiness |
84.5
(19.1)
|
87.7
(19.1)
|
| Redness |
86.3
(17.4)
|
89.2
(17.4)
|
| Vision upon insertion |
86.7
(14.4)
|
89.2
(14.4)
|
| Vision |
87.7
(14.2)
|
88.7
(14.2)
|
| Vision in low light |
85.4
(14.6)
|
86.7
(14.6)
|
| Lens cleanness upon insertion |
90.2
(14.2)
|
91.3
(14.2)
|
| Lens cleanness upon removal |
84.6
(15.5)
|
84.1
(15.5)
|
| Overall impression |
73.7
(21.2)
|
75.9
(21.1)
|
Adverse Events
| Time Frame | 6 weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse events were not coded. Therefore, source vocabulary is not applicable. There were 444 eyes dispensed test lenses and 432 eyes dispensed control lenses, assessed for adverse events. | |||
| Arm/Group Title | SofLens in Investigational Solution | SofLens in Currently Marketed Solution | ||
| Arm/Group Description | Bausch + Lomb SofLens daily disposable contact lens packaged in an investigational storage solution. SofLens in investigational solution: SofLens in investigational solution, worn on a daily disposable basis for 7 days. | SofLens daily disposable contact lens packaged in currently marketed storage solution. SofLens in currently marketed solution: SofLens packaged in currently marketed solution, worn on a daily disposable basis for 7 days. | ||
All Cause Mortality |
||||
| SofLens in Investigational Solution | SofLens in Currently Marketed Solution | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| SofLens in Investigational Solution | SofLens in Currently Marketed Solution | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/222 (0%) | 0/216 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| SofLens in Investigational Solution | SofLens in Currently Marketed Solution | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/222 (0%) | 0/216 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Contact sponsor directly for details.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Bausch Health |
| Phone | |
| robert.steffen@bausch.com |
- 691