Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel Lens
Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT04178720
Collaborator
(none)
119
8
2
4.4
14.9
3.4
Study Details
Study Description
Brief Summary
The purpose of this clinical study is to evaluate the safety and effectiveness of an investigational soft contact lens compared to a commercially available soft contact lens when worn for daily wear and replaced monthly.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Subjects are expected to attend 6 study visits. The expected duration of study lens exposure is approximately 3 months.
Study Design
Study Type:
Interventional
Actual Enrollment
:
119 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel Lens
Actual Study Start Date
:
Jan 28, 2020
Actual Primary Completion Date
:
Jun 10, 2020
Actual Study Completion Date
:
Jun 10, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LID018869 Lehfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only. The lenses will be removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period. |
Device: Lehfilcon A contact lenses
Investigational silicone hydrogel contact lenses
Other Names:
Device: CLEAR CARE
Hydrogen peroxide-based system for cleaning and disinfecting silicone hydrogel contact lenses
Other Names:
|
| Active Comparator: Biofinity Comfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only. The lenses will be removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period. |
Device: Comfilcon A contact lenses
Commercially available silicone hydrogel contact lenses
Other Names:
Device: CLEAR CARE
Hydrogen peroxide-based system for cleaning and disinfecting silicone hydrogel contact lenses
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Distance VA (logMAR) With Study Lenses - Completed Eyes [Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up, Month 2 follow-up, Month 3 follow-up (at least 4 hours after lens insertion at each follow-up assessment visit)]
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.
- Distance VA (logMAR) With Study Lenses - Discontinued Eyes [Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up]
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:
-
Successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
-
Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.
-
Other protocol-specified inclusion criteria may apply.
Key Exclusion Criteria:
-
Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
-
Habitually wearing Biofinity contact lenses.
-
Monovision contact lens wearers.
-
Other protocol-specified exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alcon Investigative Site | Longwood | Florida | United States | 32779 |
| 2 | Alcon Investigative Site | Maitland | Florida | United States | 32751 |
| 3 | Alcon Investigative Site | Orlando | Florida | United States | 32803 |
| 4 | Alcon Investigative Site | Bloomington | Illinois | United States | 61704 |
| 5 | Alcon Investigative Site | Medina | Minnesota | United States | 55340 |
| 6 | Alcon Investigative Site | Granville | Ohio | United States | 43023 |
| 7 | Alcon Investigative Site | Memphis | Tennessee | United States | 38111 |
| 8 | Alcon Investigative Site | Memphis | Tennessee | United States | 38119 |
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:
NCT04178720
Other Study ID Numbers:
- CLY935-C010
First Posted:
Nov 26, 2019
Last Update Posted:
Oct 19, 2021
Last Verified:
Sep 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
Keywords provided by Alcon Research
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Subjects were enrolled at 8 investigative sites located in the US. |
|---|---|
| Pre-assignment Detail | Of the 119 enrolled, 1 subject was screen failed. This reporting group includes all enrolled and dispensed subjects/eyes (118/236). |
| Arm/Group Title | Biofinity | LID018869 |
|---|---|---|
| Arm/Group Description | Comfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only, as randomized. Lenses were removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period. | Lehfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only, as randomized. Lenses were removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period. |
| Period Title: Overall Study | ||
| STARTED | 40 | 78 |
| COMPLETED | 38 | 77 |
| NOT COMPLETED | 2 | 1 |
Baseline Characteristics
| Arm/Group Title | Biofinity | LID018869 | Total |
|---|---|---|---|
| Arm/Group Description | Comfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only, as randomized. Lenses were removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period. | Lehfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only, as randomized. Lenses were removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period. | Total of all reporting groups |
| Overall Participants | 40 | 78 | 118 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
32.9
(7.3)
|
34.4
(7.6)
|
33.9
(7.5)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
31
77.5%
|
57
73.1%
|
88
74.6%
|
| Male |
9
22.5%
|
21
26.9%
|
30
25.4%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
2
5%
|
4
5.1%
|
6
5.1%
|
| Not Hispanic or Latino |
38
95%
|
74
94.9%
|
112
94.9%
|
| 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 |
1
2.5%
|
0
0%
|
1
0.8%
|
| Black or African American |
2
5%
|
12
15.4%
|
14
11.9%
|
| White |
36
90%
|
65
83.3%
|
101
85.6%
|
| More than one race |
0
0%
|
1
1.3%
|
1
0.8%
|
| Unknown or Not Reported |
1
2.5%
|
0
0%
|
1
0.8%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
40
100%
|
78
100%
|
118
100%
|
Outcome Measures
| Title | Distance VA (logMAR) With Study Lenses - Completed Eyes |
|---|---|
| Description | Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned. |
| Time Frame | Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up, Month 2 follow-up, Month 3 follow-up (at least 4 hours after lens insertion at each follow-up assessment visit) |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all enrolled and dispensed subjects/eyes that completed the study with data at corresponding in-person visit. |
| Arm/Group Title | Biofinity | LID018869 |
|---|---|---|
| Arm/Group Description | Comfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours onl, as randomized. Lenses were removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period. | Lehfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only, as randomized. Lenses were removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period. |
| Measure Participants | 38 | 77 |
| Measure eyes | 76 | 154 |
| Dispense |
-0.07
(0.06)
|
-0.07
(0.06)
|
| Week 1 follow-up |
-0.08
(0.06)
|
-0.07
(0.06)
|
| Week 2 follow-up Snellen |
-0.07
(0.06)
|
-0.07
(0.06)
|
| Month 1 follow-up |
-0.07
(0.06)
|
-0.07
(0.06)
|
| Month 2 follow-up |
-0.06
(0.06)
|
-0.07
(0.07)
|
| Month 3 follow-up |
-0.07
(0.06)
|
-0.06
(0.11)
|
| Title | Distance VA (logMAR) With Study Lenses - Discontinued Eyes |
|---|---|
| Description | Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned. |
| Time Frame | Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all enrolled and dispensed subjects/eyes that discontinued the study early with data at corresponding in-person visit. |
| Arm/Group Title | Biofinity | LID018869 |
|---|---|---|
| Arm/Group Description | Comfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours onl, as randomized. Lenses were removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period. | Lehfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only, as randomized. Lenses were removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period. |
| Measure Participants | 2 | 1 |
| Measure eyes | 4 | 2 |
| Dispense |
-0.06
(0.07)
|
0.00
(0.00)
|
| Week 1 follow-up |
-0.12
(0.00)
|
-0.12
(0.00)
|
| Week 2 follow-up |
0.00
(0.00)
|
-0.12
(0.00)
|
| Month 1 follow-up |
-0.12
(0.00)
|
Adverse Events
| Time Frame | Adverse events (AE's) were collected from time of consent to study exit, approximately 3 months. | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 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 enrolled and dispensed subjects. | |||||||||
| Arm/Group Title | Pre-treatment | LID018869 Ocular | LID018869 Nonocular/Systemic | Biofinity Ocular | Biofinity Nonocular/Systemic | |||||
| 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 lehfilcon A contact lenses | Events reported in this group occurred while exposed to lehfilcon A contact lenses | Events reported in this group occurred while exposed to comfilcon A contact lenses | Events reported in this group occurred while exposed to comfilcon A contact lenses | |||||
All Cause Mortality |
||||||||||
| Pre-treatment | LID018869 Ocular | LID018869 Nonocular/Systemic | Biofinity Ocular | Biofinity Nonocular/Systemic | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/118 (0%) | 0/156 (0%) | 0/78 (0%) | 0/80 (0%) | 0/40 (0%) | |||||
Serious Adverse Events |
||||||||||
| Pre-treatment | LID018869 Ocular | LID018869 Nonocular/Systemic | Biofinity Ocular | Biofinity Nonocular/Systemic | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/118 (0%) | 0/156 (0%) | 0/78 (0%) | 0/80 (0%) | 0/40 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| Pre-treatment | LID018869 Ocular | LID018869 Nonocular/Systemic | Biofinity Ocular | Biofinity Nonocular/Systemic | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/118 (0%) | 0/156 (0%) | 0/78 (0%) | 0/80 (0%) | 0/40 (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:
NCT04178720
Other Study ID Numbers:
- CLY935-C010
First Posted:
Nov 26, 2019
Last Update Posted:
Oct 19, 2021
Last Verified:
Sep 1, 2021