Comparison of a Multifocal Contact Lens to a Traditional Multifocal Contact Lens
Study Details
Study Description
Brief Summary
The purpose of the trial is to compare the performance of two multifocal contact lens systems/products in established presbyopic subjects.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Other: Lotrafilcon B / Omafilcon A Lotrafilcon B, followed by Omafilcon A |
Device: Lotrafilcon B multifocal contact lens
Silicone hydrogel, soft, multifocal contact lens for daily wear use
Device: Omafilcon A multifocal contact lens
Hydrogel, soft, multifocal contact lens for daily wear use
|
Other: Omafilcon A / Lotrafilcon B Omafilcon A, followed by Lotrafilcon B |
Device: Lotrafilcon B multifocal contact lens
Silicone hydrogel, soft, multifocal contact lens for daily wear use
Device: Omafilcon A multifocal contact lens
Hydrogel, soft, multifocal contact lens for daily wear use
|
Outcome Measures
Primary Outcome Measures
- Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity [After 1 week of wear]
Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Be at least 35 years of age.
-
Best-corrected visual acuity of at least 20/40 in each eye.
-
Spectacle add from +1.50D and +2.50D (inclusive).
-
Able to be fit in available study sphere powers (Plano to -4.00D).
-
Currently wearing soft contact lenses at least 5 days a week.
-
Other protocol inclusion / exclusion criteria may apply.
Exclusion Criteria:
-
Requires concurrent ocular medication.
-
Eye injury or surgery within twelve weeks immediately prior to enrollment.
-
Currently enrolled in an ophthalmic clinical trial.
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Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
-
Previous refractive surgery.
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Astigmatism > 1.00D.
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Currently wearing Proclear Multifocal, Frequency 55 Multifocal or Biomedics EP contact lenses.
-
Other protocol inclusion / exclusion criteria may apply.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- CIBA VISION
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P-319-C-005 sub 8
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | Two participants were enrolled but not dispensed due to failing inclusion/exclusion criteria. These participants were included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations. |
Arm/Group Title | Lotrafilcon B / Omafilcon A | Omafilcon A / Lotrafilcon B |
---|---|---|
Arm/Group Description | Lotrafilcon B multifocal contact lens worn first, with Omafilcon A multifocal contact lens worn second. Both products worn in a daily wear basis. | Omafilcon A multifocal contact lens worn first, with Lotrafilcon B multifocal contact lens worn second. Both products worn in a daily wear basis. |
Period Title: Period 1 | ||
STARTED | 24 | 22 |
COMPLETED | 23 | 22 |
NOT COMPLETED | 1 | 0 |
Period Title: Period 1 | ||
STARTED | 23 | 22 |
COMPLETED | 23 | 22 |
NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Overall |
---|---|
Arm/Group Description | This reporting group includes all enrolled and dispensed subjects. |
Overall Participants | 46 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
49.3
(4.6)
|
Sex: Female, Male (Count of Participants) | |
Female |
37
80.4%
|
Male |
9
19.6%
|
Outcome Measures
Title | Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity |
---|---|
Description | Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity. |
Time Frame | After 1 week of wear |
Outcome Measure Data
Analysis Population Description |
---|
Per Protocol. Analysis excluded major protocol deviations as determined by masked review. |
Arm/Group Title | Lotrafilcon B | Omafilcon A |
---|---|---|
Arm/Group Description | Silicone hydrogel, soft, multifocal contact lens for daily wear use | Hydrogel, soft, multifocal contact lens for daily wear |
Measure Participants | 36 | 41 |
Mean (Standard Deviation) [logMAR] |
0.00
(0.07)
|
-0.02
(0.06)
|
Adverse Events
Time Frame | 7 weeks, the duration of the trial. | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Lotrafilcon B | Omafilcon A | ||
Arm/Group Description | Silicone hydrogel, soft, multifocal contact lens for daily wear | Hydrogel, soft, multifocal contact lens for daily wear | ||
All Cause Mortality |
||||
Lotrafilcon B | Omafilcon A | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Lotrafilcon B | Omafilcon A | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/46 (0%) | 0/45 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Lotrafilcon B | Omafilcon A | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/46 (0%) | 0/45 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any pre-clinical and/or clinical data or impressions from this trial.
Results Point of Contact
Name/Title | Priya Janakiraman, OD, FAAO / Head, Global Clinical Affairs |
---|---|
Organization | CIBA VISION |
Phone | 1-800-241-7629 |
priya.janakiraman@cibavision.com |
- P-319-C-005 sub 8