Trial Outcomes & Findings for Clinical Evaluation of Two Daily Disposable Lenses in Neophytes (NCT NCT00987623)

Results Overview

Overall Lens Satisfaction, as interpreted by the participant and reported 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

326 participants

Primary outcome timeframe

1 week

Results posted on

2012-07-10

Participant Flow

Twenty-seven participants were enrolled but not dispensed. These participants were included in the Actual Enrollment calculation, but not in Participant Flow or Baseline Characteristics calculations.

Participant milestones

Participant milestones
Measure	Nelfilcon A Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.	Narafilcon A Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
Overall Study STARTED	145	154
Overall Study COMPLETED	140	151
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Nelfilcon A Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.	Narafilcon A Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
Overall Study Lost to Follow-up	2	1
Overall Study Time/job conflict	2	0
Overall Study Discomfort	1	0
Overall Study Biomicroscopy	0	1
Overall Study Influenza	0	1

Baseline Characteristics

Clinical Evaluation of Two Daily Disposable Lenses in Neophytes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nelfilcon A n=145 Participants Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.	Narafilcon A n=154 Participants Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.	Total n=299 Participants Total of all reporting groups
Age Continuous	26.5 years STANDARD_DEVIATION 9.8 • n=5 Participants	26.5 years STANDARD_DEVIATION 10.5 • n=7 Participants	26.5 years STANDARD_DEVIATION 10.12 • n=5 Participants
Sex: Female, Male Female	94 Participants n=5 Participants	99 Participants n=7 Participants	193 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	55 Participants n=7 Participants	106 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week

Population: Analysis conducted per protocol, with exclusions due to major protocol deviations as determined by masked review, discontinuations, and/or missing responses.

Overall Lens Satisfaction, as interpreted by the participant and reported 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 n=128 Participants Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.	Narafilcon A n=138 Participants Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
Overall Lens Satisfaction	7.9 Units on a Scale Standard Deviation 1.7	7.9 Units on a Scale Standard Deviation 1.6

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