Trial Outcomes & Findings for Daytime Corneal Swelling During Wear of Narafilcon B Lenses (NCT NCT01444287)
NCT ID: NCT01444287
Last Updated: 2018-06-19
Results Overview
Percentage of corneal swelling (positive value) or deswelling (negative value) measured with Haag-Streit pachymetry equipment in microns, reported as a percent.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
After 8 hours of contact lens wear
Results posted on
2018-06-19
Participant Flow
There were 22 subjects enrolled to the study, all completed the four experimental sessions.
Participant milestones
| Measure |
All Study Participants
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations. The four arms were Spectacles (no contact lenses), Narafilcon B, Polymacon A, and Lotrafilcon A, in random order during the sessions.
|
|---|---|
|
Period 1
STARTED
|
22
|
|
Period 1
COMPLETED
|
22
|
|
Period 1
NOT COMPLETED
|
0
|
|
Period 2
STARTED
|
22
|
|
Period 2
COMPLETED
|
22
|
|
Period 2
NOT COMPLETED
|
0
|
|
Period 3
STARTED
|
22
|
|
Period 3
COMPLETED
|
22
|
|
Period 3
NOT COMPLETED
|
0
|
|
Period 4
STARTED
|
22
|
|
Period 4
COMPLETED
|
22
|
|
Period 4
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Daytime Corneal Swelling During Wear of Narafilcon B Lenses
Baseline characteristics by cohort
| Measure |
All Subjects
n=22 Participants
Subjects who were enrolled and randomized to a trial arm.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
30.8 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After 8 hours of contact lens wearPopulation: Subjects are those enrolled and randomized to a trial arm.
Percentage of corneal swelling (positive value) or deswelling (negative value) measured with Haag-Streit pachymetry equipment in microns, reported as a percent.
Outcome measures
| Measure |
Spectacles No Lenses
n=22 Participants
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
|
Narafilcon B
n=22 Participants
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
|
Polymacon
n=22 Participants
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
|
Lotrafilcon A
n=22 Participants
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
|
|---|---|---|---|---|
|
Corneal Thickness
|
-0.35 Percent Change
Standard Error 0.15
|
-0.99 Percent Change
Standard Error 0.18
|
0.75 Percent Change
Standard Error 0.21
|
-1.02 Percent Change
Standard Error 0.23
|
PRIMARY outcome
Timeframe: baseline, after 20 minutes of treatment conditionsCorneal images captured with equipment are measured, manually outlined to estimate total bleb area from 0 to 100%. This is measured as a change in percentage after 20 minutes compared to the value prior to lens wear (baseline).
Outcome measures
| Measure |
Spectacles No Lenses
n=22 Participants
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
|
Narafilcon B
n=22 Participants
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
|
Polymacon
n=22 Participants
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
|
Lotrafilcon A
n=22 Participants
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
|
|---|---|---|---|---|
|
Endothelial Blebs
|
-0.13 percentage of bleb area
Standard Error 0.31
|
0.49 percentage of bleb area
Standard Error 0.23
|
0.41 percentage of bleb area
Standard Error 0.40
|
0.38 percentage of bleb area
Standard Error 0.41
|
PRIMARY outcome
Timeframe: Baseline, After 8 hours of treatment conditionsScale of 0 to 4, where 0=none and 4= severe redness. Measure reported as a comparison of 8 hours of wear to baseline with the difference being reported.
Outcome measures
| Measure |
Spectacles No Lenses
n=22 Participants
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
|
Narafilcon B
n=22 Participants
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
|
Polymacon
n=22 Participants
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
|
Lotrafilcon A
n=22 Participants
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
|
|---|---|---|---|---|
|
Limbal Redness
|
-0.03 units on a scale
Standard Error 0.06
|
-0.04 units on a scale
Standard Error 0.5
|
0.64 units on a scale
Standard Error 0.10
|
0.13 units on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: after 8 hoursPatient reported subjective comfort of lenses or spectacles (range 0-100, where 100 is best).
Outcome measures
| Measure |
Spectacles No Lenses
n=22 Participants
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
|
Narafilcon B
n=22 Participants
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
|
Polymacon
n=22 Participants
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
|
Lotrafilcon A
n=22 Participants
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
|
|---|---|---|---|---|
|
Overall Comfort
|
96.0 units on a scale
Standard Error 1.3
|
96.1 units on a scale
Standard Error 1.0
|
78.3 units on a scale
Standard Error 5.1
|
80.7 units on a scale
Standard Error 4.4
|
Adverse Events
Spectacles No Lenses
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Narafilcon B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Polymacon A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lotrafilcon A
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60