Trial Outcomes & Findings for Formula Identification (FID) 114657 in Contact Lens Wearers (NCT NCT02293538)
NCT ID: NCT02293538
Last Updated: 2016-10-06
Results Overview
The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The anterior-most layer of the pre-lens tear film consists of lipids. Lipid layer thickness (LLT) is measured with the LipiView® Interferometer. LLT is measured in interferometric color units (ICUs), where 1 ICU reflects about 1 nanometer (nm) lipid layer thickness. Higher values of LLT indicate a better lubrication of the ocular surface. A thicker tear lipid layer helps reduce evaporation and is indicative of a more stable tear film. The right eye only was used for this measure.
COMPLETED
NA
234 participants
Day 1, after 2 hours of lens wear
2016-10-06
Participant Flow
A total of 234 participants were recruited from 6 investigational centers located in the United States.
Of the 234 enrolled, 84 participants were exited from the study as screen failures and 6 participants were discontinued prior to randomization. This reporting group includes all randomized and treated participants (Intent to Treat) (144).
Participant milestones
| Measure |
Saline Control
Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
|
FID 114657
Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
71
|
|
Overall Study
COMPLETED
|
72
|
69
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Saline Control
Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
|
FID 114657
Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Formula Identification (FID) 114657 in Contact Lens Wearers
Baseline characteristics by cohort
| Measure |
Saline Control
n=74 Participants
Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
|
FID 114657
n=72 Participants
Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.3 years
STANDARD_DEVIATION 12.25 • n=5 Participants
|
38.3 years
STANDARD_DEVIATION 12.36 • n=7 Participants
|
36.2 years
STANDARD_DEVIATION 12.43 • n=5 Participants
|
|
Age, Customized
18-64 years
|
73 participants
n=5 Participants
|
71 participants
n=7 Participants
|
144 participants
n=5 Participants
|
|
Age, Customized
≥ 65 years
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1, after 2 hours of lens wearPopulation: Intention to treat participants with non-missing observations
The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The anterior-most layer of the pre-lens tear film consists of lipids. Lipid layer thickness (LLT) is measured with the LipiView® Interferometer. LLT is measured in interferometric color units (ICUs), where 1 ICU reflects about 1 nanometer (nm) lipid layer thickness. Higher values of LLT indicate a better lubrication of the ocular surface. A thicker tear lipid layer helps reduce evaporation and is indicative of a more stable tear film. The right eye only was used for this measure.
Outcome measures
| Measure |
Saline Control
n=72 Participants
Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
|
FID 114657
n=71 Participants
Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
|
|---|---|---|
|
Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 1
|
61.2 ICU
Standard Deviation 21.48
|
61.5 ICU
Standard Deviation 21.47
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 14Population: Intention to treat participants with non-missing observations
At Baseline and on Day 14, comfort was collected through participant questionnaires regarding average and comfortable wear time. Participants filled in what time of day (over the past three days) they usually inserted their lenses, removed them, and at what time they usually became uncomfortable, or if they remained comfortable all day. Comfortable wear time was calculated as Time Uncomfortable minus Time Insertion. The participant rated both eyes together by providing one single rating. This outcome measure was prespecified for only FID 114657.
Outcome measures
| Measure |
Saline Control
n=71 Participants
Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
|
FID 114657
Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
|
|---|---|---|
|
Mean Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) at Baseline and Day 14
Baseline (n=69)
|
7.43 hours
Standard Deviation 3.28
|
—
|
|
Mean Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) at Baseline and Day 14
Day 14 (n=70)
|
10.69 hours
Standard Deviation 3.53
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 14Population: Intention to treat participants with non-missing observations
Overall comfort was rated by the participant on a 10-point scale, where 1=Poor and 10=Excellent, at Day 0 for their habitual lenses and at Day 14 for the lenses worn for the study during use of the assigned drop regimen. A 1-unit increase indicates improvement. The participant rated both eyes together by providing one single rating.
Outcome measures
| Measure |
Saline Control
n=71 Participants
Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
|
FID 114657
n=68 Participants
Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
|
|---|---|---|
|
Percentage of Participants That Experienced At Least 1 Unit Increase From Baseline Score to Day 14 for Overall Comfort With Lenses
|
84.5 percentage of participants
|
79.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 14Population: Intention to treat participants with non-missing observations
At Baseline and on Day 14, comfort was collected through participant questionnaires regarding average and comfortable wear time. Participants filled in what time of day (over the past three days) they usually inserted their lenses, removed them, and at what time they usually became uncomfortable, or if they remained comfortable all day. Comfortable wear time was calculated as Time Uncomfortable minus Time Insertion. A positive change from Baseline indicates improvement. The participant rated both eyes together by providing one single rating.
Outcome measures
| Measure |
Saline Control
n=71 Participants
Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
|
FID 114657
n=68 Participants
Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
|
|---|---|---|
|
Mean Change From Baseline in Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) to Day 14
|
3.12 hours
Standard Deviation 3.72
|
3.28 hours
Standard Deviation 3.31
|
SECONDARY outcome
Timeframe: Day 14, after 2 hours of lens wearPopulation: Intention to treat participants with non-missing observations
The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The anterior-most layer of the pre-lens tear film consists of lipids. Lipid layer thickness (LLT) is measured with the LipiView® Interferometer. LLT is measured in interferometric color units (ICUs), where 1 ICU reflects about 1 nanometer (nm) lipid layer thickness. Higher values of LLT indicate a better lubrication of the ocular surface. A thicker tear lipid layer helps reduce evaporation and is indicative of a more stable tear film. The right eye only was used for this measure.
Outcome measures
| Measure |
Saline Control
n=72 Participants
Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
|
FID 114657
n=69 Participants
Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
|
|---|---|---|
|
Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 14
|
58.5 ICU
Standard Deviation 21.09
|
59.4 ICU
Standard Deviation 19.30
|
Adverse Events
Saline Control
FID 114657
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 Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER