Trial Outcomes & Findings for Comparing Silicone Hydrogel Contact Lens Wearers to Hydrogel Contact Lens Wearers and Non-lens Wearers (NCT NCT04886479)
NCT ID: NCT04886479
Last Updated: 2024-01-30
Results Overview
Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of limbal redness after 6-8 hours of habitual device wear. For each participant, measurements were taken for both eyes (OD - right eye, OS - left eye) at two locations (T - temporal, N - nasal).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
6-8 hours of habitual wear
Results posted on
2024-01-30
Participant Flow
Twenty-six participants were screened, with 3 of these not meeting all eligibility criteria and were considered screen failures. One participant withdrew for reasons unrelated to the study. These participants were not included in the total number of participants enrolled.
Unit of analysis: Eyes [single]
Participant milestones
| Measure |
DDSH Lens Wearers
Participants wore habitual DDSH Lens in both eyes for 6-8 hours (Period 1, observational). Afterwards, participants wore the Test Lens in one randomized eye that was kept closed and patched for 3 hours (Period 2, interventional).
|
DDH Lens Wearers
Participants wore habitual DDH Lens in both eyes for 6-8 hours (Period 1, observational). Afterwards, participants wore the Test Lens in one randomized eye that was kept closed and patched for 3 hours (Period 2, interventional).
|
Non-lens Wearers
Participants had no previous history of contact lens wear. Participants wore habitual spectacles, if any, for 6-8 hours (Period 1, observational). They did not receive the Test Lens and were not involved in Period 2.
|
|---|---|---|---|
|
Period 1: Habitual Device, 6-8 Hours
STARTED
|
10 20
|
3 6
|
9 18
|
|
Period 1: Habitual Device, 6-8 Hours
COMPLETED
|
10 20
|
3 6
|
9 18
|
|
Period 1: Habitual Device, 6-8 Hours
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
|
Period 2: Test Lens, 3 Hours
STARTED
|
10 10
|
3 3
|
0 0
|
|
Period 2: Test Lens, 3 Hours
COMPLETED
|
10 10
|
3 3
|
0 0
|
|
Period 2: Test Lens, 3 Hours
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing Silicone Hydrogel Contact Lens Wearers to Hydrogel Contact Lens Wearers and Non-lens Wearers
Baseline characteristics by cohort
| Measure |
DDSH Lens Wearers
n=10 Participants
Participants who habitually wear DDSH lenses
|
DDH Lens Wearers
n=3 Participants
Participants who habitually wear DDH lenses
|
Non-lens Wearers
n=9 Participants
Participants that do not wear either DDSH or DDH Lens.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
32.7 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
30.0 years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
31.7 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
31.9 years
STANDARD_DEVIATION 12.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Asian
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6-8 hours of habitual wearObjective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of limbal redness after 6-8 hours of habitual device wear. For each participant, measurements were taken for both eyes (OD - right eye, OS - left eye) at two locations (T - temporal, N - nasal).
Outcome measures
| Measure |
DDSH Lens Wearers
n=20 Eyes (single)
Participants wore habitual DDSH Lens in both eyes
|
DDH Lens Wearers
n=6 Eyes (single)
Participants wore habitual DDH Lens in both eyes
|
Non-lens Wearers
n=18 Eyes (single)
Participants did not wear either DDSH or DDH Lens
|
|---|---|---|---|
|
Limbal Redness - DDSH, DDH, Non-lens Groups
OD, T
|
0.41 score on a scale
Interval 0.24 to 0.58
|
0.37 score on a scale
Interval 0.05 to 0.68
|
0.44 score on a scale
Interval 0.26 to 0.63
|
|
Limbal Redness - DDSH, DDH, Non-lens Groups
OD, N
|
0.49 score on a scale
Interval 0.25 to 0.73
|
0.40 score on a scale
Interval -0.04 to 0.84
|
0.44 score on a scale
Interval 0.19 to 0.7
|
|
Limbal Redness - DDSH, DDH, Non-lens Groups
OS, T
|
0.54 score on a scale
Interval 0.35 to 0.73
|
0.30 score on a scale
Interval -0.05 to 0.65
|
0.46 score on a scale
Interval 0.25 to 0.66
|
|
Limbal Redness - DDSH, DDH, Non-lens Groups
OS, N
|
0.32 score on a scale
Interval 0.18 to 0.46
|
0.37 score on a scale
Interval 0.12 to 0.62
|
0.41 score on a scale
Interval 0.27 to 0.56
|
PRIMARY outcome
Timeframe: 6-8 hours of habitual wearObjective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of bulbar redness after 6-8 hours of habitual device wear. For each participant, measurements were taken for both eyes (OD - right eye, OS - left eye) at two locations (T - temporal, N - nasal).
Outcome measures
| Measure |
DDSH Lens Wearers
n=20 Eyes (single)
Participants wore habitual DDSH Lens in both eyes
|
DDH Lens Wearers
n=6 Eyes (single)
Participants wore habitual DDH Lens in both eyes
|
Non-lens Wearers
n=18 Eyes (single)
Participants did not wear either DDSH or DDH Lens
|
|---|---|---|---|
|
Bulbar Redness DDSH, DDH, Non-lens Groups
OD, T
|
0.76 score on a scale
Interval 0.55 to 0.97
|
0.67 score on a scale
Interval 0.28 to 1.05
|
0.79 score on a scale
Interval 0.56 to 1.01
|
|
Bulbar Redness DDSH, DDH, Non-lens Groups
OD, N
|
0.86 score on a scale
Interval 0.59 to 1.13
|
0.83 score on a scale
Interval 0.33 to 1.33
|
0.71 score on a scale
Interval 0.42 to 1.0
|
|
Bulbar Redness DDSH, DDH, Non-lens Groups
OS, T
|
0.93 score on a scale
Interval 0.63 to 1.23
|
0.73 score on a scale
Interval 0.18 to 1.28
|
0.80 score on a scale
Interval 0.48 to 1.12
|
|
Bulbar Redness DDSH, DDH, Non-lens Groups
OS, N
|
0.86 score on a scale
Interval 0.6 to 1.12
|
0.60 score on a scale
Interval 0.13 to 1.07
|
0.67 score on a scale
Interval 0.4 to 0.94
|
PRIMARY outcome
Timeframe: 6-8 hours of habitual wearNumber of participants with limbal vessel ingrowth longer than 0.50 mm at any of the 4 corneal quadrants (superior, inferior, nasal, temporal) after 6-8 hours of device wear.
Outcome measures
| Measure |
DDSH Lens Wearers
n=10 Participants
Participants wore habitual DDSH Lens in both eyes
|
DDH Lens Wearers
n=3 Participants
Participants wore habitual DDH Lens in both eyes
|
Non-lens Wearers
n=9 Participants
Participants did not wear either DDSH or DDH Lens
|
|---|---|---|---|
|
Limbal Vessel Ingrowth - DDSH, DDH, Non-lens Groups
|
2 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Immediately upon eye opening (t=baseline) and lens removal (t=0), 1 hour (t=1), and 3 hours (t=3) post lens removalObjective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of limbal redness by location (T - temporal, N - nasal) and time (t). Measurements were taken at baseline and over a 3 hour period of closed-eye Test Lens wear.
Outcome measures
| Measure |
DDSH Lens Wearers
n=10 Eyes (single)
Participants wore habitual DDSH Lens in both eyes
|
DDH Lens Wearers
n=3 Eyes (single)
Participants wore habitual DDH Lens in both eyes
|
Non-lens Wearers
Participants did not wear either DDSH or DDH Lens
|
|---|---|---|---|
|
Limbal Redness - DDSH, DDH Groups
T, t=baseline
|
0.48 score on a scale
Interval 0.28 to 0.68
|
0.33 score on a scale
Interval -0.04 to 0.71
|
—
|
|
Limbal Redness - DDSH, DDH Groups
T, t=0 hour
|
0.70 score on a scale
Interval 0.5 to 0.9
|
0.43 score on a scale
Interval 0.07 to 0.79
|
—
|
|
Limbal Redness - DDSH, DDH Groups
T, t=1 hours
|
0.61 score on a scale
Interval 0.36 to 0.86
|
0.43 score on a scale
Interval -0.03 to 0.9
|
—
|
|
Limbal Redness - DDSH, DDH Groups
T, t=3 hours
|
0.71 score on a scale
Interval 0.45 to 0.97
|
0.30 score on a scale
Interval -0.17 to 0.77
|
—
|
|
Limbal Redness - DDSH, DDH Groups
N, t=baseline
|
0.36 score on a scale
Interval 0.16 to 0.56
|
0.50 score on a scale
Interval 0.13 to 0.87
|
—
|
|
Limbal Redness - DDSH, DDH Groups
N, t=0 hour
|
0.72 score on a scale
Interval 0.44 to 1.0
|
0.63 score on a scale
Interval 0.11 to 1.15
|
—
|
|
Limbal Redness - DDSH, DDH Groups
N, t=1 hours
|
0.57 score on a scale
Interval 0.33 to 0.81
|
0.57 score on a scale
Interval 0.13 to 1.01
|
—
|
|
Limbal Redness - DDSH, DDH Groups
N, t=3 hours
|
0.63 score on a scale
Interval 0.34 to 0.92
|
0.43 score on a scale
Interval -0.1 to 0.97
|
—
|
PRIMARY outcome
Timeframe: Immediately upon eye opening (baseline) and lens removal (t=0), 1 hour (t=1), and 3 hours (t=3) post lens removalObjective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of bulbar redness by location (T - temporal, N - nasal) and time (t). Measurements were taken at baseline and over a 3 hour period of closed-eye Test Lens wear.
Outcome measures
| Measure |
DDSH Lens Wearers
n=10 Eyes (single)
Participants wore habitual DDSH Lens in both eyes
|
DDH Lens Wearers
n=3 Eyes (single)
Participants wore habitual DDH Lens in both eyes
|
Non-lens Wearers
Participants did not wear either DDSH or DDH Lens
|
|---|---|---|---|
|
Bulbar Redness - DDSH, DDH Groups
T, t=baseline
|
0.87 score on a scale
Interval 0.55 to 1.19
|
0.60 score on a scale
Interval 0.02 to 1.18
|
—
|
|
Bulbar Redness - DDSH, DDH Groups
T, t=0 hour
|
1.00 score on a scale
Interval 0.73 to 1.27
|
0.63 score on a scale
Interval 0.14 to 1.12
|
—
|
|
Bulbar Redness - DDSH, DDH Groups
T, t=1 hours
|
0.89 score on a scale
Interval 0.51 to 1.27
|
0.57 score on a scale
Interval -0.12 to 1.25
|
—
|
|
Bulbar Redness - DDSH, DDH Groups
T, t=3 hours
|
1.03 score on a scale
Interval 0.69 to 1.37
|
0.60 score on a scale
Interval -0.03 to 1.23
|
—
|
|
Bulbar Redness - DDSH, DDH Groups
N, t=baseline
|
0.78 score on a scale
Interval 0.47 to 1.09
|
0.80 score on a scale
Interval 0.23 to 1.37
|
—
|
|
Bulbar Redness - DDSH, DDH Groups
N, t=0 hour
|
1.14 score on a scale
Interval 0.87 to 1.41
|
0.87 score on a scale
Interval 0.37 to 1.36
|
—
|
|
Bulbar Redness - DDSH, DDH Groups
N, t=1 hours
|
1.00 score on a scale
Interval 0.73 to 1.27
|
0.73 score on a scale
Interval 0.24 to 1.23
|
—
|
|
Bulbar Redness - DDSH, DDH Groups
N, t=3 hours
|
1.21 score on a scale
Interval 0.81 to 1.61
|
0.77 score on a scale
Interval 0.03 to 1.5
|
—
|
SECONDARY outcome
Timeframe: Immediately upon eye opening and lens removal (t=0), 0.5 hours (t=0.5), 1 hour (t=1), 2 hours (t=2), and 3 hours (t=3) post lens removalDifference in central corneal swelling (μm, Visante OCT) at baseline (before lens insertion) vs. measurements taken over a 3 hour period following Test Lens removal. Derived by the formula: corneal swelling % = (measured corneal thickness - baseline corneal thickness) x 100 /baseline corneal thickness.
Outcome measures
| Measure |
DDSH Lens Wearers
n=10 Eyes (single)
Participants wore habitual DDSH Lens in both eyes
|
DDH Lens Wearers
n=3 Eyes (single)
Participants wore habitual DDH Lens in both eyes
|
Non-lens Wearers
Participants did not wear either DDSH or DDH Lens
|
|---|---|---|---|
|
Central Corneal Swelling (%) - DDSH, DDH Groups
t=0 hours
|
9.67 Percent change in corneal swelling (%)
Interval 7.28 to 12.07
|
9.34 Percent change in corneal swelling (%)
Interval 4.97 to 13.71
|
—
|
|
Central Corneal Swelling (%) - DDSH, DDH Groups
t=0.5 hours
|
7.68 Percent change in corneal swelling (%)
Interval 5.61 to 9.75
|
6.82 Percent change in corneal swelling (%)
Interval 3.03 to 10.6
|
—
|
|
Central Corneal Swelling (%) - DDSH, DDH Groups
t=1 hour
|
5.17 Percent change in corneal swelling (%)
Interval 3.57 to 6.76
|
4.26 Percent change in corneal swelling (%)
Interval 1.35 to 7.17
|
—
|
|
Central Corneal Swelling (%) - DDSH, DDH Groups
t=2 hours
|
0.98 Percent change in corneal swelling (%)
Interval 0.2 to 1.77
|
0.45 Percent change in corneal swelling (%)
Interval -0.99 to 1.88
|
—
|
|
Central Corneal Swelling (%) - DDSH, DDH Groups
t=3 hours
|
-0.41 Percent change in corneal swelling (%)
Interval -1.15 to 0.32
|
-0.45 Percent change in corneal swelling (%)
Interval -1.8 to 0.89
|
—
|
Adverse Events
DDSH Lens Wearers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DDH Lens Wearers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-lens Wearers
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 |
DDSH Lens Wearers
n=10 participants at risk
Participants that wore DDSH Lens in Period 1 and Test Lens in Period 2
|
DDH Lens Wearers
n=3 participants at risk
Participants that wore DDH Lens in Period 1 and Test Lens in Period 2
|
Non-lens Wearers
n=9 participants at risk
Participants that did not wear DDSH or DDH Lenses in Period 1
|
|---|---|---|---|
|
Eye disorders
Lightheadedness
|
0.00%
0/10 • Through study exit, up to 30 days from the first visit.
|
0.00%
0/3 • Through study exit, up to 30 days from the first visit.
|
11.1%
1/9 • Number of events 1 • Through study exit, up to 30 days from the first visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place