A Study to Evaluate the Feasibility of a High Add Multi Focal Contact Lens
Study Details
Study Description
Brief Summary
The objective of this study is to evaluate the product performance of the investigational multifocal high add soft contact lens compared with PureVision Multi-focal contact lens on a daily wear basis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Investigational contact lens multifocal high add soft contact lens |
Device: Investigational contact lens
Worn on a daily wear basis for one week.
|
| Active Comparator: PureVision contact lens Multi-focal contact lens |
Device: PureVision contact lens
Worn on a daily wear basis for one week
|
Outcome Measures
Primary Outcome Measures
- Visual Acuity [At 2 weeks follow up]
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
Secondary Outcome Measures
- Symptoms/Complaints [At 2 weeks 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
-
Be adapted wearers of soft contact lenses and wear a lens in each eye.
-
Be presbyopic and require near add correction in each eye.
-
Be an adapted monovision or multifocal contact lens wearer or be an adapted spherical lens wearer who also uses spectacles for near vision correction.
-
Have no active ocular disease or allergic conjunctivitis.
-
Must not be using any topical ocular medications.
-
Must habitually use a lens care product for lens cleaning, disinfecting, and storage.
Exclusion Criteria:
-
Any Grade 2 or greater finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
-
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.
-
Allergic to any component in the study products.
-
Ocular astigmatism of greater than 1.00 D in either eye.
-
Have had any corneal surgery (ie, refractive surgery).
-
Uses AMO Ultra Care as their habitual lens care regimen.
-
Is a toric contact lens wearer.
-
Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months.
-
An active ocular disease (for example but not limited to papillary conjunctivitis, any conjunctivitis: viral, bacterial, allergic), any corneal infiltrative response or are using any ocular medications.
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.- 743E
Study Results
Participant Flow
| Recruitment Details | A total of 126 participants (252 eyes) were enrolled. One-half of the participants were randomized to receive the investigational contact lens during the first crossover period, and the other half were randomized to receive the PureVision contact lens during the first crossover period. The participants crossed over to the other group at 1 week. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Investigational Contact Lens Then PureVision Contact Lens | PureVision Contact Lens |
|---|---|---|
| Arm/Group Description | multifocal high add soft contact lens Investigational contact lens: Worn on a daily wear basis for one week. Multi-focal contact lens PureVision contact lens: Worn on a daily wear basis for one week | Multi-focal contact lens then Investigational Contact Lens PureVision contact lens: Worn on a daily wear basis for one week multifocal high add soft contact lens Investigational contact lens: Worn on a daily wear basis for one week. |
| Period Title: Overall Study | ||
| STARTED | 63 | 63 |
| COMPLETED | 59 | 59 |
| NOT COMPLETED | 4 | 4 |
Baseline Characteristics
| Arm/Group Title | Overall |
|---|---|
| Arm/Group Description | Participants received both treatment groups in this cross-over study. |
| Overall Participants | 124 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
51.6
(4.9)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
106
85.5%
|
| Male |
18
14.5%
|
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 2 weeks follow up |
Outcome Measure Data
| Analysis Population Description |
|---|
| There were 238 eyes assessed for visual acuity for this outcome measure. Participants/eyes received both treatment groups. |
| Arm/Group Title | Investigational Contact Lens | PureVision Contact Lens |
|---|---|---|
| Arm/Group Description | multifocal high add soft contact lens Investigational contact lens: Worn on a daily wear basis for one week. | Multi-focal contact lens PureVision contact lens: Worn on a daily wear basis for one week |
| Measure Participants | 119 | 119 |
| Measure eye | 238 | 238 |
| Mean (Standard Deviation) [logMAR] |
0.079
(0.102)
|
0.090
(0.091)
|
| Title | Symptoms/Complaints |
|---|---|
| Description | Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. |
| Time Frame | At 2 weeks follow up |
Outcome Measure Data
| Analysis Population Description |
|---|
| There were 238 eyes assessed for symptoms/complaints for this outcome measure. Participants/eyes received both treatment groups. |
| Arm/Group Title | Investigational Contact Lens | PureVision Contact Lens |
|---|---|---|
| Arm/Group Description | multifocal high add soft contact lens Investigational contact lens: Worn on a daily wear basis for one week. | Multi-focal contact lens PureVision contact lens: Worn on a daily wear basis for one week |
| Measure Participants | 119 | 119 |
| Measure eyes | 238 | 238 |
| Burning/stinging upon insertion |
95.6
(8.9)
|
92.5
(14.7)
|
| Comfort upon insertion |
89.4
(17.0)
|
81.5
(25.0)
|
| Comfort at end of day |
75.3
(25.4)
|
64.9
(28.8)
|
| Overall comfort |
81.6
(20.3)
|
70.5
(26.7)
|
| Dryness |
80.3
(20.3)
|
73.3
(26.4)
|
| Itchiness |
91.9
(13.8)
|
86.8
(22.1)
|
| Redness |
91.4
(14.4)
|
86.9
(23.0)
|
| Distance vision |
67.7
(29.8)
|
59.3
(30.8)
|
| Vision at intermediate distance |
80.5
(22.5)
|
70.3
(25.8)
|
| Vision at near distance |
65.0
(30.0)
|
58.8
(30.8)
|
| Overall vision |
66.7
(25.4)
|
56.2
(27.5)
|
| Ease of handling/insertion |
86.5
(20.4)
|
84.3
(21.7)
|
| Ease of handling/removal |
88.6
(16.3)
|
86.2
(19.6)
|
| Overall impression |
73.3
(23.5)
|
61.1
(29.9)
|
Adverse Events
| Time Frame | 2 weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse events (AEs) were not coded. Therefore, source vocabulary is not applicable. A total of 126 participants (262 eyes) were assessed for AEs. Participants/eyes received both treatment groups in this cross-over study. | |||
| Arm/Group Title | Investigational Contact Lens | PureVision Contact Lens | ||
| Arm/Group Description | multifocal high add soft contact lens Investigational contact lens: Worn on a daily wear basis by adapted monovision soft contact lens wearers for one week. Investigational contact lens: Worn on a daily wear basis by adapted multifocal soft contact wearers for one week. Investigational contact lens: Worn on a daily wear basis by adapted spherical soft contact lens wearers who may also use spectacles for near vision correction for one week | Multi-focal contact lens PureVision contact lens: Worn on a daily wear basis by adapted monovision soft contact lens wearers for one week PureVision contact lens: Worn on a daily wear basis by adapted multifocal soft contact wearers for one week. PureVision contact lens: Worn on a daily wear basis by adapted spherical soft contact lens wearers who may also use spectacles for near vision correction for one week | ||
All Cause Mortality |
||||
| Investigational Contact Lens | PureVision Contact Lens | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Investigational Contact Lens | PureVision Contact Lens | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/126 (0%) | 0/126 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Investigational Contact Lens | PureVision Contact Lens | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/126 (0%) | 0/126 (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 |
- 743E