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Comparison of Two Silicone Hydrogel Toric Contact Lenses

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ClinicalTrials.gov Identifier: NCT03392532
Recruitment Status : Completed
First Posted : January 8, 2018
Results First Posted : January 29, 2019
Last Update Posted : January 29, 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: Other
Condition Astigmatism
Interventions Device: Lotrafilcon B toric contact lenses with HYDRAGLYDE
Device: Lotrafilcon B toric contact lenses
Enrollment 36
Recruitment Details Subjects were recruited from one investigative site located in the US.
Pre-assignment Details This reporting group includes all enrolled subjects (36).
Arm/Group Title AOHG Toric, Then AO Toric AO Toric, Then AOHG Toric
Hide Arm/Group Description Lotrafilcon B toric contact lenses with HYDRAGLYDE®, followed by lotrafilcon B toric contact lenses, as randomized. Each product worn in both eyes for approximately 30 minutes, with a 30-45 minute washout between the removal of Pair 1 and insertion of Pair 2. Lotrafilcon B toric contact lenses, followed by lotrafilcon B toric contact lenses with HYDRAGLYDE®, as randomized. Each product worn in both eyes for approximately 30 minutes, with a 30-45 minute washout between the removal of Pair 1 and insertion of Pair 2.
Period Title: Period 1, FIrst 30 Minutes of Wear
Started [1] 18 18
Completed 18 18
Not Completed 0 0
[1]
As randomized
Period Title: Period 2, Second 30 Minutes of Wear
Started [1] 18 18
Completed 18 18
Not Completed 0 0
[1]
As randomized
Arm/Group Title Overall
Hide Arm/Group Description Lotrafilcon B toric contact lenses with HYDRAGLYDE® and lotrafilcon B toric contact lenses worn during Period 1 and Period 2 in a crossover assignment
Overall Number of Baseline Participants 36
Hide Baseline Analysis Population Description
This analysis population includes all randomized subjects exposed to any study lenses evaluated in this study (Full Analysis Set).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants
51.5  (13.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
29
  80.6%
Male
7
  19.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
   8.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
6
  16.7%
White
27
  75.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Percentage of Lenses With Axis Orientation Within ±30 Degrees From the 90 Degree Axis (Ideal Location)
Hide Description Each lens was classified based on whether the absolute difference between the axis location and 90° was less than or equal to 30° (ie, lens axis located between the 60° and 120° axis inclusive). Inferential testing was not planned for this primary effectiveness endpoint.
Time Frame Day 1, 10 minutes after lens insertion, each product
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title AOHG Toric AO Toric
Hide Arm/Group Description:
Lotrafilcon B toric contact lenses with HYDRAGLYDE® worn in both eyes for approximately 30 minutes during either Period 1 or Period 2, as randomized
Lotrafilcon B toric contact lenses worn in both eyes for approximately 30 minutes in either Period 1 or Period 2, as randomized
Overall Number of Participants Analyzed 36 36
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
72 72
Measure Type: Number
Unit of Measure: percentage of lenses
94.4 95.8
Time Frame Dispense through study completion, approximately 2 hours
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. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the protocol. This analysis population includes all subjects/eyes exposed to any study lenses evaluated.
 
Arm/Group Title AOHG Toric AO Toric
Hide Arm/Group Description All subjects exposed to lotrafilcon B toric contact lenses with HYDRAGLYDE® in Period 1 or Period 2, as randomized All subjects exposed to lotrafilcon B toric contact lenses in Period 1 or Period 2, as randomized
All-Cause Mortality
AOHG Toric AO Toric
Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/36 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
AOHG Toric AO Toric
Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/36 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AOHG Toric AO Toric
Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/36 (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: CDMA Project Lead, CDMA 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: NCT03392532     History of Changes
Other Study ID Numbers: CLC127-C001
First Submitted: January 2, 2018
First Posted: January 8, 2018
Results First Submitted: January 7, 2019
Results First Posted: January 29, 2019
Last Update Posted: January 29, 2019