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Management Decision
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multifocal Contact Lenses | Experimental | 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. |
|
| PAL Spectacles | Active Comparator | Progressive addition lens spectacles according to the subject's habitual prescription, with testing up to 3 hours, 1 day only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multifocal soft contact lenses | Device | Commercially available contact lenses |
|
| 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) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-specified inclusion and/or exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Senior Clinical Manager, CDMA | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | Houston | Texas | 77204-2020 | United States | ||
| Alcon Investigative Site |
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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).
Subjects were enrolled at investigative sites located in the United States (1) and United Kingdom (1).
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| ID | Title | Description |
|---|---|---|
| FG000 | Multifocal Contact Lenses | All subjects randomized to multifocal contact lenses (AOHG MF, DT1 MF, or DACP MF) |
| FG001 | PAL Spectacles Wearers | All subjects assigned to progressive addition lens (PAL) spectacles |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This analysis population includes all subjects exposed to any study product evaluated in this study, except for the lenses used at Visit 2 for the purpose of parameter optimization and fitting, as they are not intended for the assessment of safety (Safety Analysis Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | AOHG MF | All subjects randomized to AOHG MF |
| BG001 | DT1 MF | All subjects randomized to DT1 MF |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Mean | Standard Deviation | seconds | Day 1, after up to 3 hours of wear |
|
Adverse events were collected from time of enrollment until study exit, typically up to approximately 14 days.
This analysis population includes all subjects exposed to any study product evaluated in this study, except for the lenses used at Visit 2 for the purpose of parameter optimization and fitting, as they are not intended for the assessment of safety (Safety Analysis Set).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AOHG MF | All subjects exposed to AOHG MF | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blurred Vision | Eye disorders | MedDRA 21.0 | Systematic Assessment |
Due to inconsistent measurement of the primary endpoint in this study, interpretation of the average transition times was compromised.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. CDMA Project Lead, Vision Care | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 19, 2018 | Mar 9, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 29, 2019 | Mar 9, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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This was a double-masked trial for the contact lens wearers. The PAL wearers were not masked.
| Progressive addition lens spectacles | Other | Per subject's habitual prescription |
|
|
| Birmingham |
| B4 7ET |
| United Kingdom |
| BG002 |
| DACP MF |
All subjects randomized to DACP MF |
| BG003 | PALs | All subjects assigned to PALs |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Multifocal Contact Lenses |
Multifocal soft contact lenses (AOHG MF, DACP MF, DT1 MF combined) 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. |
| OG001 | PAL Spectacles | Progressive addition lens spectacles according to the subject's habitual prescription, with testing up to 3 hours, 1 day only. |
|
|
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | DT1 MF | All subjects exposed to DT1 MF | 0 | 11 | 0 | 11 | 0 | 11 |
| EG002 | DACP MF | All subjects exposed to DACP MF | 0 | 10 | 0 | 10 | 0 | 10 |
| EG003 | PALs | All subjects exposed to PALs | 0 | 9 | 0 | 9 | 1 | 9 |
| Sinusitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Blood glucose abnormal | Investigations | MedDRA 21.0 | Systematic Assessment |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.