Trial Outcomes & Findings for Clinical Evaluation of Fitting Investigational Contact Lenses Phase 2 (NCT NCT03168542)

Results Overview

The ECP followed the fitting guide to assess the vision provided by the study lenses and determined if a lens change was needed. The ECP modified the lenses based upon the subject's responses in accordance with the Fitting Guide. Two modifications were allowed. The number of modifications required by the ECP to optimize vision was recorded.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

15 Minutes Post Lens Fitting

Results posted on

2018-10-19

Participant Flow

A total of 23 subjects were enrolled into this study. Of the enrolled subjects 21 were dispensed a study lens and 2 subjects failed to meet the eligibility criteria. Of the dispensed subjects all 21 completed the study.

This was a non-randomized study. The JJVC fitting guide, subjects responses and eye car practitioner options dictated which study lens the subject was to be fit with. Lens type and lens sequence are not experimental design factors. The first lens pair (Right/Left) on eye was the same lens pair (Right/Left) the subject ended with.

Participant milestones

Participant milestones
Measure	Toric Multifocal/Toric Multifocal Subjects that wore the Toric Multifocal contact lens in both eyes (Right/Left) for the entire duration of the study.	Toric Multifocal/ Multifocal Subjects that wore the Toric Multifocal contact lens in their right eye and the Sphere Multifocal contact lens in their left eye for the entire duration of the study.	Multifocal/Toric Multifocal Subjects that wore the Sphere Multifocal contact lens in their right eye and the Toric Multifocal contact lens in their left eye for the entire duration of the study.
Overall Study STARTED	7	5	9
Overall Study COMPLETED	7	5	9
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation of Fitting Investigational Contact Lenses Phase 2

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dispensed Subjects n=21 Participants All subjects dispensed at least one study lens.
Age, Continuous	57.0 Years STANDARD_DEVIATION 6.05 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=5 Participants
Race/Ethnicity, Customized White	17 Participants n=5 Participants
Region of Enrollment United States	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: 15 Minutes Post Lens Fitting

Population: All subjects that completed the study without a major protocol deviation.

The ECP followed the fitting guide to assess the vision provided by the study lenses and determined if a lens change was needed. The ECP modified the lenses based upon the subject's responses in accordance with the Fitting Guide. Two modifications were allowed. The number of modifications required by the ECP to optimize vision was recorded.