NCT05438615

Corneal Refractive Therapy Design Comparison for -4 to -6 Diopter Treatment for Overnight Wear for Myopia

A Prospective Study to Compare Lenses Having Two Different Proximity Control Designs for Overnight Wear for Treatment of Naturally Occurring Myopia From -4 to -6 Diopters Sphere With Refractive Astigmatism up to -1.75 Diopters

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: CooperVision International Limited (CVIL) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to compare the effectiveness of two proximity control geometry lens designs to treat eyes with pretreatment myopia between -4.00 and -6.00 D myopia with and without refractive astigmatism in a modality involving overnight wearing.

Detailed description

Each subject shall undergo a comprehensive eye examination to determine eligibility. Subjects must meet all eligibility criteria. All eyes shall be treated with two pair of the proximity control lenses by the qualified clinical investigator. The first pair shall be dispensed and scheduled follow-up examinations shall be conducted at one day, one week, and two weeks after dispensing lenses. Each subject shall then cease wearing lenses for at least 7 days and be re-examined to determine that the corneal curvature has returned to its baseline measure. The second design shall be dispensed and scheduled follow-up examinations shall be conducted at one day, one week, and two weeks after dispensing lenses. Each subject shall then cease wearing lenses for at least 7 days and be re-examined to determine that the corneal curvature has returned to its baseline measure.

Conditions

• Myopia

Interventions

Type	Name	Description
OTHER	Corneal Refractive Therapy-spherical	A comparison of two different designs of Corneal Refractive Therapy contact lenses will be done. Each will be worn for two weeks. The sponsor will mask which lens will be first or second in the trial.
OTHER	Corneal Refractive Therapy-aspherical	A comparison of two different designs of Corneal Refractive Therapy contact lenses will be done. Each will be worn for two weeks. The sponsor will mask which lens will be first or second in the trial.

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-10-27
• Completion: 2016-10-27
• First posted: 2022-06-30
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States