NCT03525704

Evaluation of Contact Lens Saline Solutions With Scleral GP Contact Lens Wearers Experiencing Fogging

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Contamac Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Evaluation of saline solutions used with scleral rigid gas permeable contact lens wearers experiencing debris in the post lens tear reservoir

Detailed description

One-month, approximately 36 subjects enrolled (\~12/site), randomized, double-masked crossover trial. Existing scleral rigid gas permeable (RGP) contact lens wearing subjects are randomly assigned (block) to different arms of the trial and receive different saline solutions for use sequentially for 2-week periods. The subjects will continue to wear their existing scleral GP lenses if lens fit is acceptable following an initial evaluation. Subjects will agree to complete a survey administered daily (via email) that will address contact lens wear time and subjective symptoms.

Conditions

• Contact Lens Complication
• Debris in Post Lens Tear Reservoir

Interventions

Type	Name	Description
DEVICE	Saline Solution Enriched	Sterile single dose, Preservative Free, PH Balanced, Enriched with IONs rinsing and Insertion Solution
DEVICE	Saline Rinse Solution	sterile unit dose non-preserved, 0.9% NaCl (normal saline) solution i

Timeline

• Start date: 2018-04-09
• Primary completion: 2018-12-15
• Completion: 2018-12-15
• First posted: 2018-05-16
• Last updated: 2021-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study