Trial Outcomes & Findings for Evaluation of Wear Experience With Daily Disposable and Monthly Replacement Toric Contact Lenses (NCT NCT05580575)

NCT ID: NCT05580575

Last Updated: 2024-04-29

Results Overview

Visual analog scale survey of comfort from 0 to 100, with 0 anchored as "poor" and 100 as "excellent"

Recruitment status

COMPLETED

Study phase

Target enrollment

67 participants

Primary outcome timeframe

1 month

Results posted on

2024-04-29

Participant Flow

There were 4 screen failures at the first visit.

Participant milestones

Participant milestones
Measure	Daily Disposable Lens Worn First, Reusable Lens Worn Second (30 Days) Subject will wear contact lenses for 30 days during the day only. Daily disposable toric soft contact lens: Daily disposable toric soft contact lens Monthly replacement toric daily wear soft contact lens: Monthly replacement toric daily wear soft contact lens	Reusable Lens Worn First, Daily Disposable Lens Worn Second (30 Days) Subject will wear contact lenses for 30 days during the day only. Daily disposable toric soft contact lens: Daily disposable toric soft contact lens Monthly replacement toric daily wear soft contact lens: Monthly replacement toric daily wear soft contact lens
Overall Study STARTED	31	32
Overall Study COMPLETED	28	31
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Drop out subjects were not analyzed.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 1 month

Visual analog scale survey of comfort from 0 to 100, with 0 anchored as "poor" and 100 as "excellent"

Outcome measures

Outcome measures
Measure	Daily Disposable Lens n=59 Participants Daily disposable toric soft contact lens: Daily disposable toric soft contact lens	Reusable Lens n=59 Participants Monthly replacement toric daily wear soft contact lens: Monthly replacement toric daily wear soft contact lens
Visual Analog Scale Survey of Overall Comfort	71.6 units on a scale Standard Deviation 26.3	63.2 units on a scale Standard Deviation 28.9

Adverse Events

Daily Disposable Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Reusable Lens

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

Dr. Jennifer Fogt, OD, MS

The Ohio State University College of Optometry

Phone: 614-292-0882

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Daily Disposable Lens Worn First, Reusable Lens Worn Second n=28 Participants Subject will wear contact lenses for 30 days during the day only. Daily disposable toric soft contact lens: Daily disposable toric soft contact lens Monthly replacement toric daily wear soft contact lens: Monthly replacement toric daily wear soft contact lens	Reusable Lens Worn First, Daily Disposable Lens Worn Second n=31 Participants Subject will wear contact lenses for 30 days during the day only. Daily disposable toric soft contact lens: Daily disposable toric soft contact lens Monthly replacement toric daily wear soft contact lens: Monthly replacement toric daily wear soft contact lens	Total n=59 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants • Drop out subjects were not analyzed.	0 Participants n=7 Participants • Drop out subjects were not analyzed.	0 Participants n=5 Participants • Drop out subjects were not analyzed.
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants • Drop out subjects were not analyzed.	31 Participants n=7 Participants • Drop out subjects were not analyzed.	59 Participants n=5 Participants • Drop out subjects were not analyzed.
Age, Categorical >=65 years	0 Participants n=5 Participants • Drop out subjects were not analyzed.	0 Participants n=7 Participants • Drop out subjects were not analyzed.	0 Participants n=5 Participants • Drop out subjects were not analyzed.
Age, Continuous	31 years STANDARD_DEVIATION 10.8 • n=5 Participants • Drop out subjects not analyzed.	31.9 years STANDARD_DEVIATION 9.2 • n=7 Participants • Drop out subjects not analyzed.	31.5 years STANDARD_DEVIATION 10 • n=5 Participants • Drop out subjects not analyzed.
Sex/Gender, Customized Female	18 Participants n=5 Participants • Drop out subjects not analyzed.	16 Participants n=7 Participants • Drop out subjects not analyzed.	34 Participants n=5 Participants • Drop out subjects not analyzed.
Sex/Gender, Customized Male	10 Participants n=5 Participants • Drop out subjects not analyzed.	12 Participants n=7 Participants • Drop out subjects not analyzed.	22 Participants n=5 Participants • Drop out subjects not analyzed.
Sex/Gender, Customized Transgender Female	0 Participants n=5 Participants • Drop out subjects not analyzed.	1 Participants n=7 Participants • Drop out subjects not analyzed.	1 Participants n=5 Participants • Drop out subjects not analyzed.
Sex/Gender, Customized Transgender Male	0 Participants n=5 Participants • Drop out subjects not analyzed.	1 Participants n=7 Participants • Drop out subjects not analyzed.	1 Participants n=5 Participants • Drop out subjects not analyzed.
Sex/Gender, Customized Nonbinary	0 Participants n=5 Participants • Drop out subjects not analyzed.	1 Participants n=7 Participants • Drop out subjects not analyzed.	1 Participants n=5 Participants • Drop out subjects not analyzed.
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants • Drop out subject data not analyzed.	4 Participants n=7 Participants • Drop out subject data not analyzed.	6 Participants n=5 Participants • Drop out subject data not analyzed.
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants • Drop out subject data not analyzed.	27 Participants n=7 Participants • Drop out subject data not analyzed.	52 Participants n=5 Participants • Drop out subject data not analyzed.
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants • Drop out subject data not analyzed.	0 Participants n=7 Participants • Drop out subject data not analyzed.	1 Participants n=5 Participants • Drop out subject data not analyzed.
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants • Drop out subjects not analyzed.	0 Participants n=7 Participants • Drop out subjects not analyzed.	1 Participants n=5 Participants • Drop out subjects not analyzed.
Race (NIH/OMB) Asian	4 Participants n=5 Participants • Drop out subjects not analyzed.	2 Participants n=7 Participants • Drop out subjects not analyzed.	6 Participants n=5 Participants • Drop out subjects not analyzed.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • Drop out subjects not analyzed.	0 Participants n=7 Participants • Drop out subjects not analyzed.	0 Participants n=5 Participants • Drop out subjects not analyzed.
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants • Drop out subjects not analyzed.	0 Participants n=7 Participants • Drop out subjects not analyzed.	1 Participants n=5 Participants • Drop out subjects not analyzed.
Race (NIH/OMB) White	22 Participants n=5 Participants • Drop out subjects not analyzed.	24 Participants n=7 Participants • Drop out subjects not analyzed.	46 Participants n=5 Participants • Drop out subjects not analyzed.
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • Drop out subjects not analyzed.	5 Participants n=7 Participants • Drop out subjects not analyzed.	5 Participants n=5 Participants • Drop out subjects not analyzed.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • Drop out subjects not analyzed.	0 Participants n=7 Participants • Drop out subjects not analyzed.	0 Participants n=5 Participants • Drop out subjects not analyzed.
Region of Enrollment United States	28 Participants n=5 Participants • Drop out subjects not analyzed.	31 Participants n=7 Participants • Drop out subjects not analyzed.	59 Participants n=5 Participants • Drop out subjects not analyzed.