Trial Outcomes & Findings for Toric Contact Lens Digital Performance and Comfort Study (NCT NCT04772560)

NCT ID: NCT04772560

Last Updated: 2022-03-10

Results Overview

High contrast LogMAR visual acuity was assessed at 40 cm using the M\&S Clinical Trial Suite system (Niles, Illinois, USA). The system was calibrated according to the manufacturer's directions every day, prior to use. Testing was performed binocularly 10+/-2 days after each intervention. The test started at 20/60 and continued until three letters were missed on a line.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: 10 +/- 2 days
• Results posted on: 2022-03-10

Participant Flow

30 participants were screened for eligibility between March and December 2021

23 of 30 participants were randomized. Of those not randomized, 7 did not meet inclusion criteria.

Participant milestones

Measure	Toric Then Spherical Participants who received toric contact lenses first and spherical lenses after 10 days	Spherical Then Toric Participants who received spherical contact lenses first and toric lenses after 10 days
Overall Study STARTED	11	12
Overall Study COMPLETED	11	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Toric Contact Lens Digital Performance and Comfort Study

Baseline characteristics by cohort

Measure	All Participants n=23 Participants 23 participants who had completed the study
Age, Continuous	24.4 years STANDARD_DEVIATION 4.2 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	8 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	3 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 +/- 2 days

High contrast LogMAR visual acuity was assessed at 40 cm using the M&S Clinical Trial Suite system (Niles, Illinois, USA). The system was calibrated according to the manufacturer's directions every day, prior to use. Testing was performed binocularly 10+/-2 days after each intervention. The test started at 20/60 and continued until three letters were missed on a line.

Outcome measures

Measure	All Participants n=23 Participants 23 participants who had completed the study
Near Visual LogMAR Acuity Toric CL	-0.10 LogMAR Standard Error 0.02
Near Visual LogMAR Acuity Spherical CL	-0.03 LogMAR Standard Error 0.21

PRIMARY outcome

Timeframe: 10 +/- 2 days

Dynamic VA was determined using a custom-made iPad application. The subject was instructed to hold the iPad at 40cm and presented with a Landolt C surrounded by crowding bars for 0.3s each, starting from 0.5 LogMAR and progressing to smaller sizes using a staircase threshold method. Testing was performed binocularly 10+/-2 days after each intervention

Outcome measures

Measure	All Participants n=23 Participants 23 participants who had completed the study
Dynamic Visual Acuity Toric CL	0.04 LogMAR Standard Error 0.02
Dynamic Visual Acuity Spherical CL	0.11 LogMAR Standard Error 0.02

Adverse Events

Toric Contact Lens Wear

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Spherical Contact Lens Wear

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Toric Contact Lens Wear n=23 participants at risk 23 participants had completed the study	Spherical Contact Lens Wear n=23 participants at risk 23 participants had completed the study
Eye disorders Corneal staining	13.0% 3/23 • Number of events 3 • 10 ± 2 days for each intervention AE information was collected at each study visit	0.00% 0/23 • 10 ± 2 days for each intervention AE information was collected at each study visit
Eye disorders Hordeolum	4.3% 1/23 • Number of events 1 • 10 ± 2 days for each intervention AE information was collected at each study visit	0.00% 0/23 • 10 ± 2 days for each intervention AE information was collected at each study visit

Additional Information

Kathryn Richdale OD, PhD

University of Houston

Phone: 713-743-1974

Email: richdale@uh.edu

Results disclosure agreements

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