Trial Outcomes & Findings for Clinical Evaluation of Hydrogel and Silicone Hydrogel Daily Disposable Toric Contact Lenses (NCT NCT05805085)

Results Overview

Subjective handling an lens insertion was assessed at the dispending visit using a 0-100 scale, where 100=Excellent, very easy; 0=Very difficult to manage. Collected once at the end of 15 minutes of wear.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

15 minutes

Results posted on

2024-12-12

Participant Flow

Participant milestones

Participant milestones
Measure	Lens A All participants wore Lens A for 15 minutes (Period 1)	Lens B All participants wore Lens B for 15 minutes (Period 2)
Period 1: Lens A, 15 Minutes STARTED	40	0
Period 1: Lens A, 15 Minutes COMPLETED	40	0
Period 1: Lens A, 15 Minutes NOT COMPLETED	0	0
Period 2: Lens B, 15 Minutes STARTED	0	40
Period 2: Lens B, 15 Minutes COMPLETED	0	40
Period 2: Lens B, 15 Minutes NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age was stratified by sex (Male and Female)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=40 Participants Includes study participants that completed all study visits
Age, Continuous Male	27.10 years STANDARD_DEVIATION 6.04 • n=13 Participants • Age was stratified by sex (Male and Female)
Age, Continuous Female	27.08 years STANDARD_DEVIATION 6.17 • n=27 Participants • Age was stratified by sex (Male and Female)
Sex: Female, Male Female	27 Participants n=40 Participants
Sex: Female, Male Male	13 Participants n=40 Participants

PRIMARY outcome

Timeframe: 15 minutes

Subjective handling an lens insertion was assessed at the dispending visit using a 0-100 scale, where 100=Excellent, very easy; 0=Very difficult to manage. Collected once at the end of 15 minutes of wear.

Outcome measures

Outcome measures
Measure	Lens A n=40 Participants Participants that received Lens A	Lens B n=40 Participants Participants that received Lens B
Subjective Handling at Insertion, Dispensing Visit	87.13 score on a scale Standard Deviation 13.68	88.50 score on a scale Standard Deviation 10.14

PRIMARY outcome

Timeframe: 15 minutes

Subjective handling at lens insertion was assessed at the follow-up visit using a 0-100 scale, where 100=Excellent, very easy; 0=Very difficult to manage. Collected once at the end of 15 minutes of wear.

Outcome measures

Outcome measures
Measure	Lens A n=40 Participants Participants that received Lens A	Lens B n=40 Participants Participants that received Lens B
Subjecting Handling at Insertion, Follow-up Visit	92.63 score on a scale Standard Deviation 9.28	90.13 score on a scale Standard Deviation 9.97

Adverse Events

Lens A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lens B

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

José A. Vega OD, MSc, PhD, FAAO

CooperVision Inc.

Phone: +19256213761

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place