A Study to Evaluate the Product Feasibility of Two New Silicone Hydrogel Contact Lenses
Study Details
Study Description
Brief Summary
The objective of this study is to determine the clinical feasibility and to evaluate the product performance of two RD2135-01 investigational soft contact lenses (Test 1 and Test 2) developed by Bausch + Lomb. The Test lenses will be compared to both Bausch + Lomb PureVision®2 HD (high definition) soft contact lenses and Ciba Vision Air Optix Aqua soft contact lenses when used among currently adapted soft contact lens wearers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: B&L RD2135-01 lens C Investigational Silicone hydrogel soft contact lens |
Device: B&L RD2135-01 lens C
Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.
|
| Experimental: B&L RD2135-01 lens D Investigational Silicone hydrogel soft contact lens |
Device: B&L RD2135-01 lens D
Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.
|
| Active Comparator: PureVision2 Bausch & Lomb High definition soft contact lenses |
Device: PureVision2
Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.
|
| Active Comparator: Ciba Vision Air Optix Aqua Ciba Vision Air Optix Aqua soft contact lens |
Device: Air Optix Aqua
Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.
|
Outcome Measures
Primary Outcome Measures
- Visual Acuity [At 1 week 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 1 Week follow up]
Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. Symptoms/complaints were recorded for each eye based on the participant's experience with their study lenses worn for that respective treatment period. 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, Lens cleanness, Dryness at end of day, and Overall impression.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
-
Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
-
Be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
-
Be myopic and require lens correction from -0.50 diopters (D) to -6.00 D in each eye.
-
Must agree to wear the study lenses on a daily wear basis for the duration of the study.
-
Must be willing to use a lens care system on a regular basis.
-
If the subject requires a Washout Period, the subject must be willing to discontinue contact lens wear and be willing to wear either spectacles or no lenses during this Washout Period.
Exclusion Criteria:
-
Not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.
-
Have an active ocular disease, any corneal infiltrative response or are using any ocular medications.
-
Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months.
-
Any scar or neovascularization within the central 4mm of the cornea.
-
Any Grade 2 or greater finding during the slit lamp examination, Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
-
Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
-
Anisometropia (spherical equivalent) of greater than 2.00 D.
-
Any systemic disease affecting ocular health.
-
Using any systemic or topical medications that will affect ocular physiology or lens performance.
-
Aphakic.
-
Amblyopic.
-
Allergic to any component in the study products.
-
Have had any corneal surgery (ie, refractive surgery).
-
Currently wear monovision correction, multifocal, or toric contact lenses.
-
Ocular astigmatism greater than 1.00 D in either eye.
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.- 755E
Study Results
Participant Flow
| Recruitment Details | This was a randomized, bilateral, study, with a crossover at one week and a second crossover at two weeks. A total of 216 subjects (432 eyes) were enrolled in this study. Participants were randomized to receive either, the Test Lens C, Test Lens D and PureVision2 lenses, or the Test Lens C, Test Lens D and Air Optix Aqua lenses. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | B&L RD2135-01 Lens C Then B&L RD2135-01 Lens D Then PureVision | B&L RD2135-01 Lens C Then B&L RD2135-01 Lens D Then Ciba Vis |
|---|---|---|
| Arm/Group Description | B&L RD2135-01 Lens C for one week then B&L RD2135-01 Lens D for one week then PureVision2 for one week | B&L RD2135-01 Lens C for one week then B&L RD2135-01 Lens D for one week then Ciba Vision for one week |
| Period Title: Overall Study | ||
| STARTED | 108 | 108 |
| COMPLETED | 104 | 104 |
| NOT COMPLETED | 4 | 4 |
Baseline Characteristics
| Arm/Group Title | B&L RD2135-01 Lens C Then B&L RD2135-01 Lens D Then PureVision | B&L RD2135-01 Lens C Then B&L RD2135-01 Lens D Then Ciba Vis | Total |
|---|---|---|---|
| Arm/Group Description | B&L RD2135-01 Lens C for one week then B&L RD2135-01 Lens D for one week then PureVision2 for one week | B&L RD2135-01 Lens C for one week then B&L RD2135-01 Lens D for one week then Ciba Vision for one week | Total of all reporting groups |
| Overall Participants | 105 | 105 | 210 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
31.3
(8.55)
|
31.8
(8.68)
|
31.5
(8.60)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
72
68.6%
|
71
67.6%
|
143
68.1%
|
| Male |
33
31.4%
|
34
32.4%
|
67
31.9%
|
Outcome Measures
| Title | Visual Acuity |
|---|---|
| Description | Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR). |
| Time Frame | At 1 week follow up |
Outcome Measure Data
| Analysis Population Description |
|---|
| There were 212 eligible, dispensed participants (424 eyes). Participants/eyes received multiple treatment groups in this cross-over study. All eyes received investigational lens C and investigation lens D. Half of the eyes received PureVision2 and half of the eyes received Ciba Vision Air Optix Aqua. |
| Arm/Group Title | B&L RD2135-01 Lens C | B&L RD2135-01 Lens D | PureVision2 | Ciba Vision Air Optix Aqua |
|---|---|---|---|---|
| Arm/Group Description | Investigational Silicone hydrogel soft contact lens B&L RD2135-01 lens C: Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study. | Investigational Silicone hydrogel soft contact lens B&L RD2135-01 lens D: Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study. | Bausch & Lomb High definition soft contact lenses PureVision2: Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study. | Ciba Vision Air Optix Aqua soft contact lens Air Optix Aqua: Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study. |
| Measure Participants | 212 | 212 | 106 | 106 |
| Measure eyes | 424 | 424 | 212 | 212 |
| Mean (Standard Deviation) [logMAR] |
-0.089
(0.078)
|
-0.087
(0.079)
|
-0.086
(0.077)
|
-0.086
(0.082)
|
| 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 for each eye based on the participant's experience with their study lenses worn for that respective treatment period. 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, Lens cleanness, Dryness at end of day, and Overall impression. |
| Time Frame | At 1 Week follow up |
Outcome Measure Data
| Analysis Population Description |
|---|
| There were 212 eligible, dispensed participants (424 eyes). Participants/eyes received multiple treatment groups in this cross-over study. All eyes received investigational lens C and investigation lens D. Half of the eyes received PureVision2 and half of the eyes received Ciba Vision Air Optix Aqua. |
| Arm/Group Title | B&L RD2135-01 Lens C | B&L RD2135-01 Lens D | PureVision2 | Ciba Vision Air Optix Aqua |
|---|---|---|---|---|
| Arm/Group Description | Investigational Silicone hydrogel soft contact lens B&L RD2135-01 lens C: Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study. | Investigational Silicone hydrogel soft contact lens B&L RD2135-01 lens D: Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study. | Bausch & Lomb High definition soft contact lenses PureVision2: Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study. | Ciba Vision Air Optix Aqua soft contact lens Air Optix Aqua: Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study. |
| Measure Participants | 212 | 212 | 106 | 106 |
| Measure eyes | 424 | 424 | 212 | 212 |
| Burning/stinging upon insertion |
91.3
(13.1)
|
91.3
(12.4)
|
83.1
(21.4)
|
92.6
(9.9)
|
| Comfort upon insertion |
89.6
(14.5)
|
88.2
(15.6)
|
78.7
(15.6)
|
89.6
(12.0)
|
| Overall comfort |
88.0
(14.6)
|
85.7
(16.9)
|
78.4
(20.4)
|
86.6
(15.8)
|
| Comfort at end of day |
81.2
(18.9)
|
79.3
(20.2)
|
72.0
(22.9)
|
79.7
(19.7)
|
| Ease of handling/insertion |
89.5
(16.6)
|
88.6
(17.3)
|
85.0
(20.4)
|
89.0
(15.3)
|
| Ease of handling/removal |
91.1
(14.3)
|
91.0
(13.6)
|
89.4
(15.6)
|
89.4
(15.5)
|
| Dryness |
84.4
(16.1)
|
81.9
(18.1)
|
77.0
(21.6)
|
84.4
(17.3)
|
| Itchiness |
90.6
(12.9)
|
89.6
(15.9)
|
87.4
(17.0)
|
88.5
(17.3)
|
| Redness |
92.4
(11.7)
|
91.6
(13.1)
|
90.6
(14.0)
|
91.2
(12.5)
|
| Vision upon insertion |
93.4
(9.6)
|
91.5
(13.3)
|
87.0
(17.5)
|
93.1
(9.6)
|
| Vision |
92.3
(11.4)
|
91.9
(13.1)
|
88.1
(14.6)
|
93.5
(10.3)
|
| Vision in low light |
91.0
(11.9)
|
89.9
(13.4)
|
87.3
(13.8)
|
91.4
(12.5)
|
| Lens cleanness upon insertion |
93.1
(10.9)
|
92.8
(11.4)
|
89.7
(14.6)
|
94.4
(7.7)
|
| Lens cleannes upon removal |
89.9
(12.2)
|
89.3
(12.9)
|
86.3
(17.2)
|
90.9
(9.7)
|
| Lens cleanness |
91.8
(10.6)
|
91.2
(11.7)
|
86.6
(17.0)
|
92.5
(9.1)
|
| Dryness at end of day |
82.4
(17.7)
|
80.3
(19.3)
|
75.5
(21.7)
|
82.4
(17.3)
|
| Overall impression |
84.5
(17.0)
|
82.2
(19.0)
|
73.7
(24.6)
|
83.9
(18.3)
|
Adverse Events
| Time Frame | 3 weeks | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse events (AEs) were not coded. Therefore, source vocabulary is not applicable. Safety data were collected for 212 eligible, dispensed participants. Participants received multiple treatment groups in this cross-over study. | |||||||
| Arm/Group Title | B&L RD2135-01 Lens C | B&L RD2135-01 Lens D | PureVision2 | Ciba Vision Air Optix Aqua | ||||
| Arm/Group Description | B&L RD2135-01 Lens C | B&L RD2135-01 Lens D | PureVision2 | Ciba Vision Air Optix Aqua | ||||
All Cause Mortality |
||||||||
| B&L RD2135-01 Lens C | B&L RD2135-01 Lens D | PureVision2 | Ciba Vision Air Optix Aqua | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| B&L RD2135-01 Lens C | B&L RD2135-01 Lens D | PureVision2 | Ciba Vision Air Optix Aqua | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/212 (0%) | 0/212 (0%) | 0/106 (0%) | 0/106 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| B&L RD2135-01 Lens C | B&L RD2135-01 Lens D | PureVision2 | Ciba Vision Air Optix Aqua | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/212 (0%) | 0/212 (0%) | 0/106 (0%) | 0/106 (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 |
- 755E