Presbyopia
Conditions
Keywords
contact lenses, multifocal, spectacles, glasses, progressive, vision, eyes
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.
Interventions
Commercially available contact lenses
OTHERProgressive addition lens spectacles
Per subject's habitual prescription
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
This was a double-masked trial for the contact lens wearers. The PAL wearers were not masked.
Eligibility
Sex/Gender
ALL
Age
38 Years to 58 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
Countries
United Kingdom, United States
Participant flow
Recruitment details
Subjects were enrolled at investigative sites located in the United States (1) and United Kingdom (1).
Pre-assignment details
Of the 42 enrolled, 1 subject was exited from the study as a screen failure prior to randomization. This reporting group includes all randomized/assigned subjects (41).
Participants by arm
| Arm | Count |
|---|---|
| AOHG MF All subjects randomized to AOHG MF | 11 |
| DT1 MF All subjects randomized to DT1 MF | 11 |
| DACP MF All subjects randomized to DACP MF | 10 |
| PALs All subjects assigned to PALs | 9 |
| Total | 41 |
Baseline characteristics
| Characteristic | AOHG MF | Total | PALs | DACP MF | DT1 MF |
|---|---|---|---|---|---|
| Age, Continuous | 52.1 years STANDARD_DEVIATION 4.1 | 52.0 years STANDARD_DEVIATION 3.8 | 51.7 years STANDARD_DEVIATION 3.6 | 51.9 years STANDARD_DEVIATION 4 | 52.5 years STANDARD_DEVIATION 4.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 8 Participants | 5 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 1 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 26 Participants | 3 Participants | 7 Participants | 8 Participants |
| Sex: Female, Male Female | 5 Participants | 24 Participants | 5 Participants | 6 Participants | 8 Participants |
| Sex: Female, Male Male | 6 Participants | 17 Participants | 4 Participants | 4 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 | 0 / 10 | 0 / 9 |
| other Total, other adverse events | 0 / 11 | 0 / 11 | 0 / 10 | 1 / 9 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 | 0 / 10 | 0 / 9 |
Outcome results
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.
Time frame: Day 1, after up to 3 hours of wear
Population: This analysis population includes all subjects assigned to PALs or randomized to the contact lens group who were exposed to any study product evaluated in this study, except for the lenses used for optimization and fitting (Full Analysis Set).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Multifocal Contact Lenses | 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) | 2.602 seconds | Standard Deviation 1.136 |
| PAL Spectacles | 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) | 2.774 seconds | Standard Deviation 0.839 |