Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 1
Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT04527978
Collaborator
(none)
56
4
2
1.7
14
8.2
Study Details
Study Description
Brief Summary
The primary objective of this study is to evaluate the overall performance of PRECISION1 contact lenses when compared to Biotrue ONEday contact lenses.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Subjects are expected to attend 3 study visits and wear the PRECISION1 and Biotrue ONEday study lenses in a crossover design for approximately 8 days of exposure to each study lens type. The expected duration of subject participation is up to 22 days.
Study Design
Study Type:
Interventional
Actual Enrollment
:
56 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 1
Actual Study Start Date
:
Sep 15, 2020
Actual Primary Completion Date
:
Nov 6, 2020
Actual Study Completion Date
:
Nov 6, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: PRECISION1, then Biotrue ONEday Verofilcon A contact lenses worn first, with nesofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality. |
Device: Verofilcon A contact lenses
Spherical soft contact lenses for daily disposable wear
Other Names:
Device: Nesofilcon A contact lenses
Spherical soft contact lenses for daily disposable wear
Other Names:
|
| Other: Biotrue ONEday, then PRECISION1 Nesofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality. |
Device: Verofilcon A contact lenses
Spherical soft contact lenses for daily disposable wear
Other Names:
Device: Nesofilcon A contact lenses
Spherical soft contact lenses for daily disposable wear
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Distance Visual Acuity (VA) With Study Lenses [Day 8 (-0/+3 days) after 10 (-2/+6) hours of wear, each study lens type]
Distance VA was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:
-
Subject must be able to understand and must sign an Institution Review Board (IRB) approved Informed Consent Form.
-
Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
-
Willing to wear contact lenses for at least 16 hours per day on one of the days with each lens type.
-
Other protocol-specified inclusion criteria may apply.
Key Exclusion Criteria:
-
Any ocular condition that contraindicates contact lens wear.
-
Previous or current habitual wearer of PRECISION1, Biotrue ONEday, or DAILIES TOTAL1 contact lenses.
-
Other protocol-specified exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alcon Investigator 6565 | Maitland | Florida | United States | 32751 |
| 2 | Alcon Investigator 6402 | Medina | Minnesota | United States | 55340 |
| 3 | Alcon Investigator 6313 | Powell | Ohio | United States | 43065 |
| 4 | Alcon Investigator 8028 | Wichita Falls | Texas | United States | 76308 |
Sponsors and Collaborators
- Alcon Research
Investigators
- Study Director: CDMA Project Lead, Vision Care, Alcon Research, LLC
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT04527978
Other Study ID Numbers:
- CLE383-P003
First Posted:
Aug 27, 2020
Last Update Posted:
Nov 23, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Alcon Research
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Subjects were recruited from 4 investigative sites located in the United States. |
|---|---|
| Pre-assignment Detail | Of the 56 subjects enrolled in the study, 1 subject was discontinued after randomization and prior to exposure to the study lenses. This reporting group includes all randomized and exposed subjects (55). |
| Arm/Group Title | PRECISION1, Then Biotrue ONEday | Biotrue ONEday, Then PRECISION1 |
|---|---|---|
| Arm/Group Description | Verofilcon A contact lenses worn first, with nesofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality. | Nesofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality. |
| Period Title: First Wear Period (8 -0/+3 Days) | ||
| STARTED | 27 | 28 |
| COMPLETED | 26 | 28 |
| NOT COMPLETED | 1 | 0 |
| Period Title: First Wear Period (8 -0/+3 Days) | ||
| STARTED | 26 | 28 |
| COMPLETED | 26 | 28 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | PRECISION1, Then Biotrue ONEday | Biotrue ONEday, Then PRECISION1 | Total |
|---|---|---|---|
| Arm/Group Description | Verofilcon A contact lenses worn first, with nesofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality. | Nesofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality. | Total of all reporting groups |
| Overall Participants | 27 | 28 | 55 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
33.7
(6.3)
|
34.3
(8.9)
|
34.0
(7.7)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
20
74.1%
|
25
89.3%
|
45
81.8%
|
| Male |
7
25.9%
|
3
10.7%
|
10
18.2%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
3
11.1%
|
1
3.6%
|
4
7.3%
|
| Not Hispanic or Latino |
24
88.9%
|
27
96.4%
|
51
92.7%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
1
3.6%
|
1
1.8%
|
| Black or African American |
1
3.7%
|
1
3.6%
|
2
3.6%
|
| White |
25
92.6%
|
26
92.9%
|
51
92.7%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
1
3.7%
|
0
0%
|
1
1.8%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
27
100%
|
28
100%
|
55
100%
|
Outcome Measures
| Title | Distance Visual Acuity (VA) With Study Lenses |
|---|---|
| Description | Distance VA was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed. |
| Time Frame | Day 8 (-0/+3 days) after 10 (-2/+6) hours of wear, each study lens type |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Analysis Set with non-missing response |
| Arm/Group Title | PRECISION1 | Biotrue ONEday |
|---|---|---|
| Arm/Group Description | Verofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -0/+3 days in a daily disposable modality | Nesofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -0/+3 days in a daily disposable modality |
| Measure Participants | 54 | 54 |
| Measure eyes | 108 | 108 |
| Mean (Standard Deviation) [logMAR] |
-0.13
(0.08)
|
-0.12
(0.08)
|
Adverse Events
| Time Frame | Adverse events (AE's) were collected from time of consent to study exit, up to 22 days. | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study. | |||||||||
| Arm/Group Title | Pretreatment | PRECISION1 Ocular | PRECISION1 Nonocular | Biotrue ONEday Ocular | Biotrue ONEday Nonocular | |||||
| Arm/Group Description | Events reported in this group occurred prior to exposure to the study contact lenses | Events reported in this group occurred while exposed to the verofilcon A contact lenses | Events reported in this group occurred while exposed to the verofilcon A contact lenses | Events reported in this group occurred while exposed to the nesofilcon A contact lenses | Events reported in this group occurred while exposed to the nesofilcon A contact lenses | |||||
All Cause Mortality |
||||||||||
| Pretreatment | PRECISION1 Ocular | PRECISION1 Nonocular | Biotrue ONEday Ocular | Biotrue ONEday Nonocular | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/55 (0%) | 0/110 (0%) | 0/55 (0%) | 0/108 (0%) | 0/54 (0%) | |||||
Serious Adverse Events |
||||||||||
| Pretreatment | PRECISION1 Ocular | PRECISION1 Nonocular | Biotrue ONEday Ocular | Biotrue ONEday Nonocular | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/55 (0%) | 0/110 (0%) | 0/55 (0%) | 0/108 (0%) | 0/54 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| Pretreatment | PRECISION1 Ocular | PRECISION1 Nonocular | Biotrue ONEday Ocular | Biotrue ONEday Nonocular | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/55 (0%) | 0/110 (0%) | 0/55 (0%) | 0/108 (0%) | 0/54 (0%) | |||||
Limitations/Caveats
[Not Specified]
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 | CDMA Project Lead, Vision Care |
|---|---|
| Organization | Alcon Research, LLC |
| Phone | 1-888-451-3937 |
| alcon.medinfo@alcon.com |
Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT04527978
Other Study ID Numbers:
- CLE383-P003
First Posted:
Aug 27, 2020
Last Update Posted:
Nov 23, 2021
Last Verified:
Oct 1, 2021