Trial Outcomes & Findings for Evaluation of Contact Lenses and Conjunctival Staining in Normal Patients (NCT NCT00799422)
NCT ID: NCT00799422
Last Updated: 2012-11-16
Results Overview
Circumlimbal conjunctival staining was expressed as the sum of the individual scores observed across all of the evaluated regions of the eye. The bulbar conjunctiva was assessed by the investigator utilizing a slit-lamp and lissamine green ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 4-point clinical grading scale (grade 0-3), where Grade 0 = No staining present; Grade 1 = Slight staining present; Grade 2 = Moderate staining present; and Grade 3 = Dense staining present. The scores for the four regions were summed, with a sum score range of 0-12. A lower score represents a more desirable outcome.
COMPLETED
NA
26 participants
1 week
2012-11-16
Participant Flow
In this 3-treatment, 3-period, 6-sequence crossover study, each subject received all 3 products in randomized order and used 1 product at a time for a duration of 1 week before switching to the next assigned product. A 36-hour washout preceded each usage period.
Participant milestones
| Measure |
ReNu / Complete / Clear Care
ReNu Multiplus, then Complete Easy Rub, then Clear Care, 1 week each
|
Complete / Clear Care / ReNu
Complete Easy Rub, then Clear Care, then ReNu MultiPlus, 1 week each
|
Clear Care / ReNu / Complete
Clear Care, then ReNu MultiPlus, then Complete Easy Rub, 1 week each
|
ReNu / Clear Care / Complete
ReNu MultiPlus, then Clear Care, then Complete Easy Rub, 1 week each
|
Complete / ReNu / Clear Care
Complete Easy Rub, then ReNu MultiPlus), then Clear Care, 1 week each
|
Clear Care / Complete / ReNu
Clear Care, then Complete Easy Rub, then ReNu MultiPlus, 1 week each
|
|---|---|---|---|---|---|---|
|
First Week of Wear
STARTED
|
4
|
4
|
4
|
5
|
4
|
5
|
|
First Week of Wear
COMPLETED
|
4
|
4
|
3
|
4
|
4
|
5
|
|
First Week of Wear
NOT COMPLETED
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Second Week of Wear
STARTED
|
4
|
4
|
3
|
3
|
4
|
4
|
|
Second Week of Wear
COMPLETED
|
4
|
4
|
3
|
3
|
4
|
4
|
|
Second Week of Wear
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Week of Wear
STARTED
|
4
|
4
|
3
|
3
|
4
|
4
|
|
Third Week of Wear
COMPLETED
|
4
|
4
|
3
|
3
|
4
|
4
|
|
Third Week of Wear
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
ReNu / Complete / Clear Care
ReNu Multiplus, then Complete Easy Rub, then Clear Care, 1 week each
|
Complete / Clear Care / ReNu
Complete Easy Rub, then Clear Care, then ReNu MultiPlus, 1 week each
|
Clear Care / ReNu / Complete
Clear Care, then ReNu MultiPlus, then Complete Easy Rub, 1 week each
|
ReNu / Clear Care / Complete
ReNu MultiPlus, then Clear Care, then Complete Easy Rub, 1 week each
|
Complete / ReNu / Clear Care
Complete Easy Rub, then ReNu MultiPlus), then Clear Care, 1 week each
|
Clear Care / Complete / ReNu
Clear Care, then Complete Easy Rub, then ReNu MultiPlus, 1 week each
|
|---|---|---|---|---|---|---|
|
First Week of Wear
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
|
First Week of Wear
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Evaluation of Contact Lenses and Conjunctival Staining in Normal Patients
Baseline characteristics by cohort
| Measure |
Overall
n=22 Participants
Baseline characteristics are presented for all participants completing all three treatment sequences.
|
|---|---|
|
Age Continuous
|
41.6 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 weekPopulation: This reporting group includes all participants who completed all study visits.
Circumlimbal conjunctival staining was expressed as the sum of the individual scores observed across all of the evaluated regions of the eye. The bulbar conjunctiva was assessed by the investigator utilizing a slit-lamp and lissamine green ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 4-point clinical grading scale (grade 0-3), where Grade 0 = No staining present; Grade 1 = Slight staining present; Grade 2 = Moderate staining present; and Grade 3 = Dense staining present. The scores for the four regions were summed, with a sum score range of 0-12. A lower score represents a more desirable outcome.
Outcome measures
| Measure |
ReNu MultiPlus
n=22 Participants
ReNu MultiPlus used for one week as specified in the protocol with study contact lenses.
|
Complete Easy Rub
n=22 Participants
Complete Easy Rub used for one week as specified in the protocol with study contact lenses.
|
Clear Care
n=22 Participants
Clear Care used for one week as specified in the protocol with study contact lenses.
|
|---|---|---|---|
|
Mean Circumlimbal Conjunctival Staining Score
|
6.39 Units on a scale
Standard Deviation 2.30
|
5.55 Units on a scale
Standard Deviation 2.94
|
5.68 Units on a scale
Standard Deviation 1.91
|
SECONDARY outcome
Timeframe: Dispense (Day 0), 1 weekPopulation: This reporting group includes all participants who completed all study visits.
Lens base curve at dispense was as listed on product label: 8.4 millimeters (mm). Lens base curve at 1 week was as measured after lens removal. A negative number represented a steepening of the base curve.
Outcome measures
| Measure |
ReNu MultiPlus
n=22 Participants
ReNu MultiPlus used for one week as specified in the protocol with study contact lenses.
|
Complete Easy Rub
n=22 Participants
Complete Easy Rub used for one week as specified in the protocol with study contact lenses.
|
Clear Care
n=22 Participants
Clear Care used for one week as specified in the protocol with study contact lenses.
|
|---|---|---|---|
|
Mean Change From Dispense (Day 0) in Lens Base Curve at 1 Week
|
-0.25 mm
Standard Deviation 0.16
|
-0.27 mm
Standard Deviation 0.17
|
-0.25 mm
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: Dispense (Day 0), 1 weekPopulation: This reporting group includes all participants who completed all study visits.
Lens diameter at dispense was as listed on product label: 14.0 mm. Lens diameter at 1 week was as measured after lens removal. A positive number indicated a widening of lens diameter.
Outcome measures
| Measure |
ReNu MultiPlus
n=22 Participants
ReNu MultiPlus used for one week as specified in the protocol with study contact lenses.
|
Complete Easy Rub
n=22 Participants
Complete Easy Rub used for one week as specified in the protocol with study contact lenses.
|
Clear Care
n=22 Participants
Clear Care used for one week as specified in the protocol with study contact lenses.
|
|---|---|---|---|
|
Mean Change From Dispense (Day 0) in Lens Diameter at 1 Week
|
0.15 mm
Standard Deviation 0.10
|
0.13 mm
Standard Deviation 0.11
|
0.14 mm
Standard Deviation 0.10
|
Adverse Events
ReNu MultiPlus
Complete Easy Rub
Clear Care
Serious adverse events
| Measure |
ReNu MultiPlus
n=22 participants at risk
ReNu MultiPlus used for one week as specified in the protocol with study contact lenses.
|
Complete Easy Rub
n=22 participants at risk
Complete Easy Rub used for one week as specified in the protocol with study contact lenses.
|
Clear Care
n=22 participants at risk
Clear Care used for one week as specified in the protocol with study contact lenses.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.5%
1/22 • Adverse events were collected for the duration of the study.
This reporting group includes all enrolled and exposed participants.
|
0.00%
0/22 • Adverse events were collected for the duration of the study.
This reporting group includes all enrolled and exposed participants.
|
0.00%
0/22 • Adverse events were collected for the duration of the study.
This reporting group includes all enrolled and exposed participants.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place