Trial Outcomes & Findings for Subjective Evaluation of a Commercially Marketed Contact Lens Amongst a Subset of the Contact Lens Wearing Population (NCT NCT01007916)

Results Overview

Comfort upon insertion, as interpreted by the participant, was recorded on a questionnaire by the participant using a 10-point scale, with 1 being poor and 10 being excellent. Comfort upon insertion was assessed as a single, retrospective evaluation of 4-weeks' wear time.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

4 weeks of wear

Results posted on

2012-07-10

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 / Habitual Lotrafilcon B contact lenses worn first, with habitual contact lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.	Habitual / Lotrafilcon B Habitual contact lenses worn first, with lotrafilcon B lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.
Period 1, 4 Weeks of Wear STARTED	23	26
Period 1, 4 Weeks of Wear COMPLETED	22	26
Period 1, 4 Weeks of Wear NOT COMPLETED	1	0
Period 2, 4 Weeks of Wear STARTED	22	25
Period 2, 4 Weeks of Wear COMPLETED	21	25
Period 2, 4 Weeks of Wear NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Lotrafilcon B / Habitual Lotrafilcon B contact lenses worn first, with habitual contact lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.	Habitual / Lotrafilcon B Habitual contact lenses worn first, with lotrafilcon B lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.
Period 1, 4 Weeks of Wear Failed inclusion/exclusion	1	0
Period 2, 4 Weeks of Wear Relocation	1	0

Baseline Characteristics

Subjective Evaluation of a Commercially Marketed Contact Lens Amongst a Subset of the Contact Lens Wearing Population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=49 Participants This reporting group includes all enrolled and dispensed subjects
Age Continuous	30.4 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks of wear

Population: Analysis conducted per protocol, with exclusions due to major protocol deviations as determined by masked review.

Comfort upon insertion, as interpreted by the participant, was recorded on a questionnaire by the participant using a 10-point scale, with 1 being poor and 10 being excellent. Comfort upon insertion was assessed as a single, retrospective evaluation of 4-weeks' wear time.

Outcome measures

Outcome measures
Measure	Lotrafilcon B n=47 Participants Commercially marketed, silicone hydrogel, spherical contact lens having a recommended replacement schedule of 30 days.	Habitual n=46 Participants Habitual soft spherical contact lens having a recommended replacement schedule of 2 weeks or monthly.
Comfort Upon Insertion	8.7 Units on a Scale Standard Deviation 2.0	9.2 Units on a Scale Standard Deviation 0.9

Adverse Events

Lotrafilcon B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Habitual

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

Email: [email protected]

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 preclinical and/or clinical data or impressions from this trial.
Publication restrictions are in place

Restriction type: OTHER