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NCT05252871

Assessment of Three Basic Progressive Lens Designs

Completed NA Results posted Last updated 15 August 2024
What this trial tests

NA trial testing Progressive Additional Lenses (PAL), pre calibrated and made of polymeric material with anti-reflection coating in Presbyopia in 80 participants. Completed in 6 June 2022.

Timeline
9 December 2021
Primary endpoint
6 June 2022
6 June 2022

Quick facts

Lead sponsorWestern University of Health Sciences
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment80
Start date9 December 2021
Primary completion6 June 2022
Estimated completion6 June 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Western University of Health Sciences

Who can join

Adults 45 to 70, any sex, with Presbyopia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Evaluate the Adaptation to Progressive Lens Designs. Primary · Entire study duration (approx. 4 weeks)

Evaluate the adaptation to progressive lens designs through a "Satisfaction questionnaire" after 1 week of use of each of the 3 progressive addition lenses. Scale titles: Visual Quality Scale: A 5-point scale from a minimum value of 1 to a maximum score of 5. Higher scores mean better outcomes.

GroupValue95% CI
Experimental: The Specified PAL Design Wearers, Wearing Pair 14.125± 0.822
The Other PAL Design Wearers, Wearing Pair 14.025± 1.05
Experimental: The Specified PAL Design Wearers, Wearing Pair 23.875± 0.992
The Other PAL Design Wearers, Wearing Pair 23.725± 0.987
Experimental: The Specified PAL Design Wearers, Wearing Pair 34.300± 0.939
The Other PAL Design Wearers, Wearing Pair 34.150± 0.864
Evaluate the Immediate Preference Among Progressive Lens Designs. Secondary · Directly after receiving the lenses (approx. 15 minutes)

Evaluate the immediate preference for progressive lens designs through a "Satisfaction questionnaire" directly after receiving the 3 progressive addition lenses. Scale titles: Visual Quality Scale: A 5-point scale from a minimum value of 1 to a maximum score of 5. Higher scores mean better outcomes.

GroupValue95% CI
Experimental: The Specified PAL Design Wearers, Wearing Pair 14.550± 0.714
The Other PAL Design Wearers, Wearing Pair 14.400± 0.709
Experimental: The Specified PAL Design Wearers, Wearing Pair 24.625± 0.667
The Other PAL Design Wearers, Wearing Pair 24.450± 0.783
Experimental: The Specified PAL Design Wearers, Wearing Pair 34.625± 0.568
The Other PAL Design Wearers, Wearing Pair 34.400± 0.672
Evaluate the Preference of Progressive Lens Designs. Secondary · Entire study duration (approx. 4 weeks)

Evaluate the final preference of progressive lens designs after wearing each of the 3 PALs for one week. Scale title: Preference of Progressive Addition Lenses Scale: "Pair 1", "Pair 2, "Pair 3"

GroupValue95% CI
Experimental: The Specified PAL Design Wearers, Wearing Pair 111
The Other PAL Design Wearers, Wearing Pair 116
Experimental: The Specified PAL Design Wearers, Wearing Pair 210
The Other PAL Design Wearers, Wearing Pair 29
Experimental: The Specified PAL Design Wearers, Wearing Pair 319
The Other PAL Design Wearers, Wearing Pair 315

Sponsor's own description

This clinical trial investigates the differences between three different progressive addition lens designs. It is a non-invasive double-masked randomized clinical investigation. For this study, 80 participants will be recruited.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Progressive Additional Lenses (PAL), pre calibrated and made of polymeric material with anti-reflection coating

Trials testing the same drug.

Other recruiting trials for Presbyopia

Currently open trials in the same condition.

Other Western University of Health Sciences trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05252871.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing