Trial Outcomes & Findings for Clinical Evaluation of Two Daily Disposable Lenses in a Population of Daily Disposable (DD) Lens Wearers (NCT NCT00958828)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

178 participants

Primary outcome timeframe

After 1 week of wear

Results posted on

2012-07-10

Participant Flow

Participant milestones

Participant milestones
Measure	Nelfilcon A / Narafilcon A Nelfilcon A contact lenses, then Narafilcon A contact lenses	Narafilcon A / Nelfilcon A Narafilcon A contact lenses, then Nelfilcon A contact lenses
Period 1, 1 Week of Wear STARTED	89	89
Period 1, 1 Week of Wear COMPLETED	89	88
Period 1, 1 Week of Wear NOT COMPLETED	0	1
Period 2, 1 Week of Wear STARTED	89	88
Period 2, 1 Week of Wear COMPLETED	89	87
Period 2, 1 Week of Wear NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Nelfilcon A / Narafilcon A Nelfilcon A contact lenses, then Narafilcon A contact lenses	Narafilcon A / Nelfilcon A Narafilcon A contact lenses, then Nelfilcon A contact lenses
Period 1, 1 Week of Wear Randomization break	0	1
Period 2, 1 Week of Wear Unacceptable lens fit	0	1

Baseline Characteristics

Clinical Evaluation of Two Daily Disposable Lenses in a Population of Daily Disposable (DD) Lens Wearers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=178 Participants This reporting group includes all enrolled and dispensed subjects.
Age Continuous	30.0 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	111 Participants n=5 Participants
Sex: Female, Male Male	67 Participants n=5 Participants

PRIMARY outcome

Timeframe: After 1 week of wear

Population: Per protocol

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

Outcome measures

Outcome measures
Measure	Nelfilcon A Contact Lens n=174 Participants Spherical, soft contact lens for daily disposable wear	Narafilcon A Contact Lens n=175 Participants Spherical, soft contact lens for daily disposable wear
Overall Lens Satisfaction	7.5 Units on a scale Standard Deviation 2.2	7.5 Units on a scale Standard Deviation 2.3

Adverse Events

Nelfilcon A Contact Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Narafilcon 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