Formula Identification (FID) 114657 in Contact Lens Wearers

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02293538
• Collaborator: (none)
• Enrollment: 234
• Arms: 2
• Duration (Months): 8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Refractive Error	Drug: FID 114657 eye drops (10 ml); Drug: Saline control eye drops (15 ml); Device: Habitual contact lenses	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 234 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Official Title: Evaluation of a Lubricant Eye Drop on Tear Lipid Layer Thickness in Contact Lens Wearers
• Study Start Date: Nov 1, 2014
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FID 114657 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.	Drug: FID 114657 eye drops (10 ml); Lubricating eye drop for temporary relief of burning and irritation due to dryness of the eye; Device: Habitual contact lenses; Commercially marketed biweekly or monthly replacement soft contact lenses as prescribed by eye care practitioner, brand and power
Active Comparator: 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.	Drug: Saline control eye drops (15 ml); Saline eye drops (15 ml); Device: Habitual contact lenses; Commercially marketed biweekly or monthly replacement soft contact lenses as prescribed by eye care practitioner, brand and power

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Clinical Manager, Pharmaceuticals, Global Medical Affairs, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02293538
• Other Study ID Numbers: LCO242-P001
• First Posted: Nov 18, 2014
• Last Update Posted: Oct 6, 2016
• Last Verified: Aug 1, 2016

• Keywords provided by Alcon Research: Symptoms of Contact Lens Related Discomfort
• Additional relevant MeSH terms: Refractive Errors; Ophthalmic Solutions

Study Results

Participant Flow

Recruitment Details	A total of 234 participants were recruited from 6 investigational centers located in the United States.
Pre-assignment Detail	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).

Arm/Group Title	Saline Control	FID 114657
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	73	71
COMPLETED	72	69
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	Saline Control	FID 114657	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	74	72	146
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.3 (12.25)	38.3 (12.36)	36.2 (12.43)
Age, Customized (participants) [Number]
18-64 years	73 98.6%	71 98.6%	144 98.6%
≥ 65 years	1 1.4%	1 1.4%	2 1.4%
Sex: Female, Male (Count of Participants)
Female	58 78.4%	65 90.3%	123 84.2%
Male	16 21.6%	7 9.7%	23 15.8%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Intention to treat participants with non-missing observations

Arm/Group Title	Saline Control	FID 114657
Arm/Group Description	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.	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.
Measure Participants	72	71
Mean (Standard Deviation) [ICU]	61.2 (21.48)	61.5 (21.47)

2. Secondary Outcome

Title	Mean Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) at Baseline and Day 14
Description	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.
Time Frame	Baseline (Day 0), Day 14

Outcome Measure Data

Analysis Population Description

Intention to treat participants with non-missing observations

Arm/Group Title	FID 114657
Arm/Group Description	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.
Measure Participants	71
Baseline (n=69)	7.43 (3.28)
Day 14 (n=70)	10.69 (3.53)

3. Secondary Outcome

Title	Percentage of Participants That Experienced At Least 1 Unit Increase From Baseline Score to Day 14 for Overall Comfort With Lenses
Description	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.
Time Frame	Baseline (Day 0), Day 14

Outcome Measure Data

Analysis Population Description

Intention to treat participants with non-missing observations

Arm/Group Title	Saline Control	FID 114657
Arm/Group Description	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.	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.
Measure Participants	71	68
Number [percentage of participants]	84.5 114.2%	79.4 110.3%

4. Secondary Outcome

Title	Mean Change From Baseline in Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) to Day 14
Description	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.
Time Frame	Baseline (Day 0), Day 14

Outcome Measure Data

Analysis Population Description

Intention to treat participants with non-missing observations

Arm/Group Title	Saline Control	FID 114657
Arm/Group Description	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.	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.
Measure Participants	71	68
Mean (Standard Deviation) [hours]	3.12 (3.72)	3.28 (3.31)

5. Secondary Outcome

Title	Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 14
Description	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 14, after 2 hours of lens wear

Outcome Measure Data

Analysis Population Description

Intention to treat participants with non-missing observations

Arm/Group Title	Saline Control	FID 114657
Arm/Group Description	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.	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.
Measure Participants	72	69
Mean (Standard Deviation) [ICU]	58.5 (21.09)	59.4 (19.30)

Adverse Events

Time Frame	Reporting of adverse events (AEs) began once informed consent was obtained from the participant, and continued through Day 14. This analysis population includes all participants exposed to any test or control article evaluated in this study.
Adverse Event Reporting Description	An Adverse Event (AE) was any untoward medical occurrence in a participant who was administered a study treatment (i.e., initiation of treatment with test article) regardless of whether or not the event has a causal relationship with the treatment. Solicited and spontaneous AE reports were collected for both eyes combined.
Arm/Group Title	Saline Control		FID 114657
Arm/Group Description	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.		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.
All Cause Mortality
	Saline Control		FID 114657
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Saline Control		FID 114657
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/74 (0%)		0/72 (0%)
Other (Not Including Serious) Adverse Events
	Saline Control		FID 114657
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/74 (0%)		0/72 (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.