Trial Outcomes & Findings for Evaluation of Two Silicone Hydrogel Lenses Over a One Month Period (NCT NCT00810511)

Last Updated: 2023-12-05

Results Overview

Evaluated by the subject as a single, retrospective evaluation of 4-week wear time. Measured on a 10-point scale, with 1 being poor and 10 being excellent.

Recruitment status

COMPLETED

Study phase

Target enrollment

213 participants

Primary outcome timeframe

After 4 weeks of wear

Results posted on

2023-12-05

Participant Flow

Participant milestones

Participant milestones
Measure	Lotrafilcon A Investigational, spherical, silicone hydrogel contact lenses	Comfilcon A Commercially marketed, spherical, silicone hydrogel contact lenses
Overall Study STARTED	107	106
Overall Study COMPLETED	97	102
Overall Study NOT COMPLETED	10	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Lotrafilcon A Investigational, spherical, silicone hydrogel contact lenses	Comfilcon A Commercially marketed, spherical, silicone hydrogel contact lenses
Overall Study Protocol Violation	0	1
Overall Study Lack of Efficacy	9	1
Overall Study death in the family	0	1
Overall Study Lost to Follow-up	1	0
Overall Study deposits on contact lens	0	1

Baseline Characteristics

Evaluation of Two Silicone Hydrogel Lenses Over a One Month Period

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lotrafilcon A n=107 Participants Investigational, spherical, silicone hydrogel contact lenses	Comfilcon A n=106 Participants Commercially marketed, spherical, silicone hydrogel contact lenses	Total n=213 Participants Total of all reporting groups
Age, Categorical <=18 years	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	96 Participants n=5 Participants	96 Participants n=7 Participants	192 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	30.6 years STANDARD_DEVIATION 9.8 • n=5 Participants	31.8 years STANDARD_DEVIATION 11.0 • n=7 Participants	31.2 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	84 Participants n=5 Participants	84 Participants n=7 Participants	168 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Region of Enrollment United States	107 participants n=5 Participants	106 participants n=7 Participants	213 participants n=5 Participants

PRIMARY outcome

Timeframe: After 4 weeks of wear

Population: One subject in the Lotrafilcon A arm was excluded from efficacy analysis due to a protocol deviation.

Evaluated by the subject as a single, retrospective evaluation of 4-week wear time. Measured on a 10-point scale, with 1 being poor and 10 being excellent.

Outcome measures

Outcome measures
Measure	Lotrafilcon A n=96 Participants Investigational, spherical, silicone hydrogel contact lenses	Comfilcon A n=102 Participants Commercially marketed, spherical, silicone hydrogel contact lenses
Comfort at End of Day	6.5 Scale of 1-10 Standard Deviation 2.4	6.9 Scale of 1-10 Standard Deviation 2.4

Adverse Events

Lotrafilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Comfilcon 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