Trial Outcomes & Findings for Evaluation of Wear Experience With a Daily Disposable Contact Lens (NCT NCT04296877)

Last Updated: 2023-03-07

Results Overview

Participants complete the Contact Lens Dry Eye Questionnaire (CLDEQ-8) survey. This is an 8 question survey assesses symptoms while wearing contact lenses with possible scores from 0 (no symptoms) to 37 (maximum symptoms). Higher scores indicate worsening symptoms of dry eye while wearing lenses.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

2 weeks

Results posted on

2023-03-07

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm Study All subjects are re-fit into their habitual reusable soft contact lenses to optimize vision. Subjects are requested to wear the lenses for one week, for a minimum of at least 6 hours per day for 5 days. Subjects then return and are fit with the daily disposable soft contact lens. After wearing the daily disposable lenses, participants return to assess vision and lens fit and answer surveys about their experience.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Wear Experience With a Daily Disposable Contact Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants Wear Study Daily Disposable Contact Lenses n=30 Participants All subjects are re-fit into their habitual reusable soft contact lenses to optimize vision. Subjects are requested to wear the lenses for one week, for a minimum of at least 6 hours per day for 5 days. Subjects then return and are fit with the daily disposable soft contact lens. After wearing the daily disposable lenses, participants return to assess vision and lens fit and answer surveys about their experience.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	29.1 years STANDARD_DEVIATION 7.8 • n=93 Participants
Sex: Female, Male Female	19 Participants n=93 Participants
Sex: Female, Male Male	11 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	3 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	25 Participants n=93 Participants
Race (NIH/OMB) More than one race	2 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	30 Participants n=93 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: All subjects were in the same arm, and wore both types of lenses. This was not a comparative study.

Outcome measures

Outcome measures
Measure	All Study Participants n=30 Participants All subjects are re-fit into their habitual reusable soft contact lenses to optimize vision. Subjects are requested to wear the lenses for one week, for a minimum of at least 6 hours per day for 5 days. Subjects then return and are fit with the daily disposable soft contact lens. After wearing the daily disposable lenses, participants return to assess vision and lens fit and answer surveys about their experience.
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Survey	9.5 units on a scale Interval 6.0 to 17.75

Adverse Events

All Study 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

Jennifer Fogt

The Ohio State University College of Optometry

Phone: 16142928858

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place