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Multifocal High ADD Contact Lens Proof of Concept Trial

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ClinicalTrials.gov Identifier: NCT02117544
Recruitment Status : Completed
First Posted : April 21, 2014
Results First Posted : August 17, 2015
Last Update Posted : August 26, 2015
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Presbyopia
Interventions Device: Lotrafilcon B multifocal contact lenses (new)
Device: Lotrafilcon B multifocal contact lenses
Enrollment 268
Recruitment Details Subjects were recruited from 7 study centers located in the US.
Pre-assignment Details Of the 268 enrolled, 159 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (109).
Arm/Group Title New MF, Then AOAMF AOAMF, Then New MF
Hide Arm/Group Description Lotrafilcon B multifocal contact lenses (new), followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally for about 1 hour. Lotrafilcon B multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses (new). Each product worn bilaterally for about 1 hour.
Period Title: Period 1
Started 54 55
Treated 52 55
Completed 52 55
Not Completed 2 0
Reason Not Completed
Lost to follow-up (prior to treatment)             2             0
Period Title: Period 2
Started 52 55
Completed 52 55
Not Completed 0 0
Arm/Group Title Overall
Hide Arm/Group Description AIR OPTIX® AQUA Multifocal and lotrafilcon B Multifocal (new design) contact lenses worn during Period 1 and Period 2 in a crossover assignment.
Overall Number of Baseline Participants 107
Hide Baseline Analysis Population Description
This analysis population includes all randomized and treated subjects.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 107 participants
57.6  (5.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants
Female
91
  85.0%
Male
16
  15.0%
1.Primary Outcome
Title High Contrast Visual Acuity (HCVA) Near Monocular
Hide Description Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 40 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.
Time Frame Day 1, 10 minutes after lens insertion, each product
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).
Arm/Group Title New MF AOAMF
Hide Arm/Group Description:
Lotrafilcon B multifocal (new design) contact lenses worn during Period 1 or Period 2 for 1 hour
Lotrafilcon B multifocal contact lenses worn during Period 1 or Period 2 for 1 hour
Overall Number of Participants Analyzed 104 104
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
208 208
Least Squares Mean (Standard Error)
Unit of Measure: logMAR
0.18  (0.02) 0.32  (0.02)
2.Secondary Outcome
Title HCVA Distance Monocular
Hide Description Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 6 meters using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.
Time Frame Day 1, 10 minutes after lens insertion, each product
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).
Arm/Group Title New MF AOAMF
Hide Arm/Group Description:
Lotrafilcon B multifocal (new design) contact lenses worn during Period 1 or Period 2 for 1 hour
Lotrafilcon B multifocal contact lenses worn during Period 1 or Period 2 for 1 hour
Overall Number of Participants Analyzed 104 104
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
208 208
Least Squares Mean (Standard Error)
Unit of Measure: logMAR
0.11  (0.01) 0.06  (0.01)
3.Secondary Outcome
Title HCVA Intermediate Monocular
Hide Description Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 1 meter using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.
Time Frame Day 1, 10 minutes after lens insertion, each product
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).
Arm/Group Title New MF AOAMF
Hide Arm/Group Description:
Lotrafilcon B multifocal (new design) contact lenses worn during Period 1 or Period 2 for 1 hour
Lotrafilcon B multifocal contact lenses worn during Period 1 or Period 2 for 1 hour
Overall Number of Participants Analyzed 104 104
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
208 208
Least Squares Mean (Standard Error)
Unit of Measure: logMAR
0.04  (0.01) 0.02  (0.01)
4.Secondary Outcome
Title Low Contrast Visual Acuity (LCVA) Distance Monocular
Hide Description Visual Acuity (clarity or sharpness of vision) was measured at low contrast level. LCVA was assessed monocularly (each eye separately) at 6 meters using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.
Time Frame Day 1, 10 minutes after lens insertion, each product
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).
Arm/Group Title New MF AOAMF
Hide Arm/Group Description:
Lotrafilcon B multifocal (new design) contact lenses worn during Period 1 or Period 2 for 1 hour
Lotrafilcon B multifocal contact lenses worn during Period 1 or Period 2 for 1 hour
Overall Number of Participants Analyzed 104 104
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
208 208
Least Squares Mean (Standard Error)
Unit of Measure: logMAR
0.44  (0.01) 0.39  (0.01)
Time Frame Adverse events (AEs) were collected for the duration of the study (3 months). AEs are reported as pre-treatment and treatment-emergent, based on treatment-specific exposure.
Adverse Event Reporting Description An 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 as solicited comments from subjects and as observations by the study Investigator as outlined in the study protocol.
 
Arm/Group Title Pre-treatment New MF AOAMF
Hide Arm/Group Description Includes all enrolled subjects/eyes prior to exposure to the investigational products Includes all subjects/eyes exposed to New MF Includes all subjects/eyes exposed to AOAMF
All-Cause Mortality
Pre-treatment New MF AOAMF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pre-treatment New MF AOAMF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/268 (0.00%)   0/107 (0.00%)   0/107 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pre-treatment New MF AOAMF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/268 (0.00%)   0/107 (0.00%)   0/107 (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
Name/Title: Clinical Project Lead, Vision Care, GCRA
Organization: Alcon Research, Ltd
Phone: 1-888-451-3937
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02117544     History of Changes
Other Study ID Numbers: C-13-057
First Submitted: April 16, 2014
First Posted: April 21, 2014
Results First Submitted: July 21, 2015
Results First Posted: August 17, 2015
Last Update Posted: August 26, 2015