Multifocal Visual Performance Study - Seamless Transition With Precision Profile MF Lenses
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Presbyopia
- Sponsor
- Alcon Research
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- 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)
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief 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.
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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
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.