- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03757039
Multifocal Visual Performance Study
March 10, 2020 updated by: Alcon Research
Multifocal Visual Performance Study - Seamless Transition With Precision Profile MF Lenses
The purpose of this trial was to compare the functional visual performance of Precision Profile Multifocal (MF) contact lenses to Progressive Addition Lens (PAL) spectacles in a presbyopic population.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Habitual contact lens wearers were randomized 1:1:1 to one of three commercially available multifocal contact lenses.
Progressive addition lens wearers wore their habitual spectacles.
Subjects were expected to attend 1 or 2 office visits.
This study was terminated early by Alcon due to slow enrollment and inconsistency in measurement of the primary endpoint.
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Birmingham, United Kingdom, B4 7ET
- Alcon Investigative Site
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Texas
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Houston, Texas, United States, 77204-2020
- Alcon Investigative Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
38 years to 58 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Normal eyes, other than correction for refractive error;
- Habitual correction of either any multifocal contact lens with a maximum add of +2.00 Diopter (D), or progressive addition lens spectacles with a maximum add of +2.00 D;
- Wears habitual correction at least 5 days per week and at least 6 hours per day.
Exclusion Criteria:
- Monocular subjects;
- Subjects fit with only one contact lens;
- Known pregnancy or lactating;
- History of or planned refractive surgery or irregular cornea in either eye.
Other protocol-specified inclusion and/or exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Multifocal Contact Lenses
Multifocal soft contact lenses according to the subject's prescription and fitted using the Alcon multifocal fitting guide.
Lenses were worn bilaterally (in both eyes) for up to 3 hours, 1 day only.
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Commercially available contact lenses
Other Names:
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Active Comparator: PAL Spectacles
Progressive addition lens spectacles according to the subject's habitual prescription, with testing up to 3 hours, 1 day only.
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Per subject's habitual prescription
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average Transition Time, Calculated From a Maximum of 3 Readings, Recorded in Seconds, During Alternate Viewing From Distance (4 m) to Intermediate (80 cm) and Vice Versa (Full Analysis Set)
Time Frame: Day 1, after up to 3 hours of wear
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The subject was asked to read text at distance (4 meters) or intermediate (80 centimeters), followed immediately by text at the alternate viewing (intermediate or distance).
The interval between when the subject stopped reading the first text and started reading the second text is defined as the transition time.
Due to inconsistent measurement of the primary endpoint in this study, interpretation of the average transition times was compromised and the planned inferential analysis was not carried out.
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Day 1, after up to 3 hours of wear
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Senior Clinical Manager, CDMA, Alcon Research, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 16, 2018
Primary Completion (Actual)
March 6, 2019
Study Completion (Actual)
March 6, 2019
Study Registration Dates
First Submitted
November 27, 2018
First Submitted That Met QC Criteria
November 27, 2018
First Posted (Actual)
November 28, 2018
Study Record Updates
Last Update Posted (Actual)
March 25, 2020
Last Update Submitted That Met QC Criteria
March 10, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLT792-P001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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