Trial Outcomes & Findings for Evaluation of Lotrafilcon A Lenses Over a Three Month Period (NCT NCT00931307)

Results Overview

Comfort after insertion of contact lens (30 seconds to 1 minute), as interpreted by the subject and reported by the subject as a single, retrospective evaluation of 3-month's 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

22 participants

Primary outcome timeframe

3 months

Results posted on

2012-06-29

Participant Flow

Participant milestones

Participant milestones
Measure	Lotrafilcon A Silicone hydrogel, spherical, experimental soft contact lenses worn on the same basis as habitual contact lenses as prescribed by eye care practitioner
Overall Study STARTED	22
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Lotrafilcon A Silicone hydrogel, spherical, experimental soft contact lenses worn on the same basis as habitual contact lenses as prescribed by eye care practitioner
Overall Study Lack of Efficacy	12
Overall Study Biomicroscopy	1

Baseline Characteristics

Evaluation of Lotrafilcon A Lenses Over a Three Month Period

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lotrafilcon A n=22 Participants Silicone hydrogel, spherical, soft contact lens
Age Continuous	32.4 years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Per protocol. Analysis excluded major protocol deviations as determined by masked review.

Comfort after insertion of contact lens (30 seconds to 1 minute), as interpreted by the subject and reported by the subject as a single, retrospective evaluation of 3-month's 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=9 Participants Silicone hydrogel, spherical, soft contact lens
Comfort After Insertion	7.9 Scale of 1 to 10 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