Trial Outcomes & Findings for Clinical Comparison of Two Silicone Hydrogel Toric Lenses in the US (NCT NCT01007812)

Results Overview

Overall vision, as interpreted by the subject and reported by the subject on a questionnaire as a single, retrospective evaluation of one week's wear time. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

After 1 week of wear

Results posted on

2012-06-29

Participant Flow

Participant milestones

Participant milestones
Measure	Lotrafilcon B / Comfilcon A Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week, followed by Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week. Both products worn in a daily wear modality.	Comfilcon A / Lotrafilcon B Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week, followed by Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week. Both products worn in a daily wear modality.
Period 1, One Week STARTED	25	25
Period 1, One Week COMPLETED	24	24
Period 1, One Week NOT COMPLETED	1	1
Period 2, One Week STARTED	24	24
Period 2, One Week COMPLETED	24	24
Period 2, One Week NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Lotrafilcon B / Comfilcon A Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week, followed by Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week. Both products worn in a daily wear modality.	Comfilcon A / Lotrafilcon B Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week, followed by Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week. Both products worn in a daily wear modality.
Period 1, One Week Lost to Follow-up	0	1
Period 1, One Week Discomfort	1	0

Baseline Characteristics

Clinical Comparison of Two Silicone Hydrogel Toric Lenses in the US

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=50 Participants This reporting group includes all enrolled and dispensed subjects.
Age Continuous	33.4 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: After 1 week of wear

Population: Per Protocol

Overall vision, as interpreted by the subject and reported by the subject on a questionnaire as a single, retrospective evaluation of one week's wear time. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.

Outcome measures

Outcome measures
Measure	Lotrafilcon B Contact Lens n=48 Participants Silicone hydrogel, toric, soft contact lens	Comfilcon A Contact Lens n=48 Participants Silicone hydrogel, toric, soft contact lens
Overall Vision	8.2 Units on a Scale Standard Deviation 1.8	8.3 Units on a Scale Standard Deviation 1.8

Adverse Events

Lotrafilcon B Contact Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Comfilcon A Contact Lens

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