NCT05973409

Evaluation of Onefit Scleral Lenses in the Mangement of Dry Eye

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: CooperVision International Limited (CVIL) · Industry
• Sex: All
• Age: 17 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study is being conducted to determine if scleral lenses treated with Hydra-PEG improve comfort and dryness.

Detailed description

The objective of the study is to determine if scleral lenses with and scleral lenses without Hydra-PEG treatment provide positive improvement in ocular comfort and dryness scores. The effect of the study lenses and the treatment, will be compared in a group of symptomatic soft lens wearers, and also in a group of symptomatic non contact lens wearers. The primary outcome variable for this study is "overall ocular comfort" reported at the screening visit for the habitual vision correction, and at the 4-week follow-up visits for each of the two study lenses. using a 0-10 scale (0.5 steps).

Conditions

• Dry Eye

Interventions

Type	Name	Description
DEVICE	scleral lens	scleral lens with and without hydra-peg treatment

Timeline

• Start date: 2022-09-26
• Primary completion: 2023-08-15
• Completion: 2023-08-15
• First posted: 2023-08-02
• Last updated: 2026-04-17

Locations

1 site across 1 country: Canada