Trial Outcomes & Findings for Assessment of Lotrafilcon A Contact Lenses (NCT NCT01185834)

Results Overview

As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

118 participants

Primary outcome timeframe

3 months of wear, replacing lenses monthly

Results posted on

2012-07-10

Participant Flow

Thirteen US optometry sites recruited and enrolled subjects for this study.

Participant milestones

Participant milestones
Measure	Lotrafilcon A Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
Overall Study STARTED	118
Overall Study COMPLETED	104
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Lotrafilcon A Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
Overall Study Lost to Follow-up	2
Overall Study Discomfort	4
Overall Study Biomicroscopy	4
Overall Study Time/Job Conflict	2
Overall Study Early exit - Site error	2

Baseline Characteristics

Assessment of Lotrafilcon A Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lotrafilcon A n=118 Participants Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
Age Continuous	34.1 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	84 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months of wear, replacing lenses monthly

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.

As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.

Outcome measures

Outcome measures
Measure	Lotrafilcon A n=103 Participants Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
Overall Comfort	8.4 units on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: 3 months of wear, replacing lenses monthly

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.

As assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded by eye on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight

Outcome measures

Outcome measures
Measure	Lotrafilcon A n=206 Eyes Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
Overall Lens Fit	0.0 units on a scale Standard Deviation 0.3

Adverse Events

Lotrafilcon 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

Sameena Haque-Khan, PhD, BSc(Hons)Optom, MCOptom, FAAO

Alcon Research, Ltd.

Phone: 1-800-241-7629

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