A Study to Evaluate the Product Performance of a Daily Disposable Contact Lens
Study Details
Study Description
Brief Summary
The objective of the study is to evaluate the product performance of visual acuity of the Bausch + Lomb investigational daily disposable contact lenses compared to the currently marketed Johnson & Johnson Acuvue Moist contact lenses.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Bausch & Lomb new daily disposable New daily disposable contact lenses |
Device: Bausch & Lomb new daily disposable
Test lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis.
|
| Active Comparator: Johnson & Johnson Acuvue Moist Contact lenses |
Device: Johnson & Johnson Acuvue Moist
Control lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis.
|
Outcome Measures
Primary Outcome Measures
- Visual Acuity [Dispensing Visit and 1 week follow-up]
Distance High contrast logMAR visual acuity (VA), difference between the test and control lens at dispensing visit and 1 week follow-up, crossover visit and 1 week follow-up.
- Slit Lamp Examination > Grade 2 [All study visits from screening through 2 week follow-up]
Slit lamp findings for each eye will be assessed at each study visit, including epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates, will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Slit lamp > 2.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subjects must be adapted soft contact lens wearers that are interested in daily disposable wear or currently adapted daily disposable soft contact lens wearers.
-
Subjects must agree to wear study lenses on a daily disposable basis for approximately one week and crossover to wear another study lens for one week.
-
Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
-
Subjects must have clear central corneas that are free of any anterior segment disorders.
-
Subjects must be myopic and require lens correction from -1.00 D to -6.00 diopters (D) in each eye.
Exclusion Criteria:
-
Subjects who have worn gas permeable contact lenses within the last 30 days or who have worn polymethylmethacrylate lenses within the last 3 months.
-
Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an affect 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 who are not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.
-
Subjects who currently wear monovision, multifocal, or toric contact lenses.
-
Subjects with an ocular astigmatism of 1.00 D or greater in either eye.
-
Subjects with anisometropia (spherical equivalent) of greater than 1.00 D.
-
Subjects with any grade 2 or greater finding during the slit lamp examination (refer to Appendix B for methods of clinical evaluation).
-
Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
-
Subjects with any "Present" finding during the slit lamp examination (refer to Appendix B for methods of clinical evaluation) 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 aphakic.
-
Subjects who are amblyopic.
-
Subjects who have presbyopia.
-
Subjects who have had any corneal surgery (eg, refractive surgery).
-
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 | Rochester | New York | United States | 14609 |
Sponsors and Collaborators
- Bausch & Lomb Incorporated
Investigators
- Study Director: Bev Barna, Bausch & Lomb Incorporated
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 662
Study Results
Participant Flow
| Recruitment Details | This was a two week, multicenter, open label, bilateral, crossover study. First Participant was enrolled 08/23/2010 and last participant exited the study 10/08/2010. |
|---|---|
| Pre-assignment Detail | 102 participants(204 eyes) were enrolled in this study. |
| Arm/Group Title | B & L Daily Disposable Lens, Then J & J Acuvue Moist | J & J Acuvue Moist, Then B & L Daily Disposable Lens |
|---|---|---|
| Arm/Group Description | Bausch & Lomb new daily disposable lenses are to be worn for approximately one week. Crossover to Johnson & Johnson Acuvue Moist lenses to be worn for approximately one week. Lenses will be worn on a daily wear basis. | Johnson & Johnson Acuvue Moist lenses are to be worn for approximately one week. Crossover to Bausch & Lomb new daily disposable lenses to be worn for approximately one week. Lenses will be worn on a daily wear basis. |
| Period Title: First Intervention (1 Week) | ||
| STARTED | 51 | 51 |
| COMPLETED | 49 | 50 |
| NOT COMPLETED | 2 | 1 |
| Period Title: First Intervention (1 Week) | ||
| STARTED | 49 | 50 |
| COMPLETED | 49 | 50 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Overall Study |
|---|---|
| Arm/Group Description | All eligible subjects |
| Overall Participants | 102 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
28.0
(7.8)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
71
69.6%
|
| Male |
31
30.4%
|
| Region of Enrollment (participants) [Number] | |
| United States |
102
100%
|
Outcome Measures
| Title | Visual Acuity |
|---|---|
| Description | Distance High contrast logMAR visual acuity (VA), difference between the test and control lens at dispensing visit and 1 week follow-up, crossover visit and 1 week follow-up. |
| Time Frame | Dispensing Visit and 1 week follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| All Eligible Dispensed Eyes |
| Arm/Group Title | Bausch & Lomb New Daily Disposable | Johnson & Johnson Acuvue Moist |
|---|---|---|
| Arm/Group Description | New daily disposable contact lenses Bausch & Lomb new daily disposable : Test lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis. | Contact lenses Johnson & Johnson Acuvue Moist : Control lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis. |
| Measure Participants | 99 | 99 |
| Measure eyes | 198 | 198 |
| Dispensing Visit |
-0.056
(0.079)
|
-0.070
(0.066)
|
| 1 Week Follow-up |
-0.063
(0.079)
|
-0.065
(0.079)
|
| Title | Slit Lamp Examination > Grade 2 |
|---|---|
| Description | Slit lamp findings for each eye will be assessed at each study visit, including epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates, will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Slit lamp > 2. |
| Time Frame | All study visits from screening through 2 week follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| All Dispensed Eyes |
| Arm/Group Title | Bausch & Lomb New Daily Disposable | Johnson & Johnson Acuvue Moist |
|---|---|---|
| Arm/Group Description | New daily disposable contact lenses Bausch & Lomb new daily disposable : Test lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis. | Contact lenses Johnson & Johnson Acuvue Moist : Control lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis. |
| Measure Participants | 99 | 99 |
| Measure eyes | 198 | 198 |
| Number [Eyes] |
0
|
0
|
Adverse Events
| Time Frame | 1 week | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Bausch & Lomb New Daily Disposable | Johnson & Johnson Acuvue Moist | ||
| Arm/Group Description | New daily disposable contact lenses Bausch & Lomb new daily disposable : Test lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis. | Contact lenses Johnson & Johnson Acuvue Moist : Control lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis. | ||
All Cause Mortality |
||||
| Bausch & Lomb New Daily Disposable | Johnson & Johnson Acuvue Moist | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Bausch & Lomb New Daily Disposable | Johnson & Johnson Acuvue Moist | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/102 (0%) | 0/102 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Bausch & Lomb New Daily Disposable | Johnson & Johnson Acuvue Moist | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/102 (0%) | 0/102 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Dr. Robert Steffen OD |
|---|---|
| Organization | Bausch & Lomb Incorporated |
| Phone | 585-338-6399 |
| robert.steffen@bausch.com |
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