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Clinical Biocompatibility Evaluation of Contact Lens Coatings

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03034928
Recruitment Status : Completed
First Posted : January 27, 2017
Results First Posted : February 18, 2020
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Refractive Errors
Ametropia
Interventions Device: Contact lens with investigational coating 1
Device: Balafilcon A contact lens
Device: OPTI-FREE® RepleniSH® MPDS
Device: Contact lens with investigational coating 2
Enrollment 33
Recruitment Details Subjects were recruited from 1 study center located in the United States (US).
Pre-assignment Details 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
Hide 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 [1] 8 8 9 8
Completed 8 8 9 8
Not Completed 0 0 0 0
[1]
Started = Randomized
Period Title: Washout Period Between Lens Wear
Started 8 8 9 8
Completed 8 8 9 8
Not Completed 0 0 0 0
Period Title: Period 2, Second 2 Hours of Wear
Started 8 8 9 8
Completed 8 8 9 8
Not Completed 0 0 0 0
Arm/Group Title Overall
Hide Arm/Group Description Contact lens with investigational coatings and balafilcon A contact lens worn contralaterally during Period 1 and Period 2.
Overall Number of Baseline Participants 33
Hide Baseline Analysis Population Description
This analysis population includes all subjects exposed to any study lens (Safety Analysis Set).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants
46.9  (14.46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female 26
Male 7
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
White 27
Black or African American 5
American Indian or Alaska Native 0
Asian 1
Native Hawaiian or Other Pacific Islander 0
Multi-Racial 0
Other 0
1.Primary Outcome
Title Average Percent Area of Solution-related Corneal Staining
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 33 33 33 33
Mean (Standard Deviation)
Unit of Measure: percentage of area
7.01  (10.54) 12.82  (17.93) 13.54  (17.20) 7.58  (10.34)
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
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/33 (0.00%)   0/33 (0.00%) 
Hide Serious Adverse Events
Test 1 Test 2 Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/33 (0.00%)   0/33 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Test 1 Test 2 Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/33 (0.00%)   0/33 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sr CDMA Project Lead, GCRA - Vision Care
Organization: Alcon, A Novartis Division
Phone: 1-888-451-3937
EMail: Alcon.medinfo@alcon.com
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT03034928    
Other Study ID Numbers: CLY935-E002
First Submitted: January 25, 2017
First Posted: January 27, 2017
Results First Submitted: February 5, 2020
Results First Posted: February 18, 2020
Last Update Posted: February 18, 2020