Trial Outcomes & Findings for Clinical Evaluation of a Silicone Hydrogel Lens (NCT NCT01016132)

Results Overview

Overall preference when comparing study lenses to "habitual" lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of four weeks' wear time. Overall preference was measured on a 5-point Likert scale as follows: Strongly Prefer Study Lenses; Somewhat Prefer Study Lenses; No Preference; Somewhat Prefer "Habitual" Lenses; Strongly Prefer "Habitual" Lenses.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

152 participants

Primary outcome timeframe

4 weeks of wear

Results posted on

2012-06-29

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis.
Overall Study STARTED	152
Overall Study COMPLETED	151
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis.
Overall Study Discomfort	1

Baseline Characteristics

Clinical Evaluation of a Silicone Hydrogel Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=152 Participants In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis.
Age Continuous	33.5 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	97 Participants n=5 Participants
Sex: Female, Male Male	55 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks 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.

Overall preference when comparing study lenses to "habitual" lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of four weeks' wear time. Overall preference was measured on a 5-point Likert scale as follows: Strongly Prefer Study Lenses; Somewhat Prefer Study Lenses; No Preference; Somewhat Prefer "Habitual" Lenses; Strongly Prefer "Habitual" Lenses.

Outcome measures

Outcome measures
Measure	All Participants n=145 Participants In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis.
Overall Preference Strongly Prefer Study Lenses	28 Participants
Overall Preference Somewhat Prefer Study Lenses	31 Participants
Overall Preference NO Preference	46 Participants
Overall Preference Somewhat Prefer "Habitual" Lenses	20 Participants
Overall Preference Strongly Prefer "Habitual" Lenses	20 Participants

Adverse Events

All Participants

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