Trials Sponsors Conditions Drugs Pricing

Conditions

Irregular; Contour of Cornea

Keywords

Contact lens solution

Outcome Measures

Primary Outcomes (3)

Change in corneal staining or corneal disruption as assessed with clinical biomicroscope
ocular safety examination
immediately after first use of solution and again in 5 to 9 days
Comfort and vision quality as assessed by Ocular Surface Disease Index (OSDI) questionnaire
Subjects will answer the OSDI questionnairre (score of 0-48) used to assess symptoms related to comfort and vision. The survey will be done with the subjects regular solution and repeated after using the test solution
5 to 9 days
Comfort as assessed by Current Symptoms Survey (CSS)
Subjects will respond to the CSS survey (scores of 0-100 for various symptoms) - used to assess symptoms related to comfort and vision. The survey will be done with the subjects regular solution and repeated after using the test solution
5 to 9 days

Study Arms (1)

Device Feasibility

EXPERIMENTAL

Scleral lens insertion solution study. This is not an interventional study, but a study to test a new contact lens solution. Primary FDA Classification: 21 CFR 886.5928 Soft (Hydrophilic) Contact Lens Care Products Product Code: LPN Secondary FDA Classification: 21 CFR 886.5918 - Rigid gas permeable contact lens care products Product Code: MRC The FDA has previously made risk determinations (class II, non-significant risk) for devices classified under 21 CFR 886.5928 and 21 CFR 886.5918. As a non-significant risk device, the GatorFil Contact Lens Saline Solution is exempt from the IDE regulation (21 CFR 812).

Device: contact lens insertion solution

Interventions

contact lens insertion solutionDevice

This contact lens solution is being tested for safety and comfort and is not an "intervention." Subjects will have their scleral contact lenses filled with the test saline in the examination room and applied to their eyes. They will be monitored for symptoms and will be examined. Six to 8 hours later or whenever their lens clouding typically occurs they will return for further assessment and dispensing of solution if acceptable. subjects will use the solution for 5-9 days and return for a follow-up appointment. At each visit, subjects will complete an OSDI questionnaire and a Current Symptoms questionnaire.

Device Feasibility

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age 18 years and older.
Wear a scleral contact lens habitually 6 or more hours a day.

Sponsors & Collaborators

Contamac Ltd
Industrycollaborator
Jennifer Fogt
Otherlead

Study Sites (1)

The Ohio State University College of Optometry

Columbus, Ohio, 43210, United States

Study Officials

Jennifer Fogt, OD
Ohio State University
PRINCIPAL INVESTIGATOR

Enrollment

30 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: DEVICE FEASIBILITY
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Associate Professor, Practice

Study Record Dates

First Submitted

June 4, 2018

First Posted

August 2, 2018

Study Start

November 27, 2017

Actual (reported)

Scleral Contact Lens Insertion Solution Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (1)

Device Feasibility

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (1)

Device Feasibility

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations