Trial Outcomes & Findings for Performance Comparison of Two Monthly Replacement Silicone Hydrogel Multifocal Lens Types (NCT NCT06232590)
NCT ID: NCT06232590
Last Updated: 2025-02-12
Results Overview
Subjective rating collected in office using a 0-100 scale, where 0=Very difficult and 100=Very easy. The participant rated the study lens considering a typical day in the last 1 month of wear.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
1 month
Results posted on
2025-02-12
Participant Flow
Participant milestones
| Measure |
Control Lens, Then Test Lens
Participants wore the Control Lens for 1 month, then the Test Lens for 1 month
|
Test Lens, Then Control Lens
Participants wore the Test Lens for 1 month, then the Control Lens for 1 month
|
|---|---|---|
|
Period 1: First Intervention
STARTED
|
30
|
30
|
|
Period 1: First Intervention
COMPLETED
|
30
|
30
|
|
Period 1: First Intervention
NOT COMPLETED
|
0
|
0
|
|
Period 2: Second Intervention
STARTED
|
30
|
30
|
|
Period 2: Second Intervention
COMPLETED
|
29
|
30
|
|
Period 2: Second Intervention
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Control Lens, Then Test Lens
Participants wore the Control Lens for 1 month, then the Test Lens for 1 month
|
Test Lens, Then Control Lens
Participants wore the Test Lens for 1 month, then the Control Lens for 1 month
|
|---|---|---|
|
Period 2: Second Intervention
Unable to attend study visit
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Overall Study
n=59 Participants
Participants who completed all study visits.
|
|---|---|
|
Age, Continuous
|
53.2 years
STANDARD_DEVIATION 6.7 • n=59 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=59 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=59 Participants
|
PRIMARY outcome
Timeframe: 1 monthSubjective rating collected in office using a 0-100 scale, where 0=Very difficult and 100=Very easy. The participant rated the study lens considering a typical day in the last 1 month of wear.
Outcome measures
| Measure |
Control Lens
n=59 Participants
Participants that received the Control Lens and completed all study visits.
|
Test Lens
n=59 Participants
Participants that received the Test Lens and completed all study visits.
|
|---|---|---|
|
Lens Handling for Insertion
|
95 score on a scale
Standard Deviation 9
|
96 score on a scale
Standard Deviation 8
|
Adverse Events
Control Lens
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Test Lens
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control Lens
n=60 participants at risk
All participants that received the Control Lens.
|
Test Lens
n=59 participants at risk
All participants that received the Test Lens.
|
|---|---|---|
|
Eye disorders
Small lymph cysts
|
0.00%
0/60 • Length of study, approximately 3 months
|
1.7%
1/59 • Number of events 2 • Length of study, approximately 3 months
|
|
Eye disorders
Subconjunctival hemorrhage
|
1.7%
1/60 • Number of events 1 • Length of study, approximately 3 months
|
0.00%
0/59 • Length of study, approximately 3 months
|
|
Eye disorders
Eye floaters
|
0.00%
0/60 • Length of study, approximately 3 months
|
1.7%
1/59 • Number of events 1 • Length of study, approximately 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory infection
|
1.7%
1/60 • Number of events 1 • Length of study, approximately 3 months
|
1.7%
1/59 • Number of events 1 • Length of study, approximately 3 months
|
|
Gastrointestinal disorders
Stomach distress
|
0.00%
0/60 • Length of study, approximately 3 months
|
1.7%
1/59 • Number of events 1 • Length of study, approximately 3 months
|
|
Psychiatric disorders
Depression
|
1.7%
1/60 • Number of events 1 • Length of study, approximately 3 months
|
0.00%
0/59 • Length of study, approximately 3 months
|
|
Surgical and medical procedures
Primary care provider intervention
|
1.7%
1/60 • Number of events 1 • Length of study, approximately 3 months
|
0.00%
0/59 • Length of study, approximately 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place