Trial Outcomes & Findings for Vision Stability and Preference for Soft Toric vs. Soft Spherical Contact Lenses (NCT NCT04536571)

Results Overview

Vision stability was assessed by study subjects while doing tasks on mobile phone using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

27 participants

Primary outcome timeframe

30 minutes

Results posted on

2021-11-22

Participant Flow

Participant milestones

Participant milestones
Measure	Test Contact Lens Then Control Contact Lens Subjects were randomized to wear test lenses for 30 minutes, and then cross-over to control lenses.	Control Contact Lens Then Test Lens Subjects were randomized to wear control lenses for 30 minutes, and then cross-over to test lenses.
First Intervention STARTED	11	16
First Intervention COMPLETED	11	16
First Intervention NOT COMPLETED	0	0
Second Intervention STARTED	11	16
Second Intervention COMPLETED	11	16
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=27 Participants Subjects were randomized to wear either test or control lenses for 30 minutes and then cross-over to the other lens.
Age, Categorical <=18 years	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=27 Participants
Age, Continuous	28.7 years STANDARD_DEVIATION 7.9 • n=27 Participants
Sex: Female, Male Female	14 Participants n=27 Participants
Sex: Female, Male Male	13 Participants n=27 Participants
Region of Enrollment United Kingdom	27 participants n=27 Participants

PRIMARY outcome

Timeframe: 30 minutes

Vision stability was assessed by study subjects while doing tasks on mobile phone using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss)

Outcome measures

Outcome measures
Measure	Test Contact Lens n=27 Participants Subjects were randomized to wear test lenses for 30 minutes. Test Contact lens: contact lenses.	Control Contact Lens n=27 Participants Subjects were randomized to wear control lenses for 30 minutes. Control Contact lens: contact lenses.
Vision Stability While Doing Tasks on Mobile Phone	88.37 units on a scale Standard Deviation 10.71	85.30 units on a scale Standard Deviation 11.75

PRIMARY outcome

Timeframe: 30 minutes

Vision stability was assessed by study subjects while doing tasks on desktop using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss)

Outcome measures

Outcome measures
Measure	Test Contact Lens n=27 Participants Subjects were randomized to wear test lenses for 30 minutes. Test Contact lens: contact lenses.	Control Contact Lens n=27 Participants Subjects were randomized to wear control lenses for 30 minutes. Control Contact lens: contact lenses.
Vision Stability While Doing Tasks on Desktop	87.78 units on a scale Standard Deviation 12.04	83.41 units on a scale Standard Deviation 15.13

PRIMARY outcome

Timeframe: 30 minutes

Vision stability was assessed by study subjects while walking using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss)

Outcome measures

Outcome measures
Measure	Test Contact Lens n=27 Participants Subjects were randomized to wear test lenses for 30 minutes. Test Contact lens: contact lenses.	Control Contact Lens n=27 Participants Subjects were randomized to wear control lenses for 30 minutes. Control Contact lens: contact lenses.
Vision Stability While Walking	88.15 units on a scale Standard Deviation 14.77	82.63 units on a scale Standard Deviation 15.22

SECONDARY outcome

Timeframe: 10 minutes

Lens fit was assessed for lens rotation after 10 minutes for toric fit. Lens mislocation from optimal position was measured in 0°, 1-5°, 6-10°, 11-15°, 16-20°, More than 20°.

Outcome measures

Outcome measures
Measure	Test Contact Lens n=27 Participants Subjects were randomized to wear test lenses for 30 minutes. Test Contact lens: contact lenses.	Control Contact Lens n=27 Participants Subjects were randomized to wear control lenses for 30 minutes. Control Contact lens: contact lenses.
Lens Fit for Test Contact Lens 0°	8 Number of Lenses	9 Number of Lenses
Lens Fit for Test Contact Lens 1-5°	16 Number of Lenses	17 Number of Lenses
Lens Fit for Test Contact Lens 6-10°	2 Number of Lenses	0 Number of Lenses
Lens Fit for Test Contact Lens 11-15°	1 Number of Lenses	1 Number of Lenses
Lens Fit for Test Contact Lens 16-20°	0 Number of Lenses	0 Number of Lenses
Lens Fit for Test Contact Lens More than 20°	0 Number of Lenses	0 Number of Lenses

SECONDARY outcome

Timeframe: 30 minutes

Lens fit was assessed as either 'acceptable' or 'not acceptable' for standard fit by study investigator.

Outcome measures

Outcome measures
Measure	Test Contact Lens n=27 Participants Subjects were randomized to wear test lenses for 30 minutes. Test Contact lens: contact lenses.	Control Contact Lens n=27 Participants Subjects were randomized to wear control lenses for 30 minutes. Control Contact lens: contact lenses.
Lens Fit Acceptable	27 participants	27 participants
Lens Fit Not Acceptable	0 participants	0 participants

Adverse Events

Test Contact Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Contact 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

Jose A. Vega, O.D, MSc., FAAO

CooperVision. Inc

Phone: 9256213761

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place