Trial Outcomes & Findings for Comparison of a Multifocal Contact Lens to a Traditional Multifocal Contact Lens (NCT NCT00886119)
NCT ID: NCT00886119
Last Updated: 2012-06-29
Results Overview
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.
COMPLETED
NA
48 participants
After 1 week of wear
2012-06-29
Participant Flow
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.
Participant milestones
| Measure |
Lotrafilcon B / Omafilcon A
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 / Lotrafilcon B
Omafilcon A multifocal contact lens worn first, with Lotrafilcon B multifocal contact lens worn second. Both products worn in a daily wear basis.
|
|---|---|---|
|
Period 1
STARTED
|
24
|
22
|
|
Period 1
COMPLETED
|
23
|
22
|
|
Period 1
NOT COMPLETED
|
1
|
0
|
|
Period 2
STARTED
|
23
|
22
|
|
Period 2
COMPLETED
|
23
|
22
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Lotrafilcon B / Omafilcon A
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 / Lotrafilcon B
Omafilcon A multifocal contact lens worn first, with Lotrafilcon B multifocal contact lens worn second. Both products worn in a daily wear basis.
|
|---|---|---|
|
Period 1
Did not meet inclusion criteria
|
1
|
0
|
Baseline Characteristics
Comparison of a Multifocal Contact Lens to a Traditional Multifocal Contact Lens
Baseline characteristics by cohort
| Measure |
Overall
n=46 Participants
This reporting group includes all enrolled and dispensed subjects.
|
|---|---|
|
Age Continuous
|
49.3 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After 1 week of wearPopulation: Per Protocol. Analysis excluded major protocol deviations as determined by masked review.
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.
Outcome measures
| Measure |
Lotrafilcon B
n=36 Participants
Silicone hydrogel, soft, multifocal contact lens for daily wear use
|
Omafilcon A
n=41 Participants
Hydrogel, soft, multifocal contact lens for daily wear
|
|---|---|---|
|
Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity
|
0.00 logMAR
Standard Deviation 0.07
|
-0.02 logMAR
Standard Deviation 0.06
|
Adverse Events
Lotrafilcon B
Omafilcon A
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Priya Janakiraman, OD, FAAO / Head, Global Clinical Affairs
CIBA VISION
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER