NCT05794126

A Clinical Comparison of Two Soft Multifocal Contact Lenses

Completed NA Results posted Last updated 10 April 2024

What this trial tests

NA trial testing Lens 1 in Presbyopia in 47 participants. Completed in 23 March 2023.

Timeline

1 February 2023

Primary endpoint
23 March 2023

23 March 2023

Quick facts

Lead sponsor	CooperVision, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	47
Start date	1 February 2023
Primary completion	23 March 2023
Estimated completion	23 March 2023
Sites	1 location across United Kingdom

Drugs / interventions tested

• Lens 1
• Lens 2

Conditions studied

• Presbyopia — all drugs for Presbyopia →

Sponsor

CooperVision, Inc.

Who can join

42 and older, 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.

Subjective Overall Score Primary · 15 Minutes

Subjective Overall Score was assessed using the 0-100 visual analogue scale where 0=Extremely poor, cannot use lenses and 100=Excellent=Highly impressed with these lenses overall

Group	Value	95% CI
Lens 1	71.4	± 18.0
Lens 2	80.3	± 14.7

Subjective Comfort Secondary · 15 Minutes

Subjective Comfort Score was assessed using the 0-100 visual analogue scale where 0=Extremely uncomfortable, causes pain, cannot be tolerated and 100=Excellent, cannot be felt

Group	Value	95% CI
Lens 1	75.0	± 20.9
Lens 2	88.9	± 12.2

Subjective Vision Secondary · 15 Minutes

Subjective Vision Score (distance and near) was assessed using the 0-100 visual analogue scale where 0=Unacceptable, cannot be worn and 100=Excellent, unaware of any visual loss

Distance Vision

Group	Value	95% CI
Lens 1	72.3	± 17.1
Lens 2	78.4	± 15.8

Near Vision

Group	Value	95% CI
Lens 1	77.4	± 18.2
Lens 2	79.6	± 15.7

Sponsor's own description

The study objective was to gather short-term clinical performance data for two soft multifocal contact lenses.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Human retinal secretome: A cross-link between mesenchymal and retinal cells.
   Donato L, Scimone C, Alibrandi S, Scalinci SZ, et al · · 2023 · cited 6× · PMID 37545752 · DOI 10.4252/wjsc.v15.i7.665