Trial Outcomes & Findings for Prospective Study of an Investigational Toric Soft Contact Lens (NCT NCT01461811)
NCT ID: NCT01461811
Last Updated: 2013-10-17
Results Overview
Visual acuity, as assessed for each eye individually. Participant read a distance Snellen chart while wearing study lenses. The percentage of eyes with VA recorded as 20/30 or better is reported. Both eyes contributed to the percentage.
COMPLETED
NA
154 participants
Up to Month 3
2013-10-17
Participant Flow
Participants were recruited from ten US study centers.
Of the 154 participants enrolled, ten participants were considered enrolled, but not dispensed, due to not meeting inclusion criteria or withdrawal of consent. This reporting group includes all enrolled and dispensed participants (144).
Participant milestones
| Measure |
DAILIES® AquaComfort Plus® Toric
Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
|
Focus® DAILIES® Toric
Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
|
|---|---|---|
|
Overall Study
STARTED
|
95
|
49
|
|
Overall Study
COMPLETED
|
91
|
46
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
DAILIES® AquaComfort Plus® Toric
Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
|
Focus® DAILIES® Toric
Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Subject decision unrelated to an AE
|
1
|
1
|
|
Overall Study
Noncompliance
|
1
|
1
|
Baseline Characteristics
Prospective Study of an Investigational Toric Soft Contact Lens
Baseline characteristics by cohort
| Measure |
DAILIES® AquaComfort Plus® Toric
n=95 Participants
Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
|
Focus® DAILIES® Toric
n=49 Participants
Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
33.6 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
37.2 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
34.9 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Month 3Population: All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.
Visual acuity, as assessed for each eye individually. Participant read a distance Snellen chart while wearing study lenses. The percentage of eyes with VA recorded as 20/30 or better is reported. Both eyes contributed to the percentage.
Outcome measures
| Measure |
DAILIES® AquaComfort Plus® Toric
n=91 Participants
Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
|
Focus® DAILIES® Toric
n=46 Participants
Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
|
|---|---|---|
|
Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)
Dispense
|
98.9 Percentage of eyes
|
98.9 Percentage of eyes
|
|
Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)
Week 1
|
98.9 Percentage of eyes
|
97.8 Percentage of eyes
|
|
Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)
Week 2
|
98.9 Percentage of eyes
|
97.8 Percentage of eyes
|
|
Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)
Month 1
|
98.9 Percentage of eyes
|
97.8 Percentage of eyes
|
|
Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)
Month 2
|
98.9 Percentage of eyes
|
98.9 Percentage of eyes
|
|
Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)
Month 3
|
98.9 Percentage of eyes
|
96.7 Percentage of eyes
|
SECONDARY outcome
Timeframe: Up to Month 3Population: All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.
Insertion comfort (30 seconds to 1 minute), as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.
Outcome measures
| Measure |
DAILIES® AquaComfort Plus® Toric
n=91 Participants
Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
|
Focus® DAILIES® Toric
n=46 Participants
Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
|
|---|---|---|
|
Subjective Rating of Insertion Comfort
Dispense
|
8.9 Units on a scale
Standard Deviation 1.3
|
9.0 Units on a scale
Standard Deviation 1.4
|
|
Subjective Rating of Insertion Comfort
Week 1
|
9.0 Units on a scale
Standard Deviation 1.3
|
9.0 Units on a scale
Standard Deviation 1.4
|
|
Subjective Rating of Insertion Comfort
Week 2
|
9.0 Units on a scale
Standard Deviation 1.1
|
9.1 Units on a scale
Standard Deviation 1.2
|
|
Subjective Rating of Insertion Comfort
Month 1
|
9.0 Units on a scale
Standard Deviation 1.1
|
9.1 Units on a scale
Standard Deviation 1.1
|
|
Subjective Rating of Insertion Comfort
Month 2
|
9.1 Units on a scale
Standard Deviation 0.9
|
9.3 Units on a scale
Standard Deviation 0.9
|
|
Subjective Rating of Insertion Comfort
Month 3
|
9.2 Units on a scale
Standard Deviation 1.0
|
9.1 Units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Up to Month 3Population: All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.
End of day comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.
Outcome measures
| Measure |
DAILIES® AquaComfort Plus® Toric
n=91 Participants
Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
|
Focus® DAILIES® Toric
n=46 Participants
Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
|
|---|---|---|
|
Subjective Rating of End of Day Comfort
Week 1
|
7.2 Units on a scale
Standard Deviation 2.5
|
7.6 Units on a scale
Standard Deviation 2.1
|
|
Subjective Rating of End of Day Comfort
Week 2
|
7.6 Units on a scale
Standard Deviation 2.1
|
7.9 Units on a scale
Standard Deviation 1.8
|
|
Subjective Rating of End of Day Comfort
Month 1
|
7.6 Units on a scale
Standard Deviation 2.0
|
8.2 Units on a scale
Standard Deviation 1.4
|
|
Subjective Rating of End of Day Comfort
Month 2
|
7.6 Units on a scale
Standard Deviation 2.1
|
7.9 Units on a scale
Standard Deviation 1.9
|
|
Subjective Rating of End of Day Comfort
Month 3
|
7.7 Units on a scale
Standard Deviation 1.9
|
7.8 Units on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Up to Month 3Population: All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.
Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.
Outcome measures
| Measure |
DAILIES® AquaComfort Plus® Toric
n=91 Participants
Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
|
Focus® DAILIES® Toric
n=46 Participants
Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
|
|---|---|---|
|
Subjective Rating of Overall Comfort
Week 1
|
8.1 Units on a scale
Standard Deviation 1.7
|
8.7 Units on a scale
Standard Deviation 1.1
|
|
Subjective Rating of Overall Comfort
Week 2
|
8.3 Units on a scale
Standard Deviation 1.5
|
8.7 Units on a scale
Standard Deviation 1.3
|
|
Subjective Rating of Overall Comfort
Month 1
|
8.4 Units on a scale
Standard Deviation 1.4
|
8.8 Units on a scale
Standard Deviation 1.1
|
|
Subjective Rating of Overall Comfort
Month 2
|
8.2 Units on a scale
Standard Deviation 1.5
|
8.7 Units on a scale
Standard Deviation 1.2
|
|
Subjective Rating of Overall Comfort
Month 3
|
8.4 Units on a scale
Standard Deviation 1.4
|
8.7 Units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Up to Month 3Population: All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.
End of day dryness, as rated by the participant on a 10-point scale, with 1 being dry and 10 being not dry. The participant rated both eyes together by providing one single rating.
Outcome measures
| Measure |
DAILIES® AquaComfort Plus® Toric
n=91 Participants
Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
|
Focus® DAILIES® Toric
n=46 Participants
Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
|
|---|---|---|
|
Subjective Rating of End of Day Dryness
Week 1
|
7.1 Units on a scale
Standard Deviation 2.7
|
7.1 Units on a scale
Standard Deviation 2.3
|
|
Subjective Rating of End of Day Dryness
Week 2
|
7.2 Units on a scale
Standard Deviation 2.3
|
7.6 Units on a scale
Standard Deviation 2.1
|
|
Subjective Rating of End of Day Dryness
Month 1
|
7.3 Units on a scale
Standard Deviation 2.0
|
7.9 Units on a scale
Standard Deviation 1.6
|
|
Subjective Rating of End of Day Dryness
Month 2
|
7.4 Units on a scale
Standard Deviation 2.1
|
7.6 Units on a scale
Standard Deviation 2.0
|
|
Subjective Rating of End of Day Dryness
Month 3
|
7.5 Units on a scale
Standard Deviation 2.0
|
7.4 Units on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Up to Month 3Population: All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.
Overall vision, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.
Outcome measures
| Measure |
DAILIES® AquaComfort Plus® Toric
n=91 Participants
Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
|
Focus® DAILIES® Toric
n=46 Participants
Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
|
|---|---|---|
|
Subjective Rating of Overall Vision
Dispense
|
8.6 Units on a scale
Standard Deviation 1.4
|
8.9 Units on a scale
Standard Deviation 1.2
|
|
Subjective Rating of Overall Vision
Week 1
|
8.7 Units on a scale
Standard Deviation 1.6
|
8.8 Units on a scale
Standard Deviation 1.1
|
|
Subjective Rating of Overall Vision
Week 2
|
8.8 Units on a scale
Standard Deviation 1.4
|
8.9 Units on a scale
Standard Deviation 1.0
|
|
Subjective Rating of Overall Vision
Month 1
|
8.7 Units on a scale
Standard Deviation 1.3
|
8.9 Units on a scale
Standard Deviation 0.9
|
|
Subjective Rating of Overall Vision
Month 2
|
8.7 Units on a scale
Standard Deviation 1.4
|
8.9 Units on a scale
Standard Deviation 0.9
|
|
Subjective Rating of Overall Vision
Month 3
|
8.9 Units on a scale
Standard Deviation 1.2
|
8.8 Units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Up to Month 3Population: All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.
Overall handling, as rated by the participant on a 10-point scale, with 1 being difficult and 10 being easy. The participant rated both eyes together by providing one single rating.
Outcome measures
| Measure |
DAILIES® AquaComfort Plus® Toric
n=91 Participants
Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
|
Focus® DAILIES® Toric
n=46 Participants
Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
|
|---|---|---|
|
Subjective Rating of Overall Handling
Dispense
|
9.0 Units on a scale
Standard Deviation 1.2
|
9.0 Units on a scale
Standard Deviation 1.7
|
|
Subjective Rating of Overall Handling
Week 1
|
8.8 Units on a scale
Standard Deviation 1.4
|
8.7 Units on a scale
Standard Deviation 1.2
|
|
Subjective Rating of Overall Handling
Week 2
|
9.0 Units on a scale
Standard Deviation 0.9
|
8.8 Units on a scale
Standard Deviation 1.2
|
|
Subjective Rating of Overall Handling
Month 1
|
9.0 Units on a scale
Standard Deviation 1.2
|
8.9 Units on a scale
Standard Deviation 1.1
|
|
Subjective Rating of Overall Handling
Month 2
|
9.0 Units on a scale
Standard Deviation 1.2
|
9.0 Units on a scale
Standard Deviation 1.1
|
|
Subjective Rating of Overall Handling
Month 3
|
9.0 Units on a scale
Standard Deviation 1.1
|
9.1 Units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Up to Month 3Population: All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.
Lens centration, as assessed by the investigator for each eye individually. Lens centration was graded on a 5-point scale: 0=centered, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as "centered" or "slight decentration" is reported. Lenses from both eyes contributed to the percentage.
Outcome measures
| Measure |
DAILIES® AquaComfort Plus® Toric
n=91 Participants
Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
|
Focus® DAILIES® Toric
n=46 Participants
Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
|
|---|---|---|
|
Lens Centration (Centered, Slight Decentration)
Dispense
|
97.8 Percentage of lenses
|
98.9 Percentage of lenses
|
|
Lens Centration (Centered, Slight Decentration)
Week 1
|
100 Percentage of lenses
|
100 Percentage of lenses
|
|
Lens Centration (Centered, Slight Decentration)
Week 2
|
100 Percentage of lenses
|
100 Percentage of lenses
|
|
Lens Centration (Centered, Slight Decentration)
Month 1
|
100 Percentage of lenses
|
100 Percentage of lenses
|
|
Lens Centration (Centered, Slight Decentration)
Month 2
|
100 Percentage of lenses
|
100 Percentage of lenses
|
|
Lens Centration (Centered, Slight Decentration)
Month 3
|
99.4 Percentage of lenses
|
100 Percentage of lenses
|
SECONDARY outcome
Timeframe: Up to Month 3Population: All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.
Lens fit, as assessed by the investigator for each eye individually. Lens fit was graded on a 5-point scale: 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight. The combined percentage of lenses assessed as "optimal," "acceptably loose," or "acceptably tight" is reported. Lenses from both eyes contributed to the percentage.
Outcome measures
| Measure |
DAILIES® AquaComfort Plus® Toric
n=91 Participants
Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
|
Focus® DAILIES® Toric
n=46 Participants
Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
|
|---|---|---|
|
Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)
Dispense
|
100 Percentage of lenses
|
100 Percentage of lenses
|
|
Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)
Week 1
|
100 Percentage of lenses
|
100 Percentage of lenses
|
|
Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)
Week 2
|
100 Percentage of lenses
|
100 Percentage of lenses
|
|
Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)
Month 1
|
100 Percentage of lenses
|
100 Percentage of lenses
|
|
Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)
Month 2
|
100 Percentage of lenses
|
100 Percentage of lenses
|
|
Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)
Month 3
|
100 Percentage of lenses
|
100 Percentage of lenses
|
SECONDARY outcome
Timeframe: Up to Month 3Population: All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.
Front surface wettability (i.e., assessment of the disruption of the front surface wettability of the contact lens), as assessed by the investigator for each eye individually. Front surface wettability was graded on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage.
Outcome measures
| Measure |
DAILIES® AquaComfort Plus® Toric
n=91 Participants
Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
|
Focus® DAILIES® Toric
n=46 Participants
Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
|
|---|---|---|
|
Front Surface Wettability (None, Very Slight)
Dispense
|
99.4 Percentage of lenses
|
100 Percentage of lenses
|
|
Front Surface Wettability (None, Very Slight)
Week 1
|
92.2 Percentage of lenses
|
97.8 Percentage of lenses
|
|
Front Surface Wettability (None, Very Slight)
Week 2
|
94.9 Percentage of lenses
|
95.6 Percentage of lenses
|
|
Front Surface Wettability (None, Very Slight)
Month 1
|
97.2 Percentage of lenses
|
93.5 Percentage of lenses
|
|
Front Surface Wettability (None, Very Slight)
Month 2
|
91.1 Percentage of lenses
|
86.7 Percentage of lenses
|
|
Front Surface Wettability (None, Very Slight)
Month 3
|
91.6 Percentage of lenses
|
88.0 Percentage of lenses
|
SECONDARY outcome
Timeframe: Up to Month 3Population: All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.
Front surface deposits on the contact lens, as assessed by the investigator for each eye individually. Front surface deposits were graded on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage.
Outcome measures
| Measure |
DAILIES® AquaComfort Plus® Toric
n=91 Participants
Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
|
Focus® DAILIES® Toric
n=46 Participants
Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
|
|---|---|---|
|
Front Surface Deposits (None, Very Slight)
Dispense
|
100 Percentage of lenses
|
100 Percentage of lenses
|
|
Front Surface Deposits (None, Very Slight)
Week 1
|
96.1 Percentage of lenses
|
100 Percentage of lenses
|
|
Front Surface Deposits (None, Very Slight)
Week 2
|
98.3 Percentage of lenses
|
100 Percentage of lenses
|
|
Front Surface Deposits (None, Very Slight)
Month 1
|
98.9 Percentage of lenses
|
99 Percentage of lenses
|
|
Front Surface Deposits (None, Very Slight)
Month 2
|
98.9 Percentage of lenses
|
96.7 Percentage of lenses
|
|
Front Surface Deposits (None, Very Slight)
Month 3
|
96.1 Percentage of lenses
|
97.8 Percentage of lenses
|
SECONDARY outcome
Timeframe: Up to Month 3Population: All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.
Back surface debris/deposits on the contact lens, as assessed by the investigator for each eye individually. Back surface debris/deposits were graded on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage.
Outcome measures
| Measure |
DAILIES® AquaComfort Plus® Toric
n=91 Participants
Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
|
Focus® DAILIES® Toric
n=46 Participants
Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
|
|---|---|---|
|
Back Surface Debris/Deposits (None, Very Slight)
Dispense
|
100 Percentage of lenses
|
100 Percentage of lenses
|
|
Back Surface Debris/Deposits (None, Very Slight)
Week 1
|
98.9 Percentage of lenses
|
100 Percentage of lenses
|
|
Back Surface Debris/Deposits (None, Very Slight)
Week 2
|
100 Percentage of lenses
|
100 Percentage of lenses
|
|
Back Surface Debris/Deposits (None, Very Slight)
Month 1
|
100 Percentage of lenses
|
100 Percentage of lenses
|
|
Back Surface Debris/Deposits (None, Very Slight)
Month 2
|
96.6 Percentage of lenses
|
96.7 Percentage of lenses
|
|
Back Surface Debris/Deposits (None, Very Slight)
Month 3
|
99.4 Percentage of lenses
|
98.9 Percentage of lenses
|
Adverse Events
DAILIES® AquaComfort Plus® Toric
Focus® DAILIES® Toric
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 For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.
- Publication restrictions are in place
Restriction type: OTHER