A Comparative Study of Two Daily Disposable Contact Lenses in Higher Myopia Subjects

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02066922
• Collaborator: (none)
• Enrollment: 19
• Arms: 2
• Duration (Months): 2

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the change from baseline in central corneal curvature at one week, between 2 silicone hydrogel lenses, in higher myopic subjects.

Condition or Disease	Intervention/Treatment	Phase
Refractive Error; Myopia	Device: Delefilcon A contact lens; Device: Narafilcon A contact lens; Device: Spectacles	N/A

Detailed Description

Participants were expected to attend 4 office visits. Visit 1 was the Screening/Enrollment visit. At Visit 2 (Baseline Visit), participants were randomized and the study lenses were trial fit. At Visit 3 (Dispense Visit), participants received study lenses for approximately 1 week of wear. Visit 4 was the Exit visit. Expected duration of participation in the study was 3 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DAILIES TOTAL1 Delefilcon A contact lens randomly assigned to one eye, with narafilcon A contact lens in the fellow eye for contralateral wear. Both products worn in a daily wear, daily disposable mode approximately 8 hours a day for approximately 1 week, with spectacles worn over contact lenses if needed to provide acceptable vision.	Device: Delefilcon A contact lens; Commercially available silicone hydrogel contact lens; Other Names: DAILIES® TOTAL1® ; Device: Narafilcon A contact lens; Commercially available silicone hydrogel contact lens; Other Names: 1-DAY ACUVUE TRUEYE™ ; Device: Spectacles; Incremental prescription worn over contact lenses if needed to provide acceptable vision
Active Comparator: TRUEYE Narafilcon A contact lens randomly assigned to one eye, with delefilcon A contact lens in the fellow eye for contralateral wear. Both products worn in a daily wear, daily disposable mode approximately 8 hours a day for approximately 1 week, with spectacles worn over contact lenses if needed to provide acceptable vision.	Device: Delefilcon A contact lens; Commercially available silicone hydrogel contact lens; Other Names: DAILIES® TOTAL1® ; Device: Narafilcon A contact lens; Commercially available silicone hydrogel contact lens; Other Names: 1-DAY ACUVUE TRUEYE™ ; Device: Spectacles; Incremental prescription worn over contact lenses if needed to provide acceptable vision

Outcome Measures

Primary Outcome Measures

1. Change in Average Central Corneal Curvature From Dispense at Week 1 [Dispense (Day 1 of lens wear), Week 1 (Day 8 of lens wear)]

   Corneal curvature (horizontal and vertical keratometry values on the same eye) was measured using a calibrated keratometer prior to study lens dispense (Day 1) and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Minus values in change-from-baseline indicate corneal flattening.

Secondary Outcome Measures

1. Number of Eyes With Change of >1.00 Diopter (D) in Spherical Equivalent of Subjective Refraction From Baseline at Week 1 [Baseline, Week 1 (Day 8 of lens wear)]

   Subjective manifest refraction was assessed using a phoropter or trial frame set with the subject's current prescription at Baseline (Visit 2) after a 2-day washout period and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Spectacle over-refraction, if required, was performed. Higher myopia is indicated by larger negative values in manifest refraction.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Sign Informed Consent document;

• Higher degree of myopia in both eyes, i.e. habitual contact lens power between -10.00 diopters (D) and -17.00D;

• Best corrected distance visual acuity greater than or equal to 20/30 in each eye (measured with either spectacle refraction or habitual contact lenses plus over refraction);

• Manifest astigmatism less than or equal to -1.00D;

• Soft contact lens wear in both eyes at least 5 days per week and at least 8 hours per day;

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Pregnant or lactating;

• Eye injury or surgery within twelve weeks immediately prior to enrollment;

• Any ocular condition that contraindicates contact lens wear;

• History of herpetic keratitis;

• Any use of systemic or ocular medications for which contact lens wear could be contraindicated, including any use of topical ocular medications that would require instillation during contact lens wear, except for approved lubricating drops;

• Clinical significant dry eye not responding to treatment;

• Previous corneal or refractive surgery or irregular cornea;

• Requires reading glasses;

• Participation in a clinical trial (including contact lens or contact lens care product) within the previous 30 days;

• Wears habitual lenses in an extended wear modality (routinely sleeps in lenses overnight for 1 night per week or more) over the last 3 months prior to enrollment;

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Joachim Nick, Dipl. Ing., Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02066922
• Other Study ID Numbers: C-12-057
• First Posted: Feb 20, 2014
• Last Update Posted: Jun 8, 2015
• Last Verified: May 1, 2015

• Keywords provided by Alcon Research: Contact lenses; Nearsightedness; Corneal curvature; K-reading; High minus; Spectacle refraction
• Additional relevant MeSH terms: Myopia; Refractive Errors

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 2 study centers located in the US and 2 study centers located in Germany.
Pre-assignment Detail	Of the 19 enrolled, 4 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (15).

Arm/Group Title	DAILIES TOTAL1/TRUEYE
Arm/Group Description	Delefilcon A and narafilcon A contact lenses (1 in each eye) worn in a daily wear, daily disposable mode approximately 8 hours a day for approximately 1 week.
Period Title: Overall Study
STARTED	15
COMPLETED	14
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	DAILIES TOTAL1/TRUEYE
Arm/Group Description	Delefilcon A and narafilcon A contact lenses (1 in each eye) worn in a daily wear, daily disposable mode approximately 8 hours a day for approximately 1 week.
Overall Participants	15
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.2 (8.7)
Sex: Female, Male (Count of Participants)
Female	10 66.7%
Male	5 33.3%

Outcome Measures

1. Primary Outcome

Title	Change in Average Central Corneal Curvature From Dispense at Week 1
Description	Corneal curvature (horizontal and vertical keratometry values on the same eye) was measured using a calibrated keratometer prior to study lens dispense (Day 1) and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Minus values in change-from-baseline indicate corneal flattening.
Time Frame	Dispense (Day 1 of lens wear), Week 1 (Day 8 of lens wear)

Outcome Measure Data

Analysis Population Description

This analysis group includes all randomized participants with data present at visit.

Arm/Group Title	DAILIES TOTAL1	TRUEYE
Arm/Group Description	Delefilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week	Narafilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week.
Measure Participants	14	14
Mean (Standard Deviation) [diopters]	-0.44 (0.46)	-0.11 (0.26)

2. Secondary Outcome

Title	Number of Eyes With Change of >1.00 Diopter (D) in Spherical Equivalent of Subjective Refraction From Baseline at Week 1
Description	Subjective manifest refraction was assessed using a phoropter or trial frame set with the subject's current prescription at Baseline (Visit 2) after a 2-day washout period and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Spectacle over-refraction, if required, was performed. Higher myopia is indicated by larger negative values in manifest refraction.
Time Frame	Baseline, Week 1 (Day 8 of lens wear)

Outcome Measure Data

Analysis Population Description

This analysis group includes all randomized participants with data present at visit.

Arm/Group Title	DAILIES TOTAL1	TRUEYE
Arm/Group Description	Delefilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week.	Narafilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week.
Measure Participants	14	14
Number [Eyes]	3	1

Adverse Events

Time Frame	Adverse events (AEs) were collected for the duration of the study (March, 2014 - May, 2014). This analysis group includes all participants/eyes exposed to the study products. Trial-fit lenses were not considered study products.
Adverse Event Reporting Description	An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device.
Arm/Group Title	DAILIES TOTAL1		TRUEYE
Arm/Group Description	Delefilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week		Narafilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week
All Cause Mortality
	DAILIES TOTAL1		TRUEYE
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	DAILIES TOTAL1		TRUEYE
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	DAILIES TOTAL1		TRUEYE
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/15 (26.7%)		1/15 (6.7%)
Eye disorders
Foreign body sensation in eyes	1/15 (6.7%)		0/15 (0%)
Metamorphopsia	1/15 (6.7%)		1/15 (6.7%)
Ocular discomfort	1/15 (6.7%)		0/15 (0%)
Punctate keratitis	1/15 (6.7%)		0/15 (0%)
Investigations
Topography corneal abnormal	1/15 (6.7%)		0/15 (0%)
Musculoskeletal and connective tissue disorders
Myokymia	1/15 (6.7%)		1/15 (6.7%)

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.