Trial Outcomes & Findings for Evaluation of Two Daily Disposable Contact Lenses for Wearers With Astigmatism (NCT NCT01207466)

Results Overview

Quality of vision (crisp and clear), as interpreted and reported by the participant by eye on a questionnaire as a single, retrospective evaluation of one week's wear time. Quality of vision was assessed on a 10-point scale, with 1 being poor and 10 being excellent.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

95 participants

Primary outcome timeframe

1 week of wear

Results posted on

2012-07-10

Participant Flow

This reporting group includes all enrolled and dispensed participants. One participant was enrolled but not dispensed due to unacceptable fit. This participant is included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.

Participant milestones

Participant milestones
Measure	Nelfilcon A Invest'l / nelfilconA Comm'l Nelfilcon A investigational toric contact lenses worn first, with nelfilcon A commercial toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week.	Nelfilcon A Comm'l / nelfilconA Invest'l Nelfilcon A commercial toric contact lenses worn first, with nelfilcon A investigational toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week.
Period 1, One Week of Wear STARTED	46	48
Period 1, One Week of Wear COMPLETED	46	48
Period 1, One Week of Wear NOT COMPLETED	0	0
Period 2, One Week of Wear STARTED	45	48
Period 2, One Week of Wear COMPLETED	45	48
Period 2, One Week of Wear NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Two Daily Disposable Contact Lenses for Wearers With Astigmatism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=94 Participants This reporting group includes all enrolled and dispensed subjects.
Age Continuous	35.8 years STANDARD_DEVIATION 12.2 • n=93 Participants
Sex: Female, Male Female	56 Participants n=93 Participants
Sex: Female, Male Male	38 Participants n=93 Participants

PRIMARY outcome

Timeframe: 1 week of wear

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

Quality of vision (crisp and clear), as interpreted and reported by the participant by eye on a questionnaire as a single, retrospective evaluation of one week's wear time. Quality of vision was assessed on a 10-point scale, with 1 being poor and 10 being excellent.

Outcome measures

Outcome measures
Measure	Nelfilcon A Investigational n=184 eyes Investigational, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week.	Nelfilcon A Commercial n=182 eyes Commercially marketed, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week.
Quality of Vision (Crisp and Clear)	8.8 units on a scale Standard Deviation 1.3	8.6 units on a scale Standard Deviation 1.5

Adverse Events

Nelfilcon A Investigational

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nelfilcon A Commercial

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

Joe Rappon, OD, MS, FAAO / Head, Clinical Trial Management

CIBA VISION

Phone: 1-678-415-3343

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