Trial Outcomes & Findings for Toric Contact Lens Performance Study (NCT NCT03546647)

NCT ID: NCT03546647

Last Updated: 2021-06-07

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. The test started at 20/200 and continued until three letters were missed on a line.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 35 participants
• Primary outcome timeframe: 10 +/- 2 days
• Results posted on: 2021-06-07

Participant Flow

37 participants were screened for eligibility between March and November 2018.

35 of 37 participants were randomized. Of those not randomized, 2 did not meet inclusion criteria. One randomized subject was removed from the study due to an adverse event.

Participant milestones

Measure	Toric, Then Sphere Participants who received Toric contact lenses first and spherical lenses after 10 days	Sphere, Then Toric Participants who received Sphere contact lenses first and Toric lenses after 10 days
Overall Study STARTED	18	17
Overall Study COMPLETED	17	17
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Toric, Then Sphere Participants who received Toric contact lenses first and spherical lenses after 10 days	Sphere, Then Toric Participants who received Sphere contact lenses first and Toric lenses after 10 days
Overall Study Adverse Event	1	0

Baseline Characteristics

Toric Contact Lens Performance Study

Baseline characteristics by cohort

Measure	All Study Participants n=34 Participants Toric group: Participants who received Toric contact lenses first and spherical lenses after 10 days Sphere group: Participants who received spherical contact lenses first and Toric lenses after 10 days
Age, Customized Male	22.2 years STANDARD_DEVIATION 2.7 • n=5 Participants
Age, Customized Female	27.5 years STANDARD_DEVIATION 5.3 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 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	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 +/- 2 days

Population: All participants who received each intervention and completed all study visits were included in the efficacy analysis.

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. The test started at 20/200 and continued until three letters were missed on a line.

Outcome measures

Measure	Toric n=34 Participants Participants who wore Toric contact lenses for 10 days	Sphere n=34 Participants Participants who wore Spherical contact lenses for 10 days
Near Visual LogMAR Acuity	-0.09 LogMAR Standard Deviation 0.07	-0.02 LogMAR Standard Deviation 0.09

Adverse Events

Toric

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Sphere

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 n=34 participants at risk Soft toric contact lens Dailies Aqua Comfort Plus Toric: Daily disposable soft toric contact lens	Sphere n=34 participants at risk Soft sphere contact lens Dailies Aqua Comfort Plus Sphere: Daily disposable soft spherical contact lens
Eye disorders Keratitis	2.9% 1/34 • Number of events 1 • 10 ± 2 days for each intervention AE information was collected at each study visit	0.00% 0/34 • 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@central.uh.edu

Results disclosure agreements

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