A Study to Evaluate a Mid Add Multi-Focal Soft Contact Lens
Study Details
Study Description
Brief Summary
This study is to evaluate the product performance of the investigational LD127025 MF mid add soft contact lens compared to CIBA Vision's Air Optix Aqua MF MED add 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: LD127025 MF Mid add daily disposable soft contact lens worn on a daily wear basis for 1 week. |
Device: LD127025 MF
At Visit 1, one-half of the subjects will be randomized to receive the investigational soft contact lens, after approximately one week of wearing the first lens type, the subjects will return for the 1-Week Crossover Visit (Visit 2) for an exam, and to determine if the subject remains eligible to continue in the next phase of the study with the control soft contact lens.
Device: Air Optix Aqua MF
At Visit 1, one-half of the subjects will be randomized to receive the control soft contact lens, after approximately one week of wearing the first lens type, the subjects will return for the 1-Week Crossover Visit (Visit 2) for an exam, and to determine if the subject remains eligible to continue in the next phase of the study with the investigational soft contact lens.
|
| Active Comparator: Air Optix Aqua MF Medium add daily disposable soft contact lens worn on a daily wear basis for one week. |
Device: LD127025 MF
At Visit 1, one-half of the subjects will be randomized to receive the investigational soft contact lens, after approximately one week of wearing the first lens type, the subjects will return for the 1-Week Crossover Visit (Visit 2) for an exam, and to determine if the subject remains eligible to continue in the next phase of the study with the control soft contact lens.
Device: Air Optix Aqua MF
At Visit 1, one-half of the subjects will be randomized to receive the control soft contact lens, after approximately one week of wearing the first lens type, the subjects will return for the 1-Week Crossover Visit (Visit 2) for an exam, and to determine if the subject remains eligible to continue in the next phase of the study with the investigational soft contact lens.
|
Outcome Measures
Primary Outcome Measures
- Mean 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/Complaints [At 1 Week follow up]
Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.
Eligibility Criteria
Criteria
Inclusion Criteria
-
Have physiologically normal anterior segments not exhibiting biomicroscopy findings Grade 2 or greater and/or presence of infiltrates.
-
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 42 letters (0.1 logMAR) or better (distance, high contrast) in each eye.
-
Require contact lens correction from -5.00 D to +3.00 D in each eye.
-
Be Presbyopic and require near add correction from +1.00 D to +1.75 D in each eye.
-
Be an adapted monovision soft contact lens wearer or multifocal soft contact lens wearer or an adapted spherical soft contact lens wearer who also uses spectacles for near vision correction.
-
Be willing to use a lens care system as required by the lens replacement schedule.
-
Has a distance spherical equivalent refraction between -5.50 D and +3.00 D.
Exclusion Criteria:
-
Not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.
-
Participated in any drug or device clinical investigation (within 14 days) prior to entry into this study and/or during the period of study participation.
-
Women of childbearing potential if one of the following: pregnant, plans to become pregnant during study, is breast-feeding.
-
Any Grade 2 or greater finding during the slit lamp examination. Subjects with corneal infiltrates of ANY GRADE are not eligible.
-
Any scar or neovascularization within the central 4mm 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.
-
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.
-
Aphakic.
-
Amblyopic.
-
Allergic to any component in the study care products.
-
Meet any of the following criteria:
-
Ophthalmologist, OD, Optician, Ophthalmologist's Assistant/Technician
-
employee of a market research firm
-
employee of manufacturer of contact lens or contact lens care products
-
Ocular astigmatism of greater than 1.00 D in either eye.
-
Have had any corneal surgery (ie, refractive surgery).
-
Toric contact lens wearer.
-
Have worn gas permeable (GP) contact lenses within the last 30 days or PMMA lenses within the last 3 months.
-
Have an active ocular disease or are using any ocular medication.
-
Have 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.
-
Using any systemic medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
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: Robert Stefffen, Bausch & Lomb Incorporated
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 825E
Study Results
Participant Flow
| Recruitment Details | There were 146 participants (292 eyes) were enrolled in this study. One-half of the participants were randomized to receive the investigational lens, and the other half to the control lens. After one week, the participant crossed over to the second lens type for one week. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | LD127025 MF Then Air Optix Aqua MF | Air Optix Aqua MF Then LD127025 MF |
|---|---|---|
| Arm/Group Description | LD127025 MF and then Air Optix Aqua MF after 1 week | Air Optix Aqua MF and then LD127025 MF after 1 week |
| Period Title: Overall Study | ||
| STARTED | 73 | 73 |
| COMPLETED | 71 | 71 |
| NOT COMPLETED | 2 | 2 |
Baseline Characteristics
| Arm/Group Title | Overall Enrolled |
|---|---|
| Arm/Group Description | Overall participants enrolled. |
| Overall Participants | 145 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
48.2
(5.3)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
110
75.9%
|
| Male |
35
24.1%
|
Outcome Measures
| Title | Mean 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 |
|---|
| Eligible, dispensed eyes assessed for visual acuity are included in the analysis population. |
| Arm/Group Title | LD127025 MF | Air Optix Aqua MF |
|---|---|---|
| Arm/Group Description | Mid add daily disposable soft contact lens worn on a daily wear basis for 1 week. | Medium add daily disposable soft contact lens worn on a daily wear basis for one week. |
| Measure Participants | 143 | 144 |
| Measure eyes | 286 | 288 |
| Least Squares Mean (Standard Deviation) [logMAR] |
-0.026
(0.070)
|
0.008
(0.078)
|
| Title | Symptoms/Complaints |
|---|---|
| Description | Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. |
| Time Frame | At 1 Week follow up |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eligible, dispensed eyes assessed for symptoms/complaints are included in the analysis population. |
| Arm/Group Title | LD127025 MF | Air Optix Aqua MF |
|---|---|---|
| Arm/Group Description | Mid add daily disposable soft contact lens worn on a daily wear basis for 1 week. | Medium add daily disposable soft contact lens worn on a daily wear basis for one week. |
| Measure Participants | 143 | 141 |
| Measure eyes | 286 | 282 |
| Burning/stinging upon insertion |
96.1
(9.8)
|
93.4
(11.8)
|
| Comfort upon insertion |
95.4
(8.3)
|
91.4
(12.6)
|
| Comfort at end of day |
83.7
(19.5)
|
79.9
(20.7)
|
| Overall comfort |
88.3
(16.4)
|
84.6
(17.4)
|
| Ease of handling/insertion |
92.3
(13.3)
|
93.5
(9.6)
|
| Ease of handling/removal |
89.3
(16.5)
|
93.6
(9.7)
|
| Dryness |
86.1
(18.2)
|
85.6
(16.9)
|
| Itchiness |
94.4
(10.3)
|
90.2
(15.1)
|
| Redness |
95.3
(7.6)
|
91.0
(13.9)
|
| Overall impression |
84.1
(19.7)
|
83.3
(19.9)
|
| Distance vision |
91.0
(16.1)
|
82.0
(21.1)
|
| Vision at intermediate distance |
80.8
(21.8)
|
84.4
(16.3)
|
| Vision at near distance |
60.1
(28.6)
|
76.1
(22.6)
|
| Overall vision |
74.0
(23.0)
|
79.5
(19.9)
|
Adverse Events
| Time Frame | 2 weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse events were not coded. Therefore, source vocabulary is not applicable. Safety data were reported for all eligible, dispensed participants. There was one participant that was not eligible for the study, and thus was excluded. | |||
| Arm/Group Title | LD127025 MF | Air Optix Aqua MF | ||
| Arm/Group Description | Mid add daily disposable soft contact lens worn on a daily wear basis for 1 week. | Medium add daily disposable soft contact lens worn on a daily wear basis for one week. | ||
All Cause Mortality |
||||
| LD127025 MF | Air Optix Aqua MF | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| LD127025 MF | Air Optix Aqua MF | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/145 (0%) | 0/145 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| LD127025 MF | Air Optix Aqua MF | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/145 (0%) | 0/145 (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 |
- 825E