Multifocal Visual Performance Study

Presbyopia Clinical Trial

Official title:

Multifocal Visual Performance Study - Seamless Transition With Precision Profile MF Lenses

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03757039
• Other study ID #: CLT792-P001
• Status: Terminated
• Phase: N/A
• Start date: December 16, 2018
• Est. completion date: March 6, 2019

Study information

• Verified date: March 2020
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: March 6, 2019
• Est. primary completion date: March 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 38 Years to 58 Years

Eligibility

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.

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• Multifocal soft contact lenses
Commercially available contact lenses

Other:
• Progressive addition lens spectacles
Per subject's habitual prescription

Locations

Country	Name	City	State
United Kingdom	Alcon Investigative Site	Birmingham
United States	Alcon Investigative Site	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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.	Day 1, after up to 3 hours of wear