Clinical trial NCT03612284: Scleral Contact Lens Insertion Solution Study
Official title: Scleral Contact Lens Insertion Solution Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irregular; Contour of Cornea
Keywords: Contact lens solution
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Contamac Ltd
First posted: 2018-08-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in corneal staining or corneal disruption as assessed with clinical biomicroscope
timeFrame: immediately after first use of solution and again in 5 to 9 days
measure: Comfort and vision quality as assessed by Ocular Surface Disease Index (OSDI) questionnaire
timeFrame: 5 to 9 days
measure: Comfort as assessed by Current Symptoms Survey (CSS)
timeFrame: 5 to 9 days
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University College of Optometry
state: Ohio
Study officials:
affiliation: Ohio State University
name: Jennifer Fogt, OD
role: PRINCIPAL_INVESTIGATOR
References: