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Clinical Evaluation of Two Monthly Contact Lenses

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ClinicalTrials.gov Identifier: NCT03459131
Recruitment Status : Completed
First Posted : March 8, 2018
Results First Posted : March 5, 2019
Last Update Posted : March 5, 2019
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
Condition Refractive Errors
Interventions Device: Comfilcon A with Digital Zone Optics™ contact lenses
Device: Comfilcon A contact lenses
Enrollment 15
Recruitment Details Subjects were recruited from one study site located in the US.
Pre-assignment Details All 15 enrolled subjects were randomized and exposed to investigational product. This reporting group includes all randomized and treated subjects (15).
Arm/Group Title BIOFINITY ENERGYS Then BIOFINITY BIOFINITY Then BIOFINITY ENERGYS
Hide Arm/Group Description Comfilcon A with Digital Zone Optics™ contact lenses worn first, followed by comfilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for 7 days in a daily wear modality. Comfilcon A contact lenses worn first, followed by comfilcon A with Digital Zone Optics™ contact lenses. Each product will be worn bilaterally (in both eyes) for 7 days in a daily wear modality.
Period Title: Period 1, First 7 Days of Wear
Started 7 8
Completed 7 8
Not Completed 0 0
Period Title: Period 2, Second 7 Days of Wear
Started 7 8
Completed 7 8
Not Completed 0 0
Arm/Group Title Overall
Hide Arm/Group Description Comfilcon A with Digital Zone Optics™ contact lenses and comfilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized.
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study (Safety Analysis Set).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
28.3  (3.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
9
  60.0%
Male
6
  40.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
White
14
  93.3%
Black or African American
0
   0.0%
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Other
1
   6.7%
Multi-Racial
0
   0.0%
1.Primary Outcome
Title Subjective Rating of Overall Vision
Hide Description Overall vision was assessed binocularly (both eyes together) by the subject on a 10-point scale, where 1=poor and 10=excellent. Inferential testing was not planned for this primary effectiveness endpoint.
Time Frame Day 7, each product
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title BIOFINITY ENERGYS BIOFINITY
Hide Arm/Group Description:
Comfilcon A with Digital Zone Optics™ contact lenses worn during Period 1 or Period 2 for 7 days.
Comfilcon A contact lenses worn during Period 1 or Period 2 for 7 days.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.6  (1.2) 8.6  (1.1)
2.Secondary Outcome
Title Over-refraction
Hide Description Over-refraction (amount of additional correction needed to improve visual acuity (VA)) was collected for each eye and measured in diopters (D). Inferential testing was not planned for this endpoint.
Time Frame Day 1 (Dispense), each product
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title BIOFINITY ENERGYS BIOFINITY
Hide Arm/Group Description:
Comfilcon A with Digital Zone Optics™ contact lenses worn during Period 1 or Period 2 for 7 days.
Comfilcon A contact lenses worn during Period 1 or Period 2 for 7 days.
Overall Number of Participants Analyzed 15 15
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
30 30
Count of Units
Unit of Measure: Eyes
-0.25D
3
  10.0%
0
   0.0%
0.00D
26
  86.7%
24
  80.0%
+0.25D
1
   3.3%
6
  20.0%
Time Frame Dispense through study completion, an average of 14 days
Adverse Event Reporting Description An Adverse Event (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. Safety Analysis Set, based on treatment-specific exposure. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
 
Arm/Group Title BIOFINITY ENERGYS BIOFINITY
Hide Arm/Group Description All subjects exposed to comfilcon A with Digital Zone Optics™ contact lenses All subject exposed to comfilcon A contact lenses
All-Cause Mortality
BIOFINITY ENERGYS BIOFINITY
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
BIOFINITY ENERGYS BIOFINITY
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BIOFINITY ENERGYS BIOFINITY
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (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: Sr Clinical 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: NCT03459131     History of Changes
Other Study ID Numbers: CLD523-E001
First Submitted: March 2, 2018
First Posted: March 8, 2018
Results First Submitted: February 13, 2019
Results First Posted: March 5, 2019
Last Update Posted: March 5, 2019