Trial Outcomes & Findings for Efficacy of Scleral Contact Lenses for Daily Wear for Regular and Irregular Refractive Errors Compared to Habitually Worn Scleral Lenses (NCT NCT02643095)

Results Overview

Number of Participants with Overall Satisfaction and Desire to Continue Wearing the Study Lenses

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

1 month after lens is dispensed

Results posted on

2023-12-06

Participant milestones
Measure	Lens Fitting/Evaluation This study was conducted with subjects who already habitually wore scleral contact lenses. The study lens was made with a material that is already widely available and has a new design. It was fit by the investigators and assessed one week and 1 month of wear. scleral contact lens: Scleral contact lens
Overall Study STARTED	22
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	1

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Lens Fitting/Evaluation n=22 Participants This study was conducted with subjects who already habitually wear scleral contact lenses. The study lens is made with a material that is already widely available and has a new design. It was fit by the investigators and assessed and at one week and 1 month. scleral contact lens: Scleral contact lens
Age, Customized Age 18 or older	22 Participants n=22 Participants
Sex: Female, Male Female	9 Participants n=22 Participants
Sex: Female, Male Male	13 Participants n=22 Participants

Timeframe: 1 month after lens is dispensed

Number of Participants with Overall Satisfaction and Desire to Continue Wearing the Study Lenses

Outcome measures
Measure	Lens Fitting/Evaluation n=21 Participants This study was conducted with subjects who already habitually wear scleral contact lenses. The study lens is made with a material that is already widely available and has a new design. It was fit by the investigators and assessed and at one week and 1 month. scleral contact lens: Scleral contact lens
The Primary Endpoint of the Study is the Overall Satisfaction and Desire to Continue Wearing the Study Lenses Preferred test lenses to habitual lenses	15 Participants
The Primary Endpoint of the Study is the Overall Satisfaction and Desire to Continue Wearing the Study Lenses No preference	4 Participants
The Primary Endpoint of the Study is the Overall Satisfaction and Desire to Continue Wearing the Study Lenses Preferred habitual lenses to test lenses	2 Participants

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Lens Fitting/Evaluation n=21 participants at risk This study was conducted with subjects who already habitually wear scleral contact lenses. The study lens is made with a material that is already widely available and has a new design. It was fit by the investigators and assessed and at one week and 1 month. scleral contact lens: Scleral contact lens
Eye disorders punctate keratitis	4.8% 1/21 • Number of events 1 • Adverse event data was collected at all study visits, including a visit after 1 week and 1 month of lens wear.

The Ohio State University College of Optometry

Phone: 614-292-2020