A Study to Evaluate the Performance of Two Designs of Soft Toric Lenses
Study Details
Study Description
Brief Summary
The objective of the study is to evaluate the product performance of the Bausch + Lomb toric investigational contact lenses compared to the currently marketed PureVision toric contact lenses.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Investigational Toric Lens Bausch + Lomb investigational toric contact lenses |
Device: Investigational Toric Lens
Bausch & Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks.
|
| Active Comparator: PureVision Toric Lens Currently marketed Bausch + Lomb PureVision toric contact lenses |
Device: PureVision Toric Lens
Currently marked Bausch & Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Eyes With Absolute Lens Rotation ≤ 10 Degrees. [2 weeks]
- Visual Acuity [2 weeks]
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
Secondary Outcome Measures
- Symptoms and Complaints [2 weeks]
Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. Symptoms/complaints were recorded at each post-dispensing visit based on the subject's experience with the study lens worn prior to the visit. The symptoms/complaints parameters were: Burning/stinging upon insertion; Comfort upon insertion, Overall comfort, and Comfort at the end of the day; Ease of handling/insertion, and Ease of handling/removal; Dryness; Itchiness; Redness; Vision; Lens cleanliness; and Overall impression.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subjects must have clear central corneas and be free of any anterior segment disorders.
-
Subjects must be adapted lens wearers, wear a lens in each eye and each lens must be of the same manufacture and brand.
-
Subjects must be myopic and require lens correction
-
Subjects must be habitual wearers of toric soft contact lenses.
Exclusion Criteria:
-
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 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 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: Beverly Barna, Bausch & Lomb Incorporated
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 680
Study Results
Participant Flow
| Recruitment Details | A total of 151 participants (302 eyes) were randomized to receive test contact lenses and 151 participants (302 eyes) were randomized to receive control contact lenses. After two weeks of wearing the first lens type, the participants crossed over to the second lens type for two weeks. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Investigational Toric Lens Then PureVision Toric Lens | PureVision Toric Lens Then Investigational Toric Lens |
|---|---|---|
| Arm/Group Description | Bausch + Lomb investigational toric contact lenses Investigational Toric Lens: Bausch & Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks. Currently marketed Bausch + Lomb PureVision toric contact lenses PureVision Toric Lens: Currently marked Bausch & Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks. | Currently marketed Bausch + Lomb PureVision toric contact lenses PureVision Toric Lens: Currently marked Bausch & Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks. Bausch + Lomb investigational toric contact lenses Investigational Toric Lens: Bausch & Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks. |
| Period Title: Overall Study | ||
| STARTED | 151 | 151 |
| COMPLETED | 148 | 139 |
| NOT COMPLETED | 3 | 12 |
Baseline Characteristics
| Arm/Group Title | All Participants |
|---|---|
| Arm/Group Description | Participants were randomized 1:1 to receive test contact lenses or control contact lenses. After two weeks of wearing the first lens type, the participants crossed over to the second lens type for two weeks. |
| Overall Participants | 302 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
34.9
(11.1)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
208
68.9%
|
| Male |
94
31.1%
|
Outcome Measures
| Title | Percentage of Eyes With Absolute Lens Rotation ≤ 10 Degrees. |
|---|---|
| Description | |
| Time Frame | 2 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| There were 518 eyes in each group for this outcome measure. |
| Arm/Group Title | Investigational Toric Lens | PureVision Toric Lens |
|---|---|---|
| Arm/Group Description | Bausch + Lomb investigational toric contact lenses Investigational Toric Lens: Bausch & Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks. | Currently marketed Bausch + Lomb PureVision toric contact lenses PureVision Toric Lens: Currently marked Bausch & Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks. |
| Measure Participants | 259 | 259 |
| Measure eyes | 518 | 518 |
| Count of Units [eyes] |
489
|
426
|
| Title | Visual Acuity |
|---|---|
| Description | Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR). |
| Time Frame | 2 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| There were 518 eyes in each group for this outcome measure. |
| Arm/Group Title | Investigational Toric Lens | PureVision Toric Lens |
|---|---|---|
| Arm/Group Description | Bausch + Lomb investigational toric contact lenses Investigational Toric Lens: Bausch & Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks. | Currently marketed Bausch + Lomb PureVision toric contact lenses PureVision Toric Lens: Currently marked Bausch & Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks. |
| Measure Participants | 259 | 259 |
| Measure eyes | 518 | 518 |
| Least Squares Mean (Standard Deviation) [logMAR] |
-0.025
(0.106)
|
-0.021
(0.106)
|
| Title | Symptoms and Complaints |
|---|---|
| Description | Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. Symptoms/complaints were recorded at each post-dispensing visit based on the subject's experience with the study lens worn prior to the visit. The symptoms/complaints parameters were: Burning/stinging upon insertion; Comfort upon insertion, Overall comfort, and Comfort at the end of the day; Ease of handling/insertion, and Ease of handling/removal; Dryness; Itchiness; Redness; Vision; Lens cleanliness; and Overall impression. |
| Time Frame | 2 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| There were 571 eyes in each group assess for this outcome measure. |
| Arm/Group Title | Investigational Toric Lens | PureVision Toric Lens |
|---|---|---|
| Arm/Group Description | Bausch + Lomb investigational toric contact lenses Investigational Toric Lens: Bausch & Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks. | Currently marketed Bausch + Lomb PureVision toric contact lenses PureVision Toric Lens: Currently marked Bausch & Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks. |
| Measure Participants | 286 | 286 |
| Measure eyes | 571 | 571 |
| Burning/stinging upon insertion |
85.4
(28.1)
|
82.0
(28.1)
|
| Comfort upon insertion |
77.7
(29.4)
|
74.3
(29.4)
|
| Overall comfort |
77.3
(29.6)
|
67.9
(29.6)
|
| Comfort at the end of the day |
67.8
(33.6)
|
57.6
(33.6)
|
| Ease of handling/insertion |
84.4
(25.2)
|
80.9
(25.2)
|
| Ease of handling/removal |
87.6
(23.0)
|
83.7
(23.0)
|
| Dryness |
73.6
(32.1)
|
66.3
(32.1)
|
| Itchiness |
86.6
(26.0)
|
82.0
(26.0)
|
| Redness |
88.0
(23.9)
|
83.5
(23.9)
|
| Vision |
82.0
(28.3)
|
73.9
(28.3)
|
| Lens Cleanliness |
86.1
(22.1)
|
83.5
(22.1)
|
| Overall impression |
74.4
(30.3)
|
64.2
(30.3)
|
| 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 600 eyes with non-missing scores in both groups for this outcome measure. |
| Arm/Group Title | Investigational Toric Lens | PureVision Toric Lens |
|---|---|---|
| Arm/Group Description | Bausch + Lomb investigational toric contact lenses Investigational Toric Lens: Bausch & Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks. | Currently marketed Bausch + Lomb PureVision toric contact lenses PureVision Toric Lens: Currently marked Bausch & Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks. |
| Measure Participants | 300 | 300 |
| Measure eyes | 600 | 600 |
| Count of Units [eyes] |
1
|
1
|
Adverse Events
| Time Frame | 4 weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse events were not coded. Therefore, source vocabulary is not applicable. There were 302 eyes dispensed each lens group, assessed for adverse events. | |||
| Arm/Group Title | Investigational Toric Lens | PureVision Toric Lens | ||
| Arm/Group Description | Bausch + Lomb investigational toric contact lenses Investigational Toric Lens: Bausch & Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks. | Currently marketed Bausch + Lomb PureVision toric contact lenses PureVision Toric Lens: Currently marked Bausch & Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks. | ||
All Cause Mortality |
||||
| Investigational Toric Lens | PureVision Toric Lens | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Investigational Toric Lens | PureVision Toric Lens | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/151 (0%) | 0/151 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Investigational Toric Lens | PureVision Toric Lens | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/151 (0%) | 0/151 (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 | 585-338-6399 |
| robert.steffen@bausch.com |
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