Scleral Contact Lens Insertion Solution Study

Irregular; Contour of Cornea Clinical Trial

Official title: Scleral Contact Lens Insertion Solution Study

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the clinical ocular compatibility (feasibility of safety and efficacy) of a patented solution (US Patent 2,259,437, Stone) which contains multiple essential ions and has a pH and tonicity which more closely mimics human tears as compared to the subjects' current habitual scleral lens insertion solution.

Clinical Trial Description

The sterile solution is provided by prescription for each patient by a local compounding pharmacy in unit dose containers. The initial exposure - filling the posterior bowl of the scleral contact lens by the Investigator and applying the lens to the eye - will be monitored in the office for one hour, prior to any dispensing of the solution to the patient for their use at home or work.

This is a one week, unmasked comparison of the new solution to the subject's habitual solution used for scleral lens insertion. The (historical) control is the saline habitually used by the subjects.

The sample size is determined to be manageable to insure close supervision of the subjects in these initial trials and to inform us for future safety and efficacy trials.

The primary safety outcome measure will be slit lamp examination of the ocular anterior segment and the secondary outcome measure will be photo-documentation by ocular coherence tomography of the clouding of the tears between the cornea and scleral contact lens. The primary efficacy outcome will be ocular comfort as assessed by questionnaire. ;

Related Conditions & MeSH terms

• Irregular; Contour of Cornea

• NCT number: NCT03612284
• Study type: Interventional
• Source: Ohio State University
• Status: Completed
• Phase: N/A
• Start date: November 27, 2017
• Completion date: November 30, 2018