Clinical Evaluation of the Safety and Efficacy of a New Multifocal Contact Lens
Study Details
Study Description
Brief Summary
The purpose of this study was to demonstrate substantial equivalence of the new DAILIES® AquaComfort Plus® Multifocal (DACP MF) contact lens to the commercially available Focus® DAILIES® Progressives (FDP) contact lens.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: DAILIES® AquaComfort Plus® Multifocal Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis |
Device: Nelfilcon A multifocal contact lens with comfort additive
|
| Active Comparator: Focus® DAILIES® Progressives Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis |
Device: Nelfilcon A multifocal contact lens
|
Outcome Measures
Primary Outcome Measures
- Subjective Overall Vision [Up to Day 30]
The participant was instructed to, "Please rate the aggregate of distance, intermediate, and near vision quality. Fill in the circle below the number that indicates your selection. Rate eyes together, marking only 1 circle for both eyes. Higher numbers mean better vision." The response was recorded on a continuous scale from 1-10 (1=poor, 10=excellent).
Secondary Outcome Measures
- Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses [Up to Day 30]
Visual Acuity was tested while reading a chart at 20-foot equivalent distance from the participant with both eyes together. The Snellen fraction compares the participant's result to the result expected from the 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity.
- Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses [Up to Day 30]
Visual Acuity was tested while reading charts at a distance of 40 cm from the participant with both eyes together. The Snellen fraction 20/20 represents 'normal' near vision. A larger denominator indicates a lower visual acuity.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Sign Informed Consent Document.
-
Presbyopic and require a spectacle add of up to and including 3.00 diopters (D).
-
Currently wear soft contact lenses.
-
Willing and able to wear multifocal contact lenses in both eyes within the available range of powers for this trial and comply with the wearing and replacement schedule.
-
Manifest cylinder less than or equal to 1.00 D.
-
Able to achieve best corrected visual acuity (BCVA) of 20/25 or better (Snellen) in each eye at distance (as determined by manifest refraction).
-
Able to achieve distance visual acuity of 20/40 (Snellen) or better in each eye with study lenses and deem subjective vision as satisfactory at time of dispense.
-
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
-
Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment.
-
Any use of systemic or ocular medications for which contact lens wear could be contraindicated.
-
History of corneal or refractive surgery.
-
Biomicroscopy findings greater than Grade 2 at baseline.
-
A pathologically dry eye that precludes contact lens wear.
-
Monocular (only one eye with functional vision).
-
Wear habitual contact lenses on an extended wear schedule (any number of nights of overnight wear on a regular basis).
-
History of intolerance or hypersensitivity to any component of the investigational products.
-
Concurrent participation in a contact lens or contact lens care product clinical trial or within the previous 30 days.
-
Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment.
-
Other protocol-defined exclusion criteria may apply.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Alcon Research
Investigators
- Study Director: Justin Webb, O.D., Alcon Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- C-12-054
Study Results
Participant Flow
| Recruitment Details | Participants were recruited from 9 study centers located in the United States. |
|---|---|
| Pre-assignment Detail | Of the 83 consented participants, 2 were exited as screen failures prior to randomization, and 2 were exited after randomization but prior to product dispense. This reporting group includes all randomized participants who were dispensed study product (79). |
| Arm/Group Title | DAILIES® AquaComfort Plus® Multifocal | Focus® DAILIES® Progressives |
|---|---|---|
| Arm/Group Description | Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis | Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis |
| Period Title: Overall Study | ||
| STARTED | 52 | 27 |
| COMPLETED | 50 | 26 |
| NOT COMPLETED | 2 | 1 |
Baseline Characteristics
| Arm/Group Title | DAILIES® AquaComfort Plus® Multifocal | Focus® DAILIES® Progressives | Total |
|---|---|---|---|
| Arm/Group Description | Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis | Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis | Total of all reporting groups |
| Overall Participants | 52 | 27 | 79 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
49.9
(5.19)
|
49.7
(5.21)
|
49.8
(5.16)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
34
65.4%
|
22
81.5%
|
56
70.9%
|
| Male |
18
34.6%
|
5
18.5%
|
23
29.1%
|
Outcome Measures
| Title | Subjective Overall Vision |
|---|---|
| Description | The participant was instructed to, "Please rate the aggregate of distance, intermediate, and near vision quality. Fill in the circle below the number that indicates your selection. Rate eyes together, marking only 1 circle for both eyes. Higher numbers mean better vision." The response was recorded on a continuous scale from 1-10 (1=poor, 10=excellent). |
| Time Frame | Up to Day 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all randomized and dispensed participants who completed the study. No imputation was used for missing values. Here, "n" is the number of participants with non-missing values at the specific time point for each arm. group, |
| Arm/Group Title | DAILIES® AquaComfort Plus® Multifocal | Focus® DAILIES® Progressives |
|---|---|---|
| Arm/Group Description | Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis | Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis |
| Measure Participants | 50 | 26 |
| Dispense (Day 0) (n=49,26) |
8.7
(1.1)
|
8.4
(1.2)
|
| Day 3 (n=49,26) |
8.4
(1.3)
|
7.5
(1.7)
|
| Day 14 (n=50,26) |
8.6
(1.2)
|
7.7
(1.9)
|
| Day 30 (n=50,26) |
8.5
(1.1)
|
7.6
(1.9)
|
| Title | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses |
|---|---|
| Description | Visual Acuity was tested while reading a chart at 20-foot equivalent distance from the participant with both eyes together. The Snellen fraction compares the participant's result to the result expected from the 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. |
| Time Frame | Up to Day 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all randomized and dispensed participants who completed the study. |
| Arm/Group Title | DACP MF @ Dispense | DACP MF @ Day 3 | DACP MF @ Day 14 | DACP MF @ Day 30 | FDP @ Dispense | FDP @ Day 3 | FDP @ Day 14 | FDP @ Day 30 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis | Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis | Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis | Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis | Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis | Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis | Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis | Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis |
| Measure Participants | 50 | 50 | 50 | 50 | 26 | 26 | 26 | 26 |
| 20/15 |
5
9.6%
|
4
14.8%
|
4
5.1%
|
2
NaN
|
0
NaN
|
0
NaN
|
1
NaN
|
2
NaN
|
| 20/20 |
40
76.9%
|
38
140.7%
|
40
50.6%
|
42
NaN
|
22
NaN
|
24
NaN
|
21
NaN
|
19
NaN
|
| 20/25 |
5
9.6%
|
8
29.6%
|
6
7.6%
|
6
NaN
|
4
NaN
|
1
NaN
|
4
NaN
|
5
NaN
|
| 20/30 |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
1
NaN
|
0
NaN
|
0
NaN
|
| Title | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses |
|---|---|
| Description | Visual Acuity was tested while reading charts at a distance of 40 cm from the participant with both eyes together. The Snellen fraction 20/20 represents 'normal' near vision. A larger denominator indicates a lower visual acuity. |
| Time Frame | Up to Day 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| This reporting group includes all randomized and dispensed participants who completed the study. |
| Arm/Group Title | DACP MF @ Dispense | DACP MF @ Day 3 | DACP MF @ Day 14 | DACP MF @ Day 30 | FDP @ Dispense | FDP @ Day 3 | FDP @ Day 14 | FDP @ Day 30 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis | Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis | Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis | Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis | Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis | Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis | Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis | Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis |
| Measure Participants | 50 | 50 | 50 | 50 | 26 | 26 | 26 | 26 |
| 20/10 |
0
0%
|
1
3.7%
|
1
1.3%
|
0
NaN
|
1
NaN
|
1
NaN
|
1
NaN
|
0
NaN
|
| 20/12.5 |
1
1.9%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
1
NaN
|
2
NaN
|
0
NaN
|
| 20/16 |
2
3.8%
|
0
0%
|
2
2.5%
|
0
NaN
|
0
NaN
|
0
NaN
|
2
NaN
|
0
NaN
|
| 20/20 |
19
36.5%
|
18
66.7%
|
15
19%
|
23
NaN
|
3
NaN
|
5
NaN
|
5
NaN
|
8
NaN
|
| 20/25 |
21
40.4%
|
24
88.9%
|
25
31.6%
|
20
NaN
|
14
NaN
|
10
NaN
|
10
NaN
|
14
NaN
|
| 20/30 |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
1
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| 20/32 |
6
11.5%
|
6
22.2%
|
6
7.6%
|
7
NaN
|
7
NaN
|
8
NaN
|
5
NaN
|
4
NaN
|
| 20/40 |
0
0%
|
1
3.7%
|
1
1.3%
|
0
NaN
|
0
NaN
|
0
NaN
|
1
NaN
|
0
NaN
|
| 20/50 |
1
1.9%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
1
NaN
|
0
NaN
|
0
NaN
|
Adverse Events
| Time Frame | An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign in subjects, users, or other persons, whether or not related to the medical device. AEs were collected for the duration of the study (2 months). | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | AEs were obtained as solicited comments and as observations by the study Investigator as outlined in the study protocol. This analysis population includes all randomized participants who were dispensed study product (79). | |||
| Arm/Group Title | DAILIES® AquaComfort Plus® Multifocal | Focus® DAILIES® Progressives | ||
| Arm/Group Description | Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis | Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis | ||
All Cause Mortality |
||||
| DAILIES® AquaComfort Plus® Multifocal | Focus® DAILIES® Progressives | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| DAILIES® AquaComfort Plus® Multifocal | Focus® DAILIES® Progressives | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/52 (0%) | 0/27 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| DAILIES® AquaComfort Plus® Multifocal | Focus® DAILIES® Progressives | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/52 (0%) | 0/27 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
| Name/Title | Stacie Cummings, O.D. |
|---|---|
| Organization | Alcon Research, Ltd. |
| Phone | 1-888-451-3937 |
| alcon.medinfo@alcon.com |
- C-12-054