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Assessing Fitting Guides in Alcon Multifocal Contact Lenses

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ClinicalTrials.gov Identifier: NCT03118934
Recruitment Status : Completed
First Posted : April 18, 2017
Results First Posted : September 26, 2018
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Other
Conditions Presbyopia
Refractive Errors
Interventions Device: Lotrafilcon B multifocal contact lenses
Device: Nelfilcon A multifocal contact lenses
Device: Delefilcon A multifocal contact lenses
Enrollment 188
Recruitment Details Subjects were recruited from 20 investigational sites located in the United States (14), United Kingdom (3), and Canada (3).
Pre-assignment Details Of the 188 enrolled subjects, 6 were exited prior to trial fit. This reporting group includes all subjects randomized and trial fit, as randomized (182). Safety Analysis Set is reported as exposed.
Arm/Group Title AOA MF - Alternative DACP MF - Alternative DT1 MF - Alternative AOA MF - Current DACP MF - Current DT1 MF - Current
Hide Arm/Group Description Bilaterally (in both eyes) fitted using alternative fitting guide; lotrafilcon B multifocal contact lenses worn bilaterally for 10 ± 3 days Bilaterally fitted using alternative fitting guide; nelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days Bilaterally fitted using alternative fitting guide; delefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days Bilaterally fitted using current fitting guide; lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 10 ± 3 days Bilaterally fitted using current fitting guide; nelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days Bilaterally fitted using current fitting guide; delefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days
Period Title: Overall Study
Started [1] 34 31 34 29 29 25
Safety Analysis Set [2] 34 29 34 29 26 25
Completed [3] 34 30 33 28 27 23
Not Completed 0 1 1 1 2 2
Reason Not Completed
Adverse Event             0             0             0             0             0             1
Physician Decision             0             0             0             0             0             1
Discontinued prior to exposure             0             1             1             1             2             0
[1]
Randomized and trial fit, as randomized
[2]
All subjects/eyes exposed to study lenses, except those used for trial fit at Visit 1, as exposed
[3]
Completed, as randomized
Arm/Group Title AOA MF DACP MF DT1 MF Total
Hide Arm/Group Description Lotrafilcon B multifocal contact lenses worn bilaterally for 10 ± 3 days Nelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days Delefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days Total of all reporting groups
Overall Number of Baseline Participants 63 55 59 177
Hide Baseline Analysis Population Description
Safety Analysis Set. Baseline data analyzed based on study lens.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 63 participants 55 participants 59 participants 177 participants
50.6  (6.9) 50.1  (6.7) 50.1  (6.7) 50.3  (6.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 55 participants 59 participants 177 participants
Female
51
  81.0%
46
  83.6%
52
  88.1%
149
  84.2%
Male
12
  19.0%
9
  16.4%
7
  11.9%
28
  15.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 55 participants 59 participants 177 participants
White
55
  87.3%
48
  87.3%
51
  86.4%
154
  87.0%
Black or African American
2
   3.2%
4
   7.3%
0
   0.0%
6
   3.4%
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
5
   7.9%
2
   3.6%
6
  10.2%
13
   7.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Other
1
   1.6%
1
   1.8%
2
   3.4%
4
   2.3%
1.Primary Outcome
Title Mean Number of Trial Lenses Needed to Fit Each Eye
Hide Description The Investigator used a multi-focal contact lens fitting guide to determine which study lens to fit
Time Frame VIsit 1/Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects randomized or assigned to study lenses as applicable, and exposed to study lenses including trial fit at Visit 1 (Full Analysis Set).
Arm/Group Title Alternative Current
Hide Arm/Group Description:
Bilaterally fitted with trial lenses using the alternative fitting guide
Bilaterally fitted with trial lenses using the current fitting guide
Overall Number of Participants Analyzed 99 83
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
198 166
Mean (Standard Deviation)
Unit of Measure: lenses
1.2  (0.5) 1.4  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alternative, Current
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The pre-specified non-inferiority margin is 0.5. With a sample size of 80/group, there was approximately 83% power to reject the null hypothesis of inferiority in fit with assumed standard deviation of 0.6 and expected difference of 0.25 (one-sided alpha=0.05).
Method of Estimation Estimation Parameter LSM Difference
Estimated Value -0.2
Confidence Interval (1-Sided) 95%
-0.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.06
Estimation Comments [Not Specified]
Time Frame Screening/Fitting through study completion, a maximum of 33 days.
Adverse Event Reporting Description Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set, as exposed, which is different than "as randomized" due to subjects not following the assigned randomization. "At risk" population for ocular AEs is reported in units of eyes.
 
Arm/Group Title AOA MF Ocular AOA MF Nonocular DACP MF Ocular DACP MF Nonocular DT1 MF Ocular DT1 MF Nonocular
Hide Arm/Group Description Eyes exposed to AIR OPTIX AQUA® Multifocal (AOA MF) contact lenses Subjects exposed to AOA MF contact lenses Eyes exposed to DAILIES® AquaComfort Plus® Multifocal (DACP MF) contact lenses Subjects exposed to DACP MF contact lenses Eyes exposed to DAILIES TOTAL1® Multifocal (DT1 MF) contact lenses Subjects exposed to DT1 MF contact lenses
All-Cause Mortality
AOA MF Ocular AOA MF Nonocular DACP MF Ocular DACP MF Nonocular DT1 MF Ocular DT1 MF Nonocular
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/126 (0.00%)   0/63 (0.00%)   0/110 (0.00%)   0/55 (0.00%)   0/118 (0.00%)   0/59 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
AOA MF Ocular AOA MF Nonocular DACP MF Ocular DACP MF Nonocular DT1 MF Ocular DT1 MF Nonocular
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/126 (0.00%)   0/63 (0.00%)   0/110 (0.00%)   0/55 (0.00%)   0/118 (0.00%)   0/59 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AOA MF Ocular AOA MF Nonocular DACP MF Ocular DACP MF Nonocular DT1 MF Ocular DT1 MF Nonocular
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/126 (0.00%)   0/63 (0.00%)   0/110 (0.00%)   0/55 (0.00%)   0/118 (0.00%)   0/59 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Head, CDMA Vision Care Franchise
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: NCT03118934     History of Changes
Other Study ID Numbers: CLK027-P001
First Submitted: April 11, 2017
First Posted: April 18, 2017
Results First Submitted: July 3, 2018
Results First Posted: September 26, 2018
Last Update Posted: September 26, 2018