Evaluation of Two Daily Disposable Contact Lenses.
Study Details
Study Description
Brief Summary
The objective of this clinical study is to evaluate the product performance of SofLens daily disposable contact lenses packaged in the investigational Test solution versus SofLens daily disposable contact lenses packaged in Control, solution as it relates to comfort when used by subjects who use technology devices (eg, Personal Digital Assistants [PDAs], computers, electronic game consoles, hand-held electronic devices, electronic book readers, etc) on an average of 4 hours per day over a week's time for a minimum of 4 days each week.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental- Soflens Bausch & Lomb experimental soflens daily disposable contact lens packaged in an investigational storage solution. |
Device: Experimental- Soflens
A new pair of lenses will be worn each day while the subject is in the study
|
| Active Comparator: Marketed - Soflens Bausch & Lomb daily disposable marketed soflens contact lens packaged with: 0.5% poloxamine in buffered saline solution. |
Device: Marketed - Soflens
A new pair of lenses will be worn each day while the subject is in the study.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Eyes With > Grade 2 Slit Lamp Findings [2 weeks]
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.
Secondary Outcome Measures
- Initial Lens Performance Survey [At dispensing]
A lens performance survey was given to each participant at the Screening/Dispensing Visit, three minutes following insertion of the study lenses. Lens performance was assessed by eye for the following parameters: burning/stinging upon insertion, comfort upon insertion, ease of handling/insertion, vision upon insertion, and lens cleanness upon insertion. As with symptoms/complaints, responses were on a scale from 0 to 100, with 0 being the most unfavorable score.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
-
Subjects must be free of any anterior segment disorders.
-
Subjects must be adapted soft contact 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 willing and able to wear the study lenses for at least 8 hours (12 hours or more is recommended) each day throughout the duration of the study.
-
Subjects must use a technologic device for an average of 4 hours per day over a week's time and at a minimum of 4 days per week.
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 corneal infiltrates, of ANY GRADE, are not eligible.
-
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 who have had any corneal surgery (eg, refractive surgery).
-
Subjects who are allergic to any component in the study care products.
-
Subjects may not use their habitual rewetting drops while participating in this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bausch & Lomb Incorporated | Rochester | New York | United States | 14609 |
Sponsors and Collaborators
- Bausch & Lomb Incorporated
Investigators
- Study Director: Beverly J Barna, CCRA, Bausch & Lomb Incorporated
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 642
Study Results
Participant Flow
| Recruitment Details | There were 441 participants (882 eyes) enrolled, 221 in the test group and 220 in the control group. There were 434 eligible participants (868 eyes) who participated in the study, 216 in the test group and 218 in the control group. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Experimental- Soflens | Marketed - Soflens |
|---|---|---|
| Arm/Group Description | Bausch & Lomb experimental soflens daily disposable contact lens packaged in an investigational storage solution. Experimental- Soflens: A new pair of lenses will be worn each day while the subject is in the study | Bausch & Lomb daily disposable marketed soflens contact lens packaged with: 0.5% poloxamine in buffered saline solution. Marketed - Soflens: A new pair of lenses will be worn each day while the subject is in the study. |
| Period Title: Overall Study | ||
| STARTED | 221 | 220 |
| COMPLETED | 215 | 217 |
| NOT COMPLETED | 6 | 3 |
Baseline Characteristics
| Arm/Group Title | Experimental- Soflens | Marketed - Soflens | Total |
|---|---|---|---|
| Arm/Group Description | Bausch & Lomb experimental soflens daily disposable contact lens packaged in an investigational storage solution. Experimental- Soflens: A new pair of lenses will be worn each day while the subject is in the study | Bausch & Lomb daily disposable marketed soflens contact lens packaged with: 0.5% poloxamine in buffered saline solution. Marketed - Soflens: A new pair of lenses will be worn each day while the subject is in the study. | Total of all reporting groups |
| Overall Participants | 215 | 216 | 431 |
| Age (years) [Mean (Full Range) ] | |||
| Mean (Full Range) [years] |
27.1
|
26.6
|
26.8
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
140
65.1%
|
153
70.8%
|
293
68%
|
| Male |
75
34.9%
|
63
29.2%
|
138
32%
|
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 | 2 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| There were 438 eyes in the test group and 434 eyes in the control group that were assessed for this outcome measure. |
| Arm/Group Title | Experimental- Soflens | Marketed - Soflens |
|---|---|---|
| Arm/Group Description | Bausch & Lomb experimental soflens daily disposable contact lens packaged in an investigational storage solution. Experimental- Soflens: A new pair of lenses will be worn each day while the subject is in the study | Bausch & Lomb daily disposable marketed soflens contact lens packaged with: 0.5% poloxamine in buffered saline solution. Marketed - Soflens: A new pair of lenses will be worn each day while the subject is in the study. |
| Measure Participants | 219 | 217 |
| Measure eyes | 438 | 434 |
| Count of Units [eyes] |
0
|
0
|
| Title | Initial Lens Performance Survey |
|---|---|
| Description | A lens performance survey was given to each participant at the Screening/Dispensing Visit, three minutes following insertion of the study lenses. Lens performance was assessed by eye for the following parameters: burning/stinging upon insertion, comfort upon insertion, ease of handling/insertion, vision upon insertion, and lens cleanness upon insertion. As with symptoms/complaints, responses were on a scale from 0 to 100, with 0 being the most unfavorable score. |
| Time Frame | At dispensing |
Outcome Measure Data
| Analysis Population Description |
|---|
| There were 426 eyes in the test group and 424 eyes in the control group that were assessed for this outcome measure. |
| Arm/Group Title | Experimental- Soflens | Marketed - Soflens |
|---|---|---|
| Arm/Group Description | Bausch & Lomb experimental soflens daily disposable contact lens packaged in an investigational storage solution. Experimental- Soflens: A new pair of lenses will be worn each day while the subject is in the study | Bausch & Lomb daily disposable marketed soflens contact lens packaged with: 0.5% poloxamine in buffered saline solution. Marketed - Soflens: A new pair of lenses will be worn each day while the subject is in the study. |
| Measure Participants | 213 | 212 |
| Measure eyes | 426 | 424 |
| Burning/stinging upon insertion |
91.6
(18.7)
|
91.0
(18.7)
|
| Comfort Upon Insertion |
83.8
(21.1)
|
83.9
(21.2)
|
| Ease of Handling/Insertion |
77.2
(26.2)
|
79.4
(26.3)
|
| Vision Upon Insertion |
89.3
(15.5)
|
88.4
(15.6)
|
| Lens Cleanness Upon Insertion |
95.4
(10.8)
|
94.9
(10.9)
|
Adverse Events
| Time Frame | 2 weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse events were not coded. Therefore, source vocabulary is not applicable.There were 440 eyes dispensed test lenses and 436 eyes dispensed control lenses, assessed for adverse events. | |||
| Arm/Group Title | Experimental- Soflens | Marketed - Soflens | ||
| Arm/Group Description | Bausch & Lomb experimental soflens daily disposable contact lens packaged in an investigational storage solution. Experimental- Soflens: A new pair of lenses will be worn each day while the subject is in the study | Bausch & Lomb daily disposable marketed soflens contact lens packaged with: 0.5% poloxamine in buffered saline solution. Marketed - Soflens: A new pair of lenses will be worn each day while the subject is in the study. | ||
All Cause Mortality |
||||
| Experimental- Soflens | Marketed - Soflens | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Experimental- Soflens | Marketed - Soflens | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/221 (0%) | 0/220 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Experimental- Soflens | Marketed - Soflens | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/221 (0%) | 0/220 (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 | 908-300-9920 |
| susan.harris@bauschhealth.com |
- 642