Trial Outcomes & Findings for Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Daily Disposable Lens Wearers (NCT NCT01035905)

Results Overview

Lens awareness, as interpreted by the subject and reported by the subject in a questionnaire as a single, retrospective evaluation of 4-week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being always. Four-week ratings were compared to baseline ratings, and a negative difference (4 week minus baseline) represented an improvement.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

63 participants

Primary outcome timeframe

4 weeks of wear

Results posted on

2012-07-10

Participant Flow

Participant milestones

Participant milestones
Measure	Nelfilcon A Nelfilcon A contact lens	Narafilcon A Narafilcon A contact lens
Overall Study STARTED	32	31
Overall Study COMPLETED	31	30
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Nelfilcon A Nelfilcon A contact lens	Narafilcon A Narafilcon A contact lens
Overall Study Lack of Efficacy	1	1

Baseline Characteristics

Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Daily Disposable Lens Wearers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nelfilcon A n=32 Participants Nelfilcon A contact lens	Narafilcon A n=31 Participants Narafilcon A contact lens	Total n=63 Participants Total of all reporting groups
Age Continuous	31.7 years STANDARD_DEVIATION 8.4 • n=93 Participants	35.7 years STANDARD_DEVIATION 11.9 • n=4 Participants	33.7 years STANDARD_DEVIATION 10.4 • n=27 Participants
Sex: Female, Male Female	17 Participants n=93 Participants	24 Participants n=4 Participants	41 Participants n=27 Participants
Sex: Female, Male Male	15 Participants n=93 Participants	7 Participants n=4 Participants	22 Participants n=27 Participants

PRIMARY outcome

Timeframe: 4 weeks of wear

Population: Per Protocol

Lens awareness, as interpreted by the subject and reported by the subject in a questionnaire as a single, retrospective evaluation of 4-week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being always. Four-week ratings were compared to baseline ratings, and a negative difference (4 week minus baseline) represented an improvement.

Outcome measures

Outcome measures
Measure	Nelfilcon A n=31 Participants Nelfilcon A contact lens	Narafilcon A n=30 Participants Narafilcon A contact lens
Lens Awareness	8 Participants	9 Participants

Adverse Events

Nelfilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Narafilcon 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