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Scleral Contact Lens Insertion Solution Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03612284
Recruitment Status : Completed
First Posted : August 2, 2018
Last Update Posted : January 18, 2019
Contamac Ltd
Information provided by (Responsible Party):
Jennifer Fogt, Ohio State University

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.

Condition or disease Intervention/treatment Phase
Irregular; Contour of Cornea Device: contact lens insertion solution Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Scleral Contact Lens Insertion Solution Study
Actual Study Start Date : November 27, 2017
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: Device Feasibility

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
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.

Primary Outcome Measures :
  1. Change in corneal staining or corneal disruption as assessed with clinical biomicroscope [ Time Frame: immediately after first use of solution and again in 5 to 9 days ]
    ocular safety examination

  2. Comfort and vision quality as assessed by Ocular Surface Disease Index (OSDI) questionnaire [ Time Frame: 5 to 9 days ]
    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

  3. Comfort as assessed by Current Symptoms Survey (CSS) [ Time Frame: 5 to 9 days ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03612284

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United States, Ohio
The Ohio State University College of Optometry
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Jennifer Fogt
Contamac Ltd
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Principal Investigator: Jennifer Fogt, OD Ohio State University

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Responsible Party: Jennifer Fogt, Associate Professor, Practice, Ohio State University Identifier: NCT03612284     History of Changes
Other Study ID Numbers: 2017H0141
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jennifer Fogt, Ohio State University:
Contact lens solution
Additional relevant MeSH terms:
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Contact Lens Solutions
Pharmaceutical Solutions
Anti-Infective Agents