Formula Identification (FID) 114657 in Contact Lens Wearers

Evaluation of a Lubricant Eye Drop on Tear Lipid Layer Thickness in Contact Lens Wearers

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02293538

Enrollment

234

Registered

2014-11-18

Start date

2014-11-30

Completion date

2015-07-31

Last updated

2016-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractive Error

Keywords

Symptoms of Contact Lens Related Discomfort

Brief summary

The purpose of this study is to evaluate the thickness of the pre-lens tear lipid layer after 2 hours of lens wear with use of FID 114657 compared to saline control.

Interventions

DRUGFID 114657 eye drops (10 ml)

Lubricating eye drop for temporary relief of burning and irritation due to dryness of the eye

DRUGSaline control eye drops (15 ml)

Saline eye drops (15 ml)

DEVICEHabitual contact lenses

Commercially marketed biweekly or monthly replacement soft contact lenses as prescribed by eye care practitioner, brand and power

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Must sign the informed consent form. * Stable, tear lipid layer thickness ≤ 75 nm without contact lenses. * Successfully wearing bi-weekly or monthly replacement soft contact lenses in both eyes for a minimum of 5 days/week during the past 2 months prior to Visit 1. * Vision correctable to 20/25 Snellen (feet) or better at distance with habitual contact lenses at Visit 1. * Willing to wear lenses 5 days a week, 8 hours a day for at least 2 days during the study. * Demonstrate symptoms of contact lens discomfort. * Other protocol-defined inclusion criteria may apply.

Exclusion criteria

* Routinely sleeping in lenses. * Any active eye inflammation or condition that contraindicates contact lens wear. * Any systemic diseases that could prevent successful contact lens wear. * Use of systemic or ocular medications that contraindicate lens wear. * Fit with only 1 contact lens. * Unwilling to discontinue the use of cosmetics (such as eyeliner, mascara, or eye shadow) or facial creams on or around the eyelids on Day 1 and Day 14 of the study. * Women of childbearing potential who are currently pregnant, test positive for pregnancy at Screening visit, breast feeding, or unwilling to use adequate birth control throughout the study. * Other protocol-defined

Design outcomes

Primary

Measure	Time frame	Description
Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 1	Day 1, after 2 hours of lens wear	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.

Secondary

Measure	Time frame	Description
Mean Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) at Baseline and Day 14	Baseline (Day 0), Day 14	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.
Percentage of Participants That Experienced At Least 1 Unit Increase From Baseline Score to Day 14 for Overall Comfort With Lenses	Baseline (Day 0), Day 14	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.
Mean Change From Baseline in Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) to Day 14	Baseline (Day 0), Day 14	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.
Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 14	Day 14, after 2 hours of lens wear	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.

Participant flow

Recruitment details

A total of 234 participants were recruited from 6 investigational centers located in the United States.

Pre-assignment details

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).

Participants by arm

Arm	Count
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.	74
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.	72
Total	146

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	0	1
Overall Study	Lost to Follow-up	1	0
Overall Study	Withdrawal by Subject	0	1

Baseline characteristics

Characteristic	Saline Control	FID 114657	Total
Age, Continuous	34.3 years STANDARD_DEVIATION 12.25	38.3 years STANDARD_DEVIATION 12.36	36.2 years STANDARD_DEVIATION 12.43
Age, Customized 18-64 years	73 participants	71 participants	144 participants
Age, Customized ≥ 65 years	1 participants	1 participants	2 participants
Sex: Female, Male Female	58 Participants	65 Participants	123 Participants
Sex: Female, Male Male	16 Participants	7 Participants	23 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 74	0 / 72
serious Total, serious adverse events	0 / 74	0 / 72

Outcome results

Primary

Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 1

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.

Time frame: Day 1, after 2 hours of lens wear