Trial Outcomes & Findings for 1 Week Crossover Study Between Two Soft Contact Lenses (NCT NCT06611410)

NCT ID: NCT06611410

Last Updated: 2025-10-15

Results Overview

High contrast, binocular, distance visual acuity (logMAR) will be measured at 1-week visit.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: At the end of one week wear
• Results posted on: 2025-10-15

Participant Flow

Ten participants were enrolled in the study. One participant was excluded due to screening failure. (n=9)

Participant milestones

Measure	Test Lenses First, Then Control Lenses Participants wore the Test Lenses in both eyes for one week and then crossed over to the Control Lenses in both eyes for one week.	Control Lenses First, Then Test Lenses Participants wore the Control Lenses in both eyes for one week and then crossed over to the Test Lenses in both eyes for one week.
(Period 1): First Intervention (7 Days) STARTED	4	5
(Period 1): First Intervention (7 Days) COMPLETED	4	5
(Period 1): First Intervention (7 Days) NOT COMPLETED	0	0
(Period 2): Second Intervention (7 Days) STARTED	4	5
(Period 2): Second Intervention (7 Days) COMPLETED	4	5
(Period 2): Second Intervention (7 Days) 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

Measure	Overall Study n=8 Participants Total eight participants were analyzed who completed all study visits. (One participant was excluded from the analysis due to protocol deviation)
Age, Categorical <=18 years	8 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=8 Participants
Sex: Female, Male Female	6 Participants n=8 Participants
Sex: Female, Male Male	2 Participants n=8 Participants

PRIMARY outcome

Timeframe: At the end of one week wear

Population: Analysis population includes all the participants who completed all the study visits.

High contrast, binocular, distance visual acuity (logMAR) will be measured at 1-week visit.

Outcome measures

Measure	Test Lenses (Stenfilcon A) n=8 Participants Participants that received the Test Lenses and completed all study visits	Control Lenses (Omafilcon A) n=8 Participants Participants that received the Control Lenses and completed all study visits
High Contrast, Binocular, Distance Visual Acuity (logMAR)	-0.15 logMAR Standard Deviation 0.03	-0.15 logMAR Standard Deviation 0.05

SECONDARY outcome

Timeframe: At the end of one week wear

Subjective vision quality on 0-100 Visual Analog Scale (where, 0=very poor and 100=very good)

Outcome measures

Measure	Test Lenses (Stenfilcon A) n=8 Participants Participants that received the Test Lenses and completed all study visits	Control Lenses (Omafilcon A) n=8 Participants Participants that received the Control Lenses and completed all study visits
Subjective Vision Quality	94.12 units on a scale Standard Deviation 4.67	87.12 units on a scale Standard Deviation 11.61

Adverse Events

Test Lenses (Stenfilcon A)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control Lenses (Omafilcon A)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Test Lenses (Stenfilcon A) n=9 participants at risk All participants that received the Test Lenses	Control Lenses (Omafilcon A) n=9 participants at risk All participants that received the Control Lenses
Eye disorders Viral Conjuctivitis	11.1% 1/9 • Number of events 1 • Duration study, approximately 20 days.	0.00% 0/9 • Duration study, approximately 20 days.
General disorders Lightheaded	0.00% 0/9 • Duration study, approximately 20 days.	11.1% 1/9 • Number of events 1 • Duration study, approximately 20 days.

Additional Information

Lee Hall

CooperVision

Phone: +19256604365

Email: LHall@coopervision.com

Results disclosure agreements

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

Restriction type: OTHER