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Trial Outcomes & Findings for Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products (NCT NCT00909792)

NCT ID: NCT00909792

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

259 participants

Primary outcome timeframe

After 1 week of wear

Results posted on

2012-06-29

Participant Flow

One participant was enrolled but not dispensed due to failing inclusion/exclusion criteria. This participant is included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.

Participant milestones

Participant milestones
Measure
Lotrafilcon B / Senofilcon A
Lotrafilcon B multifocal contact lenses worn first, with Senofilcon A multifocal contact lenses worn second. Both products worn in a daily wear basis.
Senofilcon A / Lotrafilcon B
Senofilcon A multifocal contact lenses worn first, with Lotrafilcon B multifocal contact lenses worn second. Both products worn in a daily wear basis.
Period 1
STARTED
130
128
Period 1
COMPLETED
130
127
Period 1
NOT COMPLETED
0
1
Period 2
STARTED
129
125
Period 2
COMPLETED
128
124
Period 2
NOT COMPLETED
1
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Lotrafilcon B / Senofilcon A
Lotrafilcon B multifocal contact lenses worn first, with Senofilcon A multifocal contact lenses worn second. Both products worn in a daily wear basis.
Senofilcon A / Lotrafilcon B
Senofilcon A multifocal contact lenses worn first, with Lotrafilcon B multifocal contact lenses worn second. Both products worn in a daily wear basis.
Period 1
Did not meet inclusion criteria
0
1
Period 2
Biomicroscopy
1
0
Period 2
Lost to Follow-up
0
1

Baseline Characteristics

Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Overall
n=258 Participants
This reporting group includes all enrolled and dispensed subjects.
Age Continuous
45.5 Years
STANDARD_DEVIATION 4.3 • n=93 Participants
Sex: Female, Male
Female
222 Participants
n=93 Participants
Sex: Female, Male
Male
36 Participants
n=93 Participants

PRIMARY outcome

Timeframe: After 1 week of wear

Population: 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

Outcome measures
Measure
Lotrafilcon B Multifocal Contact Lens
n=237 Participants
Silicone hydrogel, soft, multifocal contact lens
Senofilcon A Multifocal Contact Lens
n=234 Participants
Silicone hydrogel, soft, multifocal contact lens
Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity
-0.01 logMAR
Standard Deviation 0.06
0.01 logMAR
Standard Deviation 0.07

Adverse Events

Lotrafilcon B

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Senofilcon A

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: 1-800-241-7629

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