Clinical Biocompatibility Evaluation of Contact Lens Coatings

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03034928
• Collaborator: (none)
• Enrollment: 33
• Location: 1
• Arms: 4
• Actual Duration (Days): 28
• Patients Per Site Per Month: 35.9

Study Details

Study Description

Brief Summary

The primary objective is to evaluate corneal staining observed after 2 hours of wear with contact lenses with investigational coating against PureVision™ lenses, all pre-cycled with OPTI-FREE® RepleniSH® multi-purpose disinfection solution.

Condition or Disease	Intervention/Treatment	Phase
Refractive Errors; Ametropia	Device: Contact lens with investigational coating 1; Device: Balafilcon A contact lens; Device: OPTI-FREE® RepleniSH® MPDS; Device: Contact lens with investigational coating 2	N/A

Detailed Description

In this contralateral crossover study, qualifying subjects will wear a total of 2 pairs of study contact lenses. Lenses will be worn according to a randomized lens sequence assignment. Each pair will consist of a test lens (Test 1 or Test 2) and a control lens.

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Clinical Biocompatibility Evaluation of Contact Lens Coatings
• Actual Study Start Date: Feb 14, 2017
• Actual Primary Completion Date: Mar 14, 2017
• Actual Study Completion Date: Mar 14, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: Test 1/Control 1, then Control 2/Test 2 Contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.	Device: Contact lens with investigational coating 1; Contact lens with investigational coating 1 pre-cycled in OPTI-FREE® RepleniSH® Multi-Purpose Disinfecting Solution (MPDS); Other Names: Test 1 ; Device: Balafilcon A contact lens; Balafilcon A contact lens pre-cycled OPTI-FREE® RepleniSH® MPDS; Other Names: Bausch & Lomb PureVision™ Control 1 Control 2 ; Device: OPTI-FREE® RepleniSH® MPDS; Multipurpose contact lens solution; Device: Contact lens with investigational coating 2; Contact lens with investigational coating 2 pre-cycled in OPTI-FREE® RepleniSH® MPDS; Other Names: Test 2
Other: Test 2/Control 2, then Control 1/Test 1 Contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.	Device: Contact lens with investigational coating 1; Contact lens with investigational coating 1 pre-cycled in OPTI-FREE® RepleniSH® Multi-Purpose Disinfecting Solution (MPDS); Other Names: Test 1 ; Device: Balafilcon A contact lens; Balafilcon A contact lens pre-cycled OPTI-FREE® RepleniSH® MPDS; Other Names: Bausch & Lomb PureVision™ Control 1 Control 2 ; Device: OPTI-FREE® RepleniSH® MPDS; Multipurpose contact lens solution; Device: Contact lens with investigational coating 2; Contact lens with investigational coating 2 pre-cycled in OPTI-FREE® RepleniSH® MPDS; Other Names: Test 2
Other: Control 1/Test 1, then Test 2/Control 2 Balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 1, followed by contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.	Device: Contact lens with investigational coating 1; Contact lens with investigational coating 1 pre-cycled in OPTI-FREE® RepleniSH® Multi-Purpose Disinfecting Solution (MPDS); Other Names: Test 1 ; Device: Balafilcon A contact lens; Balafilcon A contact lens pre-cycled OPTI-FREE® RepleniSH® MPDS; Other Names: Bausch & Lomb PureVision™ Control 1 Control 2 ; Device: OPTI-FREE® RepleniSH® MPDS; Multipurpose contact lens solution; Device: Contact lens with investigational coating 2; Contact lens with investigational coating 2 pre-cycled in OPTI-FREE® RepleniSH® MPDS; Other Names: Test 2
Other: Control 2/Test 2, then Test 1/Control 1 Balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 1, followed by contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.	Device: Contact lens with investigational coating 1; Contact lens with investigational coating 1 pre-cycled in OPTI-FREE® RepleniSH® Multi-Purpose Disinfecting Solution (MPDS); Other Names: Test 1 ; Device: Balafilcon A contact lens; Balafilcon A contact lens pre-cycled OPTI-FREE® RepleniSH® MPDS; Other Names: Bausch & Lomb PureVision™ Control 1 Control 2 ; Device: OPTI-FREE® RepleniSH® MPDS; Multipurpose contact lens solution; Device: Contact lens with investigational coating 2; Contact lens with investigational coating 2 pre-cycled in OPTI-FREE® RepleniSH® MPDS; Other Names: Test 2

Outcome Measures

Primary Outcome Measures

1. Average Percent Area of Solution-related Corneal Staining [Day 1 after 2 hours of wear, each product]

   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. A higher percentage reflects more damage to the corneal surface. Both eyes contributed to the analysis. 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

Inclusion Criteria:

• Able to understand and must sign an Informed Consent;

• Successful wearer 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 less than or equal to 1.50 diopter (D) in each eye;

• Best Corrected Visual Acuity (BCVA) 20/25 or better in each eye;

• VA with habitual spectacles 20/40 in both eyes (OU) or better and willing to wear spectacles as needed during the washout period and during study lens exposure;

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Any anterior segment infection, inflammation, abnormality or disease that contraindicates contact lens wear;

• Any use of systemic or ocular medications for which contact lens wear could be contraindicated;

• History of refractive surgery or plan to have refractive surgery during the study or irregular cornea in either eye;

• Ocular or intra-ocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;

• Current or history of pathologically dry eye in either eye that would preclude contact lens wear;

• Current or history of herpetic keratitis in either eye;

• Eye injury in either eye within 12 weeks immediately prior to enrollment;

• History of intolerance or hypersensitivity to any component of the study lenses or solutions;

• Habitual contact lenses worn in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;

• Use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;

• Other protocol-specified exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Investigative Site	Johns Creek	Georgia	United States	30097

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Sr. Clinical Manager, Trial Management Operations, Alcon, A Novartis Division

Study Documents (Full-Text)

• Study Protocol - Dec 9, 2016
• Statistical Analysis Plan - Jan 5, 2017

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT03034928
• Other Study ID Numbers: CLY935-E002
• First Posted: Jan 27, 2017
• Last Update Posted: Feb 18, 2020
• Last Verified: Feb 1, 2020

• 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
• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 1 study center located in the United States (US).
Pre-assignment Detail	All 33 subjects enrolled were randomized. This reporting group includes all randomized subjects (33).

Arm/Group Title	Test 1/Control 1, Then Control 2/Test 2	Test 2/Control 2, Then Control 1/Test 1	Control 1/Test 1, Then Test 2/Control 2	Control 2/Test 2, Then Test 1/Control 1
Arm/Group Description	Contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.	Contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.	Balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 1, followed by contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.	Balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 1, followed by contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
Period Title: Period 1, First 2 Hours of Wear
STARTED	8	8	9	8
COMPLETED	8	8	9	8
NOT COMPLETED	0	0	0	0
Period Title: Period 1, First 2 Hours of Wear
STARTED	8	8	9	8
COMPLETED	8	8	9	8
NOT COMPLETED	0	0	0	0
Period Title: Period 1, First 2 Hours of Wear
STARTED	8	8	9	8
COMPLETED	8	8	9	8
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	Contact lens with investigational coatings and balafilcon A contact lens worn contralaterally during Period 1 and Period 2.
Overall Participants	33
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.9 (14.46)
Sex: Female, Male (Count of Participants)
Female	26 78.8%
Male	7 21.2%
Race/Ethnicity, Customized (Count of Participants)
White	27 81.8%
Black or African American	5 15.2%
American Indian or Alaska Native	0 0%
Asian	1 3%
Native Hawaiian or Other Pacific Islander	0 0%
Multi-Racial	0 0%
Other	0 0%

Outcome Measures

1. Primary Outcome

Title	Average Percent Area of Solution-related Corneal Staining
Description	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. A higher percentage reflects more damage to the corneal surface. Both eyes contributed to the analysis. No hypotheses were formulated; no inferences were made and only descriptive statistics were used in the reporting.
Time Frame	Day 1 after 2 hours of wear, each product

Outcome Measure Data

Analysis Population Description

This analysis population includes all randomized subjects who satisfied protocol-specified criteria (Full Analysis Set).

Arm/Group Title	Test 1	Control 1	Test 2	Control 2
Arm/Group Description	Contact lens with investigational coating 1 worn for approximately 2 hours during Period 1 or Period 2	Balafilcon A contact lens worn contralaterally to Test 1 for approximately 2 hours during Period 1 or Period 2	Contact lens with investigational coating 2 worn for approximately 2 hours during Period 1 or Period 2	Balafilcon A contact lens worn contralaterally to Test 2 for approximately 2 hours during Period 1 or Period 2
Measure Participants	33	33	33	33
Mean (Standard Deviation) [percentage of area]	7.01 (10.54)	12.82 (17.93)	13.54 (17.20)	7.58 (10.34)

Adverse Events

Time Frame	Baseline through study completion, approximately 8 days
Adverse Event Reporting Description	An adverse event (AE) is 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. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Safety Analysis Set, based on treatment-specific exposure.
Arm/Group Title	Test 1		Test 2		Control
Arm/Group Description	All subjects exposed to contact lens with investigational coating 1 during Period 1 or Period 2		All subjects exposed to contact lens with investigational coating 2 during Period 1 or Period 2		All subjects exposed to balafilcon A contact lens during Period 1 or Period 2
All Cause Mortality
	Test 1		Test 2		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/33 (0%)		0/33 (0%)
Serious Adverse Events
	Test 1		Test 2		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/33 (0%)		0/33 (0%)
Other (Not Including Serious) Adverse Events
	Test 1		Test 2		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/33 (0%)		0/33 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.