Trial Outcomes & Findings for Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers (NCT NCT06053463)

NCT ID: NCT06053463

Last Updated: 2024-11-27

Results Overview

Visual Analog Scale survey of lens wear symptoms (vision) with contact lenses; percentage of participants with positive scores (\> 50).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 35 participants
• Primary outcome timeframe: 1 month
• Results posted on: 2024-11-27

Participant Flow

Participant milestones

Measure	Lens Wear Experience Subject will wear contact lenses for about a month during the day. Daily disposable multifocal soft contact lens: Daily disposable multifocal soft contact lens that will be worn for 1 month.
Overall Study STARTED	35
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers

Baseline characteristics by cohort

Measure	Lens Wear Experience n=25 Participants Subject will wear contact lenses for about a month during the day. Daily disposable multifocal soft contact lens: Daily disposable multifocal soft contact lens that will be worn for 1 month.
Age, Continuous	54 years STANDARD_DEVIATION 6.6 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Population: Participants

Visual Analog Scale survey of lens wear symptoms (vision) with contact lenses; percentage of participants with positive scores (> 50).

Outcome measures

Measure	Lens Wear Experience n=25 Participants Subject will wear contact lenses for about a month during the day. Daily disposable multifocal soft contact lens: Daily disposable multifocal soft contact lens that will be worn for 1 month.
Visual Analog Scale	22 Participants

PRIMARY outcome

Timeframe: 1 month

Population: Participants

Assessment of the participant's quality of life with the daily disposable multifocal contact lenses; percentage of participants with VAS scores greater than 50 on satisfaction survey.

Outcome measures

Measure	Lens Wear Experience n=24 Participants Subject will wear contact lenses for about a month during the day. Daily disposable multifocal soft contact lens: Daily disposable multifocal soft contact lens that will be worn for 1 month.
Quality of Life Survey	22 Participants

Adverse Events

Lens Wear Experience

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: 614-292-0882

Email: fogt.78@osu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place