Trial Outcomes & Findings for Performance of a Multifocal Contact Lens - Presbyopia Study (NCT NCT02450747)
NCT ID: NCT02450747
Last Updated: 2018-06-19
Results Overview
Hyperemia (Redness) was assessed using two different parts of the eye, the Bulbar and the Limbal. Hypemeria was measured using the Efron Scale in 0.5 step units. Grade 0= No Findings, Grade 1= Slight, Grade 2= Mild , Grade 3= Moderate and Grade 4 = severe. Hypermia was assessed in four regions of the eye (Inferior, Nasal, Temporal and Superior). The total grade of Conjunctival Hypermia across all regions and grades is reported. The total grade can range from 0 to 8. Where a higher grade implies worsening conjunctival hypermia
COMPLETED
NA
44 participants
Baseline to 4-Week Follow-up
2018-06-19
Participant Flow
Forty-four (44) subjects were enrolled in this study. Five (5) subjects did not meet the eligibility and were not dispensed a study article. Of the 39 subjects dispensed study lenses all subjects completed the study without any major protocol deviations.
Participant milestones
| Measure |
Multi-focal(Etafilcon A)
All subjects worn the Test Contact Lens, Multi-focal (etafilcon A) as daily wear modality over a period of four weeks.
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Performance of a Multifocal Contact Lens - Presbyopia Study
Baseline characteristics by cohort
| Measure |
Multi-focal(Etafilcon A)
n=39 Participants
All subjects wore the Test Contact Lens, Multi-focal (etafilcon A) as a daily wear modality over a period of four weeks.
|
|---|---|
|
Age, Continuous
|
54.5 Years
STANDARD_DEVIATION 7.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
33 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
39 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 4-Week Follow-upPopulation: The analysis population consists of all subjects that completed all study visits without a major protocol deviation. The analysis is conducted on subject eyes.
Hyperemia (Redness) was assessed using two different parts of the eye, the Bulbar and the Limbal. Hypemeria was measured using the Efron Scale in 0.5 step units. Grade 0= No Findings, Grade 1= Slight, Grade 2= Mild , Grade 3= Moderate and Grade 4 = severe. Hypermia was assessed in four regions of the eye (Inferior, Nasal, Temporal and Superior). The total grade of Conjunctival Hypermia across all regions and grades is reported. The total grade can range from 0 to 8. Where a higher grade implies worsening conjunctival hypermia
Outcome measures
| Measure |
Baseline
n=78 Subject Eyes
Measurements taken at baseline are on all subjects that had already been dispensed the study lens. Only baseline measurements from subject included in the analysis population was reported.
|
Multi-focal(Etafilcon A)
n=78 Subject Eyes
All subjects wore the study lens, Multi-focal (etafilcon A ) as daily wear modality over a period of four weeks.
|
|---|---|---|
|
The Total Grade of Conjunctival Hyperemia
Bulbar
|
4.25 units on a scale
Standard Deviation 1.261
|
3.72 units on a scale
Standard Deviation 1.232
|
|
The Total Grade of Conjunctival Hyperemia
Limbal
|
3.51 units on a scale
Standard Deviation 1.222
|
3.42 units on a scale
Standard Deviation 1.332
|
PRIMARY outcome
Timeframe: Baseline to 4-Week Follow-upPopulation: The analysis population consists of all subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.
Upper Lid Margin Staining was assessed using Fluorescein Staining and was measured on the Graded Scale is Grade 0: No Staining is present, Grade 1= 1% to 25% Stains, Grade 2= 26% to 50% Stains, Grade 3= 51% to 75% Stains, Grade 4 76% to 100% Stains. The percentage of eyes with upper lid margin staining for each Grade is reported.
Outcome measures
| Measure |
Baseline
n=78 Subject Eyes
Measurements taken at baseline are on all subjects that had already been dispensed the study lens. Only baseline measurements from subject included in the analysis population was reported.
|
Multi-focal(Etafilcon A)
n=78 Subject Eyes
All subjects wore the study lens, Multi-focal (etafilcon A ) as daily wear modality over a period of four weeks.
|
|---|---|---|
|
Upper Lid Margin Staining Score
Grade 0- No Staining
|
46.2 percentage of eyes
|
26.9 percentage of eyes
|
|
Upper Lid Margin Staining Score
Grade 1 - 1% to 25% Staining
|
28.2 percentage of eyes
|
44.9 percentage of eyes
|
|
Upper Lid Margin Staining Score
Grade 2 - 26% to 50% Staining
|
23.1 percentage of eyes
|
24.4 percentage of eyes
|
|
Upper Lid Margin Staining Score
Grade 3 - 51% to 75% Staining
|
2.6 percentage of eyes
|
3.9 percentage of eyes
|
|
Upper Lid Margin Staining Score
Grade 4 - 76% to 100% Staining
|
0 percentage of eyes
|
0.0 percentage of eyes
|
PRIMARY outcome
Timeframe: Baseline to 4- Week Follow-upPopulation: The analysis population consists of all subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.
Corneal staining Area Grade was assessed in throughout five (5) regions in the eye (Central, Nasal, Temporal, Inferior, Superior). Corneal Staining was Graded using the Efron scale from 0 to 4 in 0.1 unit steps and converted to a percentage of region that was stained. The average percent of region that was stained was calculated and reported.
Outcome measures
| Measure |
Baseline
n=78 Subject Eyes
Measurements taken at baseline are on all subjects that had already been dispensed the study lens. Only baseline measurements from subject included in the analysis population was reported.
|
Multi-focal(Etafilcon A)
n=78 Subject Eyes
All subjects wore the study lens, Multi-focal (etafilcon A ) as daily wear modality over a period of four weeks.
|
|---|---|---|
|
Average Corneal Staining Area Grade
Central
|
0.04 Average Percentage of Staining
Standard Deviation 0.025
|
0.05 Average Percentage of Staining
Standard Deviation 0.297
|
|
Average Corneal Staining Area Grade
Nasal
|
0.08 Average Percentage of Staining
Standard Deviation 0.254
|
0.06 Average Percentage of Staining
Standard Deviation 0.224
|
|
Average Corneal Staining Area Grade
Inferior
|
0.039 Average Percentage of Staining
Standard Deviation 0.590
|
0.28 Average Percentage of Staining
Standard Deviation 0.472
|
|
Average Corneal Staining Area Grade
Temporal
|
0.09 Average Percentage of Staining
Standard Deviation 0.287
|
0.03 Average Percentage of Staining
Standard Deviation 0.203
|
|
Average Corneal Staining Area Grade
Superior
|
0.08 Average Percentage of Staining
Standard Deviation 0.320
|
0.06 Average Percentage of Staining
Standard Deviation 0.228
|
Adverse Events
Multi-focal(Etafilcon A)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Tom Karkkainen O.D., M.S., F.A.A.O- Sr. Research Principal Optometrist
Johnson & Johnson Vision Care Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60