Trial Outcomes & Findings for An Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues (NCT NCT01594294)
NCT ID: NCT01594294
Last Updated: 2014-07-25
Results Overview
Eyelid papillae (bumps on the inner eyelid) were recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale: 0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse \& tufts papillae); 3 = Moderate (moderate \& tufts papillae); 4 = Severe (giant papillae). The maximum value represents the worse grade in any zone. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.
COMPLETED
NA
100 participants
Baseline (Day 0), Month 3
2014-07-25
Participant Flow
Of the 100 participants enrolled, 21 were exited as screen failures prior to initiation of the Investigational Phase. This reporting group includes all participants randomized into the Investigational Phase (79).
Participant milestones
| Measure |
AOSEPT Plus
AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
|
ReNu MultiPlus
ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
40
|
|
Overall Study
COMPLETED
|
36
|
36
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues
Baseline characteristics by cohort
| Measure |
AOSEPT Plus
n=35 Participants
AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
|
ReNu MultiPlus
n=36 Participants
ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.7 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
37.1 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
36.4 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0), Month 3Population: This analysis population includes all participants who completed the study as per the protocol, minus missing responses.
Eyelid papillae (bumps on the inner eyelid) were recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale: 0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse \& tufts papillae); 3 = Moderate (moderate \& tufts papillae); 4 = Severe (giant papillae). The maximum value represents the worse grade in any zone. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.
Outcome measures
| Measure |
AOSEPT Plus
n=68 Eyes
AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
|
ReNu MultiPlus
n=71 Eyes
ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
|
|---|---|---|
|
Maximum Papillae
Baseline (Day 0)
|
1.50 Units on a scale
Interval 0.5 to 3.0
|
1.00 Units on a scale
Interval 0.0 to 3.0
|
|
Maximum Papillae
Month 3
|
1.50 Units on a scale
Interval 0.5 to 3.0
|
1.00 Units on a scale
Interval 0.0 to 3.0
|
PRIMARY outcome
Timeframe: Baseline (Day 0), Month 3Population: This analysis population includes all participants who completed the study as per the protocol, minus missing responses.
Eyelid hyperaemia (redness) was recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale: 0 = Clear; 1 = Slight redness; 2 = Mild redness; 3 = Moderate redness; 4 = Severe redness). The maximum value represents the worst grade in any zone. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.
Outcome measures
| Measure |
AOSEPT Plus
n=68 Eyes
AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
|
ReNu MultiPlus
n=71 Eyes
ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
|
|---|---|---|
|
Maximum Eyelid Hyperaemia
Baseline (Day 0)
|
2.00 units on a scale
Interval 1.0 to 3.0
|
2.00 units on a scale
Interval 1.0 to 3.5
|
|
Maximum Eyelid Hyperaemia
Month 3
|
2.00 units on a scale
Interval 1.5 to 4.0
|
2.00 units on a scale
Interval 1.0 to 3.0
|
PRIMARY outcome
Timeframe: Baseline (Day 0), Month 3Population: This analysis population includes all participants who completed the study as per the protocol, minus missing responses.
The contact lenses were removed and upper eyelid redness was objectively measured through digital images. The coverage of the palpebral surface by blood vessels is expressed as percentage of the total surface measured. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.
Outcome measures
| Measure |
AOSEPT Plus
n=68 Eyes
AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
|
ReNu MultiPlus
n=71 Eyes
ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
|
|---|---|---|
|
Mean Upper Eyelid Redness
Baseline (Day 0)
|
34.7 percentage of total surface measured
Standard Deviation 15.5
|
31.9 percentage of total surface measured
Standard Deviation 9.1
|
|
Mean Upper Eyelid Redness
Month 3
|
33.4 percentage of total surface measured
Standard Deviation 13.4
|
30.8 percentage of total surface measured
Standard Deviation 12.7
|
PRIMARY outcome
Timeframe: Baseline (Day 0), Month 3Population: This analysis population includes all participants who completed the study as per the protocol, minus missing responses.
The contact lens was removed and ophthalmic dye was instilled. Upper eyelid margin staining was objectively measured through digital images. The extent of true staining (i.e., the total area of lid margin covered by staining) was recorded. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.
Outcome measures
| Measure |
AOSEPT Plus
n=68 Eyes
AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
|
ReNu MultiPlus
n=71 Eyes
ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
|
|---|---|---|
|
Mean Upper Eyelid Margin Staining
Baseline (Day 0)
|
5.36 square millimeters
Standard Deviation 4.21
|
4.33 square millimeters
Standard Deviation 2.65
|
|
Mean Upper Eyelid Margin Staining
Month 3
|
4.49 square millimeters
Standard Deviation 2.90
|
4.80 square millimeters
Standard Deviation 2.82
|
SECONDARY outcome
Timeframe: Month 3Population: This analysis population includes all participants who completed the study as per the protocol, minus missing responses.
The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eyelid and the contact lens). The time required for a dry spot to appear on the pre-lens surface after blinking is referred to as the pre-lens tear film break up time. PL-NIBUT was evaluated using a biomicroscope with a diffuse illumination source, i.e., Tearscope. A longer PL-NIBUT indicates a more stable tear film and greater on-eye lens wettability. Three PL-NIBUT measurements were recorded, and the median value was used for analysis. Both eyes were included in the model for analysis. Contact lenses were on-eye for this assessment.
Outcome measures
| Measure |
AOSEPT Plus
n=68 Eyes
AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
|
ReNu MultiPlus
n=71 Eyes
ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
|
|---|---|---|
|
Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT)
|
4.16 seconds
Standard Deviation 3.50
|
4.52 seconds
Standard Deviation 3.46
|
Adverse Events
AOSEPT Plus
ReNu MultiPlus
Serious adverse events
| Measure |
AOSEPT Plus
n=39 participants at risk
AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
|
ReNu MultiPlus
n=39 participants at risk
ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall causing crack on the skull and internal bleeding
|
2.6%
1/39 • Adverse events were collected for the duration of the study (April 2012 to June 2013). An adverse event was any untoward medical occurrence in a subject administered a test article regardless of causal relationship with the treatment.
This analysis population includes all participants exposed to the test product during the Investigational Phase.
|
0.00%
0/39 • Adverse events were collected for the duration of the study (April 2012 to June 2013). An adverse event was any untoward medical occurrence in a subject administered a test article regardless of causal relationship with the treatment.
This analysis population includes all participants exposed to the test product during the Investigational Phase.
|
|
Surgical and medical procedures
Fibroids
|
2.6%
1/39 • Adverse events were collected for the duration of the study (April 2012 to June 2013). An adverse event was any untoward medical occurrence in a subject administered a test article regardless of causal relationship with the treatment.
This analysis population includes all participants exposed to the test product during the Investigational Phase.
|
0.00%
0/39 • Adverse events were collected for the duration of the study (April 2012 to June 2013). An adverse event was any untoward medical occurrence in a subject administered a test article regardless of causal relationship with the treatment.
This analysis population includes all participants exposed to the test product during the Investigational Phase.
|
|
Surgical and medical procedures
Hernia
|
0.00%
0/39 • Adverse events were collected for the duration of the study (April 2012 to June 2013). An adverse event was any untoward medical occurrence in a subject administered a test article regardless of causal relationship with the treatment.
This analysis population includes all participants exposed to the test product during the Investigational Phase.
|
2.6%
1/39 • Adverse events were collected for the duration of the study (April 2012 to June 2013). An adverse event was any untoward medical occurrence in a subject administered a test article regardless of causal relationship with the treatment.
This analysis population includes all participants exposed to the test product during the Investigational Phase.
|
|
Surgical and medical procedures
Dehydration and possible chest infection
|
0.00%
0/39 • Adverse events were collected for the duration of the study (April 2012 to June 2013). An adverse event was any untoward medical occurrence in a subject administered a test article regardless of causal relationship with the treatment.
This analysis population includes all participants exposed to the test product during the Investigational Phase.
|
2.6%
1/39 • Adverse events were collected for the duration of the study (April 2012 to June 2013). An adverse event was any untoward medical occurrence in a subject administered a test article regardless of causal relationship with the treatment.
This analysis population includes all participants exposed to the test product during the Investigational Phase.
|
Other adverse events
| Measure |
AOSEPT Plus
n=39 participants at risk
AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
|
ReNu MultiPlus
n=39 participants at risk
ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
|
|---|---|---|
|
Injury, poisoning and procedural complications
Toxic reaction
|
7.7%
3/39 • Adverse events were collected for the duration of the study (April 2012 to June 2013). An adverse event was any untoward medical occurrence in a subject administered a test article regardless of causal relationship with the treatment.
This analysis population includes all participants exposed to the test product during the Investigational Phase.
|
0.00%
0/39 • Adverse events were collected for the duration of the study (April 2012 to June 2013). An adverse event was any untoward medical occurrence in a subject administered a test article regardless of causal relationship with the treatment.
This analysis population includes all participants exposed to the test product during the Investigational Phase.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER