A Study to Evaluate the Product Performance of a Low Add MultiFocal Soft Contact Lens
Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT01539694
Collaborator
(none)
126
1
2
2
63.9
Study Details
Study Description
Brief Summary
The objective of this study is to evaluate the product performance of an investigational multifocal low add soft contact lens.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
126 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Screening
Official Title:
A Study to Evaluate the Product Performance of a Low Add MultiFocal Soft Contact Lens
Study Start Date
:
Jan 1, 2012
Actual Primary Completion Date
:
Feb 1, 2012
Actual Study Completion Date
:
Mar 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LD118033 contact lens Investigational LD118033 multifocal low add soft contact lenses, to be worn on a daily wear basis. |
Device: LD118033 contact lens
Multifocal contact lens worn on a daily wear basis for 1 week
|
| Active Comparator: PureVision multifocal contact lens PureVision multifocal low add soft contact lens, to be worn on a daily wear basis. |
Device: PureVision multifocal contact lens
PureVision multifocal contact lens worn on a daily wear basis for 1 week.
|
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/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
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
-
Have no active ocular disease or allergic conjunctivitis.
-
Must not be using any topical ocular medications.
Exclusion Criteria:
-
Any Grade 2 or greater finding during the slit lamp examination.
-
Any scar or neovascularization within the central 4mm of the cornea.
-
Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
-
Allergic to any component in the study products.
-
Any systemic disease affecting ocular health.
-
Using any systemic or topical medications that will affect ocular physiology or lens performance.
-
An active ocular disease, 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: Gerard Cairns, PhD, MCOptom, Bausch & Lomb Incorporated
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01539694
Other Study ID Numbers:
- 744E
First Posted:
Feb 27, 2012
Last Update Posted:
Sep 30, 2020
Last Verified:
Sep 1, 2020
Additional relevant MeSH terms:
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 | LD118033 Contact Lens Then PureVision Multifocal Contact Lens | PureVision Multifocal Contact Lens Then LD118033 Contact Lens |
|---|---|---|
| Arm/Group Description | Investigational LD118033 multifocal low add soft contact lenses, to be worn on a daily wear basis. LD118033 contact lens: Multifocal contact lens worn on a daily wear basis for 1 week PureVision multifocal low add soft contact lens, to be worn on a daily wear basis. PureVision multifocal contact lens: PureVision multifocal contact lens worn on a daily wear basis for 1 week | PureVision multifocal low add soft contact lens, to be worn on a daily wear basis. PureVision multifocal contact lens: PureVision multifocal contact lens worn on a daily wear basis for 1 week. Investigational LD118033 multifocal low add soft contact lenses, to be worn on a daily wear basis. LD118033 contact lens: Multifocal contact lens worn on a daily wear basis for 1 week |
| Period Title: Overall Study | ||
| STARTED | 63 | 63 |
| COMPLETED | 62 | 62 |
| NOT COMPLETED | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | Overall |
|---|---|
| Arm/Group Description | All participants/eyes received both treatment groups. |
| Overall Participants | 124 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
47.0
(4.7)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
93
75%
|
| Male |
31
25%
|
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 124 eligible, dispensed participants (248 eyes). Participants/eyes received both treatment groups. |
| Arm/Group Title | LD118033 Contact Lens | PureVision Multifocal Contact Lens |
|---|---|---|
| Arm/Group Description | Investigational LD118033 multifocal low add soft contact lenses, to be worn on a daily wear basis. LD118033 contact lens: Multifocal contact lens worn on a daily wear basis for 1 week | PureVision multifocal low add soft contact lens, to be worn on a daily wear basis. PureVision multifocal contact lens: PureVision multifocal contact lens worn on a daily wear basis for 1 week. |
| Measure Participants | 124 | 124 |
| Measure eyes | 248 | 248 |
| Mean (Standard Deviation) [logMAR] |
0.023
(0.078)
|
0.005
(0.069)
|
| 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 |
|---|
| There were 124 eligible, dispensed participants (248 eyes). Participants/eyes received both treatment groups. |
| Arm/Group Title | LD118033 Contact Lens | PureVision Multifocal Contact Lens |
|---|---|---|
| Arm/Group Description | Investigational LD118033 multifocal low add soft contact lenses, to be worn on a daily wear basis. LD118033 contact lens: Multifocal contact lens worn on a daily wear basis for 1 week | PureVision multifocal low add soft contact lens, to be worn on a daily wear basis. PureVision multifocal contact lens: PureVision multifocal contact lens worn on a daily wear basis for 1 week. |
| Measure Participants | 124 | 124 |
| Measure eyes | 248 | 248 |
| Burning/stinging upon insertion |
91.3
(12.6)
|
89.2
(16.9)
|
| Comfort upon insertion |
87.0
(16.6)
|
83.9
(18.0)
|
| Comfort at end of day |
72.5
(24.4)
|
68.1
(25.0)
|
| Overall comfort |
79.2
(21.2)
|
74.6
(22.9)
|
| Dryness |
78.7
(22.4)
|
75.2
(23.7)
|
| Itchiness |
89.1
(17.0)
|
84.5
(21.1)
|
| Redness |
91.9
(12.3)
|
87.0
(18.0)
|
| Distance Vision |
69.3
(30.4)
|
76.5
(23.3)
|
| Vision at intermediate distance |
81.2
(20.3)
|
80.7
(18.3)
|
| Vision at near distance |
76.3
(25.7)
|
72.2
(26.2)
|
| Overall vision |
72.9
(25.8)
|
73.7
(22.7)
|
| Ease of handling/insertion |
85.7
(18.8)
|
85.4
(19.7)
|
| Ease of handling/removal |
88.5
(17.2)
|
87.5
(17.5)
|
| Overall impression |
24.7
(24.0)
|
74.6
(22.7)
|
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 (252 eyes) were assessed for AEs. Participants/eyes received both treatment groups in this cross-over study. | |||
| Arm/Group Title | LD118033 Contact Lens | PureVision Multifocal Contact Lens | ||
| Arm/Group Description | Investigational LD118033 multifocal low add soft contact lenses, to be worn on a daily wear basis. LD118033 contact lens: Multifocal contact lens worn on a daily wear basis for 1 week | PureVision multifocal low add soft contact lens, to be worn on a daily wear basis. PureVision multifocal contact lens: PureVision multifocal contact lens worn on a daily wear basis for 1 week. | ||
All Cause Mortality |
||||
| LD118033 Contact Lens | PureVision Multifocal Contact Lens | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| LD118033 Contact Lens | PureVision Multifocal Contact Lens | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/126 (0%) | 0/126 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| LD118033 Contact Lens | PureVision Multifocal Contact Lens | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/126 (0%) | 0/126 (0%) | ||
Limitations/Caveats
[Not Specified]
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 |
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01539694
Other Study ID Numbers:
- 744E
First Posted:
Feb 27, 2012
Last Update Posted:
Sep 30, 2020
Last Verified:
Sep 1, 2020