Three Daily Wear Monthly Replacement Silicone Hydrogel Contact Lenses With Two Multi-purpose Disinfecting Solution Combinations

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04789382
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 4
• Actual Duration (Days): 30
• Patients Per Site Per Month: 36.5

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate corneal staining observed after 2 hours of wear with an investigational contact lens against both PureVision contact lenses pre-cycled with Biotrue and Biofinity contact lenses pre-cycled with RepleniSH.

Condition or Disease	Intervention/Treatment	Phase
Refractive Errors	Device: LID018869+RepleniSH; Device: LID018869+Biotrue; Device: Biofinity+RepleniSH; Device: PV+Biotrue	N/A

Detailed Description

Subjects will be randomized in a 1:1:1:1 manner to receive one of 4 regimen sequences with lens and multipurpose disinfection solution (MPDS) combinations. The expected duration of subject participation in the study is approximately 1 week with 2 study visit days.

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Clinical Biocompatibility of Three Daily Wear Monthly Replacement Silicone Hydrogel Contact Lenses With Two Multi-purpose Disinfecting Solution Combinations
• Actual Study Start Date: Apr 7, 2021
• Actual Primary Completion Date: May 7, 2021
• Actual Study Completion Date: May 7, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Sequence 1 LID018869+RepleniSH in the right eye and Biofinity+RepleniSH in the left eye (first wear period), followed by PV+Biotrue in the right eye and LID018869+Biotrue in the left eye (second wear period). Each wear period will be 2 hours.	Device: LID018869+RepleniSH; Lehfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with OPTI-FREE® RepleniSH® multi-purpose disinfecting solution (RepleniSH); Device: LID018869+Biotrue; Lehfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with Biotrue® multi-purpose solution (Biotrue); Device: Biofinity+RepleniSH; Comfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with OPTI-FREE® RepleniSH® multi-purpose disinfecting solution (RepleniSH); Device: PV+Biotrue; Balafilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with Biotrue® multi-purpose solution (Biotrue)
Other: Sequence 2 Biofinity+RepleniSH in the right eye and LID018869+RepleniSH in the left eye (first wear period), followed by LID018869+Biotrue in the right eye and PV+Biotrue in the left eye (second wear period). Each wear period will be 2 hours.	Device: LID018869+RepleniSH; Lehfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with OPTI-FREE® RepleniSH® multi-purpose disinfecting solution (RepleniSH); Device: LID018869+Biotrue; Lehfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with Biotrue® multi-purpose solution (Biotrue); Device: Biofinity+RepleniSH; Comfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with OPTI-FREE® RepleniSH® multi-purpose disinfecting solution (RepleniSH); Device: PV+Biotrue; Balafilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with Biotrue® multi-purpose solution (Biotrue)
Other: Sequence 3 LID018869+Biotrue in the right eye and PV+Biotrue in the left eye (first wear period), followed by Biofinity+RepleniSH in the right eye and LID018869+RepleniSH in the left eye (second wear period). Each wear period will be 2 hours.	Device: LID018869+RepleniSH; Lehfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with OPTI-FREE® RepleniSH® multi-purpose disinfecting solution (RepleniSH); Device: LID018869+Biotrue; Lehfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with Biotrue® multi-purpose solution (Biotrue); Device: Biofinity+RepleniSH; Comfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with OPTI-FREE® RepleniSH® multi-purpose disinfecting solution (RepleniSH); Device: PV+Biotrue; Balafilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with Biotrue® multi-purpose solution (Biotrue)
Other: Sequence 4 PV+Biotrue in the right eye and LID018869+Biotrue in the left eye (first wear period), followed by LID018869+RepleniSH in the right eye and Biofinity+RepleniSH the left eye (second wear period). Each wear period will be 2 hours.	Device: LID018869+RepleniSH; Lehfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with OPTI-FREE® RepleniSH® multi-purpose disinfecting solution (RepleniSH); Device: LID018869+Biotrue; Lehfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with Biotrue® multi-purpose solution (Biotrue); Device: Biofinity+RepleniSH; Comfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with OPTI-FREE® RepleniSH® multi-purpose disinfecting solution (RepleniSH); Device: PV+Biotrue; Balafilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with Biotrue® multi-purpose solution (Biotrue)

Outcome Measures

Primary Outcome Measures

1. Average Percent Area of Corneal Staining [Hour 2 (each wear period)]

   A slit lamp examination was performed by the investigator to assess corneal staining. Percent of solution-related corneal staining area was assessed first in each of the 5 corneal regions: central, superior, nasal, inferior, and temporal. The average of corneal staining area was then calculated as the average over all 5 regions. Each eye was treated differently and was graded separately. No hypotheses were formulated; no inferences were made, and only descriptive statistics were used in the reporting.

Eligibility Criteria

Criteria

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

Key Inclusion Criteria:

• Understand and sign an Informed Consent;

• Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;

• Manifest cylinder of less than or equal to 1.50 diopter (D) in each eye;

• Best corrected visual acuity (BCVA) better than or equal to 20/25 Snellen in each eye;

• Willing to stop wearing habitual contact lenses for the duration of study lens exposure and during the washout period.

• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• Any eye condition or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator;

• Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;

• Eye surgery, as specified in the protocol;

• Dry eye; use of artificial tears, as specified in the protocol;

• Other protocol-specified exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Investigator 6565	Maitland	Florida	United States	32751

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Clinical Trial Lead, Vision Care, Alcon Research, LLC

Study Documents (Full-Text)

• Study Protocol - Mar 29, 2021
• Statistical Analysis Plan - Mar 31, 2021

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT04789382
• Other Study ID Numbers: CLY935-E007
• First Posted: Mar 9, 2021
• Last Update Posted: May 25, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Alcon Research: contact lens; contact lens solution
• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from one investigative site located in the United States.
Pre-assignment Detail	This reporting group includes all enrolled subjects.

Arm/Group Title	Sequence 1	Sequence 2	Sequence 3	Sequence 4
Arm/Group Description	LID018869+RepleniSH in the right eye and Biofinity+RepleniSH in the left eye (first wear period), followed by PV+Biotrue in the right eye and LID018869+Biotrue in the left eye (second wear period). Each wear period was 2 hours.	Biofinity+RepleniSH in the right eye and LID018869+RepleniSH in the left eye (first wear period), followed by LID018869+Biotrue in the right eye and PV+Biotrue in the left eye (second wear period). Each wear period was be 2 hours.	LID018869+Biotrue in the right eye and PV+Biotrue in the left eye (first wear period), followed by Biofinity+RepleniSH in the right eye and LID018869+RepleniSH in the left eye (second wear period). Each wear period was 2 hours.	PV+Biotrue in the right eye and LID018869+Biotrue in the left eye (first wear period), followed by LID018869+RepleniSH in the right eye and Biofinity+RepleniSH the left eye (second wear period). Each wear period was 2 hours.
Period Title: First Wear Period (2 Hours)
STARTED	9	9	9	9
COMPLETED	9	9	9	9
NOT COMPLETED	0	0	0	0
Period Title: First Wear Period (2 Hours)
STARTED	9	9	9	9
COMPLETED	9	9	9	9
NOT COMPLETED	0	0	0	0
Period Title: First Wear Period (2 Hours)
STARTED	9	9	9	9
COMPLETED	9	9	9	9
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Sequence 1	Sequence 2	Sequence 3	Sequence 4	Total
Arm/Group Description	LID018869+RepleniSH in the right eye and Biofinity+RepleniSH in the left eye (first wear period), followed by PV+Biotrue in the right eye and LID018869+Biotrue in the left eye (second wear period). Each wear period was 2 hours.	Biofinity+RepleniSH in the right eye and LID018869+RepleniSH in the left eye (first wear period), followed by LID018869+Biotrue in the right eye and PV+Biotrue in the left eye (second wear period). Each wear period was 2 hours.	LID018869+Biotrue in the right eye and PV+Biotrue in the left eye (first wear period), followed by Biofinity+RepleniSH in the right eye and LID018869+RepleniSH in the left eye (second wear period). Each wear period was 2 hours.	PV+Biotrue in the right eye and LID018869+Biotrue in the left eye (first wear period), followed by LID018869+RepleniSH in the right eye and Biofinity+RepleniSH the left eye (second wear period). Each wear period was 2 hours.	Total of all reporting groups
Overall Participants	9	9	9	9	36
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.7 (5.4)	29.0 (5.9)	36.0 (6.8)	31.6 (6.3)	31.8 (6.4)
Sex: Female, Male (Count of Participants)
Female	6 66.7%	7 77.8%	6 66.7%	8 88.9%	27 75%
Male	3 33.3%	2 22.2%	3 33.3%	1 11.1%	9 25%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 11.1%	1 11.1%	2 22.2%	0 0%	4 11.1%
Not Hispanic or Latino	8 88.9%	8 88.9%	7 77.8%	9 100%	32 88.9%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	1 11.1%	0 0%	1 2.8%
White	9 100%	9 100%	8 88.9%	9 100%	35 97.2%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	9 100%	9 100%	9 100%	9 100%	36 100%

Outcome Measures

1. Primary Outcome

Title	Average Percent Area of Corneal Staining
Description	A slit lamp examination was performed by the investigator to assess corneal staining. Percent of solution-related corneal staining area was assessed first in each of the 5 corneal regions: central, superior, nasal, inferior, and temporal. The average of corneal staining area was then calculated as the average over all 5 regions. Each eye was treated differently and was graded separately. No hypotheses were formulated; no inferences were made, and only descriptive statistics were used in the reporting.
Time Frame	Hour 2 (each wear period)

Outcome Measure Data

Analysis Population Description

Safety Analysis Set

Arm/Group Title	LID018869+RepleniSH	Biofinity+RepleniSH	LID018869+Biotrue	PV+Biotrue
Arm/Group Description	LID018869+RepleniSH worn for 2 hours in the right eye or left eye and during Period 1 or Period 2, as randomized	Biofinity+RepleniSH worn for 2 hours in the right eye or left eye and during Period 1 or Period 2, as randomized	LID018869+Biotrue worn for 2 hours in the right eye or left eye and during Period 1 or Period 2, as randomized	PV+Biotrue worn for 2 hours in the right eye or left eye and during Period 1 or Period 2, as randomized
Measure Participants	36	36	36	36
Measure eyes	36	36	36	36
Mean (Standard Deviation) [percentage of area]	2.93 (8.86)	0.45 (1.03)	6.06 (14.75)	3.52 (11.87)

Adverse Events

Time Frame	Adverse events (AE's) were collected from time of consent to study exit, approximately 1 week.
Adverse Event Reporting Description	An AE was defined at any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of pretreatment and non-ocular AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Arm/Group Title	Pretreatment		LID018869+RepleniSH Ocular		Biofinity+RepleniSH Ocular		LID018869+Biotrue Ocular		PV+Biotrue Ocular		All Nonocular
Arm/Group Description	Events reported in this group occurred prior to exposure to the study contact lenses		Events reported in this group occurred while exposed to the study contact lenses		Events reported in this group occurred while exposed to the study contact lenses		Events reported in this group occurred while exposed to the study contact lenses		Events reported in this group occurred while exposed to the study contact lenses		Events reported in this group occurred while left and right eyes were exposed to different study lenses as per randomized regimen sequence
All Cause Mortality
	Pretreatment		LID018869+RepleniSH Ocular		Biofinity+RepleniSH Ocular		LID018869+Biotrue Ocular		PV+Biotrue Ocular		All Nonocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/36 (0%)		0/36 (0%)		0/36 (0%)		0/36 (0%)		0/36 (0%)
Serious Adverse Events
	Pretreatment		LID018869+RepleniSH Ocular		Biofinity+RepleniSH Ocular		LID018869+Biotrue Ocular		PV+Biotrue Ocular		All Nonocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/36 (0%)		0/36 (0%)		0/36 (0%)		0/36 (0%)		0/36 (0%)
Other (Not Including Serious) Adverse Events
	Pretreatment		LID018869+RepleniSH Ocular		Biofinity+RepleniSH Ocular		LID018869+Biotrue Ocular		PV+Biotrue Ocular		All Nonocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/36 (0%)		0/36 (0%)		0/36 (0%)		0/36 (0%)		0/36 (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.