Trial Outcomes & Findings for Assessing the Performance of Lotrafilcon A Lenses During a Three Month Period (NCT NCT00933166)

Results Overview

Comfort after insertion (30 seconds to 1 minute) as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of three months' wear time. Comfort after insertion was measured on a 10-point scale, with 1 being poor and 10 being excellent.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

169 participants

Primary outcome timeframe

3 months

Results posted on

2012-07-10

Participant Flow

Participant milestones

Participant milestones
Measure	Lotrafilcon A Investigational contact lens worn in both eyes for three months
Overall Study STARTED	169
Overall Study COMPLETED	151
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Lotrafilcon A Investigational contact lens worn in both eyes for three months
Overall Study Lost to Follow-up	4
Overall Study Lack of Efficacy	9
Overall Study Unavailable	4
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Assessing the Performance of Lotrafilcon A Lenses During a Three Month Period

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lotrafilcon A n=169 Participants Investigational contact lens worn in both eyes for three months
Age Continuous	37.3 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	115 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Analysis was per protocol and excluded ten major protocol deviations as determined by masked review. Eighteen participants discontinued prior to the Month 3 visit. Nineteen participants responded N/A due to reasons such as continual wear.

Comfort after insertion (30 seconds to 1 minute) as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of three months' wear time. Comfort after insertion was measured on a 10-point scale, with 1 being poor and 10 being excellent.

Outcome measures

Outcome measures
Measure	Lotrafilcon A n=122 Participants Investigational contact lens worn in both eyes for three months
Comfort After Insertion	9.0 Units on a Scale Standard Deviation 1.6

Adverse Events

Lotrafilcon 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

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