Dehydration of Stenfilcon A Contact Lenses Versus Delefilcon A Contact Lenses
Study Details
Study Description
Brief Summary
The study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
The study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses. The primary outcome variable for this study is the loss in lens weight over the day, which will indicate the amount of dehydration that has occured.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: stenfilcon A Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design). |
Device: stenfilcon A
Each subject randomized to wear either the test or control in either the left of right eye.
Device: delefilcon A
Each subject randomized to wear either the test or control in either the left of right eye.
|
Active Comparator: delefilcon A Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design). |
Device: stenfilcon A
Each subject randomized to wear either the test or control in either the left of right eye.
Device: delefilcon A
Each subject randomized to wear either the test or control in either the left of right eye.
|
Outcome Measures
Primary Outcome Measures
- Absolute Change in Water Content (Mean) of Stenfilcon A and Delefilcon A [12 Hours of Wear]
Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).
- Absolute Change in Water Content (Median) of Stenfilcon A and Delefilcon A [12 Hours of Wear]
Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).
- Moisture Retention (Mean) of Stenfilcon A and Delefilcon A [12 Hours of Wear]
Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).
- Moisture Retention (Median) of Stenfilcon A and Delefilcon A [12 Hours of Wear]
Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).
Secondary Outcome Measures
- Subjective Comfort of Stenfilcon A and Delefilcon A [Up to 12 Hours of Wear]
Subjective ratings for stenfilcon A and delefilcon A assessed at every hour up to 12 hours. (Scale 0-100, 0=very poor 100=excellent)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Is at least 17 years of age and has full legal capacity to volunteer;
-
Has read and signed an information consent letter;
-
Is willing and able to follow instructions and maintain the appointment schedule;
-
Is a current wearer of soft contact lenses and has worn them (any brand) more than 3 months.
-
Is able to wear lenses for at least 12 hours a day.
Exclusion Criteria:
-
Is participating in any concurrent clinical study;
-
Has any known active* ocular disease and/or infection;
-
Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
-
Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
-
Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
-
Has undergone refractive error surgery;
- *For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Waterloo School of Optometry | Waterloo | Ontario | Canada | N2L 3G1 |
Sponsors and Collaborators
- Coopervision, Inc.
Investigators
- Principal Investigator: Lydon Jones, PhD FC, Director, Centre for Contact Lens Research
- Principal Investigator: Farah Panjwani, BSc RAQ, Univerisy of Waterloo
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EX-MKTG-56
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Overall Participants |
---|---|
Arm/Group Description | Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table. stenfilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table delefilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table |
Period Title: Overall Study | |
STARTED | 28 |
COMPLETED | 22 |
NOT COMPLETED | 6 |
Baseline Characteristics
Arm/Group Title | Overall Participants |
---|---|
Arm/Group Description | Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table. stenfilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table delefilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table |
Overall Participants | 22 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
27.1
(9.9)
|
Age (years) [Median (Full Range) ] | |
Median (Full Range) [years] |
25
|
Sex: Female, Male (Count of Participants) | |
Female |
16
72.7%
|
Male |
6
27.3%
|
Outcome Measures
Title | Absolute Change in Water Content (Mean) of Stenfilcon A and Delefilcon A |
---|---|
Description | Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC). |
Time Frame | 12 Hours of Wear |
Outcome Measure Data
Analysis Population Description |
---|
There were outliers across four participants in five lenses due to the fact that the weight of the worn lens after 12 hours was greater than the baseline weight of the lens from the blister pack. The sample size for statistical analysis is reduced to 18 pairs. |
Arm/Group Title | Stenfilcon A | Delefilcon A |
---|---|---|
Arm/Group Description | Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design). stenfilcon A: Each subject randomized to wear either the test or control in either the left of right eye. | Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design). delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye. |
Measure Participants | 18 | 18 |
Mean (Standard Deviation) [absolute WC change] |
2.82
(1.31)
|
2.91
(2.31)
|
Title | Subjective Comfort of Stenfilcon A and Delefilcon A |
---|---|
Description | Subjective ratings for stenfilcon A and delefilcon A assessed at every hour up to 12 hours. (Scale 0-100, 0=very poor 100=excellent) |
Time Frame | Up to 12 Hours of Wear |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Stenfilcon A | Delefilcon A |
---|---|---|
Arm/Group Description | Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design). stenfilcon A: Each subject randomized to wear either the test or control in either the left of right eye. | Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design). delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye. |
Measure Participants | 22 | 22 |
0 HR |
92.0
(11.5)
|
93.9
(8.4)
|
1 HR |
90.5
(8.4)
|
92.8
(8.6)
|
2 HR |
90.9
(8.8)
|
93.6
(6.2)
|
3 HR |
89.8
(10.9)
|
92.7
(7.0)
|
4 HR |
89.7
(9.3)
|
91.8
(8.0)
|
5 HR |
89.1
(9.5)
|
90.6
(8.4)
|
6 HR |
87.5
(10.4)
|
91.8
(7.8)
|
7 HR |
86.8
(10.4)
|
89.5
(10.0)
|
8 HR |
84.7
(10.5)
|
87.2
(10.7)
|
9 HR |
83.0
(11.6)
|
85.6
(12.6)
|
10 HR |
80.9
(12.0)
|
83.9
(13.4)
|
11 HR |
78.0
(14.8)
|
81.4
(15.2)
|
12 HR |
75.5
(16.2)
|
81.1
(14.7)
|
Title | Absolute Change in Water Content (Median) of Stenfilcon A and Delefilcon A |
---|---|
Description | Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC). |
Time Frame | 12 Hours of Wear |
Outcome Measure Data
Analysis Population Description |
---|
There were outliers across four participants in five lenses due to the fact that the weight of the worn lens after 12 hours was greater than the baseline weight of the lens from the blister pack. The sample size for statistical analysis is reduced to 18 pairs. |
Arm/Group Title | Stenfilcon A | Delefilcon A |
---|---|---|
Arm/Group Description | Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design). stenfilcon A: Each subject randomized to wear either the test or control in either the left of right eye. | Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design). delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye. |
Measure Participants | 18 | 18 |
Median (Full Range) [absolute WC change] |
2.76
|
2.35
|
Title | Moisture Retention (Mean) of Stenfilcon A and Delefilcon A |
---|---|
Description | Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD). |
Time Frame | 12 Hours of Wear |
Outcome Measure Data
Analysis Population Description |
---|
There were outliers across four participants in five lenses due to the fact that the weight of the worn lens after 12 hours was greater than the baseline weight of the lens from the blister pack. The sample size for statistical analysis is reduced to 18 pairs. |
Arm/Group Title | Stenfilcon A | Delefilcon A |
---|---|---|
Arm/Group Description | Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design). stenfilcon A: Each subject randomized to wear either the test or control in either the left of right eye. | Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design). delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye. |
Measure Participants | 18 | 18 |
Mean (Standard Deviation) [percentage of dehyrdation] |
5.22
(2.42)
|
9.21
(7.38)
|
Title | Moisture Retention (Median) of Stenfilcon A and Delefilcon A |
---|---|
Description | Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD). |
Time Frame | 12 Hours of Wear |
Outcome Measure Data
Analysis Population Description |
---|
There were outliers across four participants in five lenses due to the fact that the weight of the worn lens after 12 hours was greater than the baseline weight of the lens from the blister pack. The sample size for statistical analysis is reduced to 18 pairs. |
Arm/Group Title | Stenfilcon A | Delefilcon A |
---|---|---|
Arm/Group Description | Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design). stenfilcon A: Each subject randomized to wear either the test or control in either the left of right eye. | Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design). delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye. |
Measure Participants | 18 | 18 |
Median (Full Range) [percentage of dehyrdation] |
5.15
|
7.41
|
Adverse Events
Time Frame | From dispense up to 12 hours for each study lenses | |
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | Overall Participants | |
Arm/Group Description | Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table. stenfilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table delefilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table | |
All Cause Mortality |
||
Overall Participants | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
Overall Participants | ||
Affected / at Risk (%) | # Events | |
Total | 0/22 (0%) | |
Other (Not Including Serious) Adverse Events |
||
Overall Participants | ||
Affected / at Risk (%) | # Events | |
Total | 0/22 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Principal Investigators are NOT employed by the organization sponsoring the study. There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.
Results Point of Contact
Name/Title | Jose A. Vega, OD, Sr. Manager Global Medical Scientific Affairs |
---|---|
Organization | Coopervision |
Phone | (925) 621-3761 |
jvega@coopervision.com |
- EX-MKTG-56