Trial Outcomes & Findings for Clinical Biocompatibility Evaluation of Contact Lens Coatings (NCT NCT03034928)
NCT ID: NCT03034928
Last Updated: 2020-02-18
Results Overview
Percent of solution-related corneal staining area was assessed first in each of the 5 corneal regions: central, superior, nasal, inferior, and temporal. The average of corneal staining area was then calculated as the average over all 5 regions. A higher percentage reflects more damage to the corneal surface. Both eyes contributed to the analysis. No hypotheses were formulated; no inferences were made and only descriptive statistics were used in the reporting.
COMPLETED
NA
33 participants
Day 1 after 2 hours of wear, each product
2020-02-18
Participant Flow
Subjects were recruited from 1 study center located in the United States (US).
All 33 subjects enrolled were randomized. This reporting group includes all randomized subjects (33).
Participant milestones
| Measure |
Test 1/Control 1, Then Control 2/Test 2
Contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
|
Test 2/Control 2, Then Control 1/Test 1
Contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
|
Control 1/Test 1, Then Test 2/Control 2
Balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 1, followed by contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
|
Control 2/Test 2, Then Test 1/Control 1
Balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 1, followed by contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
|
|---|---|---|---|---|
|
Period 1, First 2 Hours of Wear
STARTED
|
8
|
8
|
9
|
8
|
|
Period 1, First 2 Hours of Wear
COMPLETED
|
8
|
8
|
9
|
8
|
|
Period 1, First 2 Hours of Wear
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period Between Lens Wear
STARTED
|
8
|
8
|
9
|
8
|
|
Washout Period Between Lens Wear
COMPLETED
|
8
|
8
|
9
|
8
|
|
Washout Period Between Lens Wear
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 2, Second 2 Hours of Wear
STARTED
|
8
|
8
|
9
|
8
|
|
Period 2, Second 2 Hours of Wear
COMPLETED
|
8
|
8
|
9
|
8
|
|
Period 2, Second 2 Hours of Wear
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Biocompatibility Evaluation of Contact Lens Coatings
Baseline characteristics by cohort
| Measure |
Overall
n=33 Participants
Contact lens with investigational coatings and balafilcon A contact lens worn contralaterally during Period 1 and Period 2.
|
|---|---|
|
Age, Continuous
|
46.9 years
STANDARD_DEVIATION 14.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multi-Racial
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 after 2 hours of wear, each productPopulation: This analysis population includes all randomized subjects who satisfied protocol-specified criteria (Full Analysis Set).
Percent of solution-related corneal staining area was assessed first in each of the 5 corneal regions: central, superior, nasal, inferior, and temporal. The average of corneal staining area was then calculated as the average over all 5 regions. A higher percentage reflects more damage to the corneal surface. Both eyes contributed to the analysis. No hypotheses were formulated; no inferences were made and only descriptive statistics were used in the reporting.
Outcome measures
| Measure |
Test 1
n=33 Participants
Contact lens with investigational coating 1 worn for approximately 2 hours during Period 1 or Period 2
|
Control 1
n=33 Participants
Balafilcon A contact lens worn contralaterally to Test 1 for approximately 2 hours during Period 1 or Period 2
|
Test 2
n=33 Participants
Contact lens with investigational coating 2 worn for approximately 2 hours during Period 1 or Period 2
|
Control 2
n=33 Participants
Balafilcon A contact lens worn contralaterally to Test 2 for approximately 2 hours during Period 1 or Period 2
|
|---|---|---|---|---|
|
Average Percent Area of Solution-related Corneal Staining
|
7.01 percentage of area
Standard Deviation 10.54
|
12.82 percentage of area
Standard Deviation 17.93
|
13.54 percentage of area
Standard Deviation 17.20
|
7.58 percentage of area
Standard Deviation 10.34
|
Adverse Events
Test 1
Test 2
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sr CDMA Project Lead, GCRA - Vision Care
Alcon, A Novartis Division
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place