Scleral Contact Lens Insertion Solution Study

NCT03612284 | Completed

• 1 other identifier: 2017H0141
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

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 solution DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.
• Needs to remove scleral lens due to fogging and refill or definitely reports fogging.
• Must have worn habitual scleral lens for at least 3 months
• Willing and able to attend study visits.

You may not qualify if:

• Currently under treatment for an eye infection or inflammation such as adapted keratoconus or healed post penetrating keratoplasty. Stable keratoconus is acceptable.
• Currently taking topical ophthalmic prescription medications.
• Current medical eye complications such as glaucoma or uveitis.
• Recent corneal surgery
• Sjogrens or other clinically significant active ocular surface disease.

Sponsors & Collaborators

• Jennifer Fogt: lead
• Contamac Ltd: collaborator

Study Sites (1)

The Ohio State University College of Optometry

Columbus, Ohio, 43210, United States

Location

Study Officials

• Jennifer Fogt, OD

  Ohio State University

  PRINCIPAL INVESTIGATOR

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
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: January 18, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)