Evaluation of the Ocular Safety of Calcium Formate in Normal, Healthy Female Subjects

Study Overview
=================
Brief Summary
-----------------
This is a Phase I, single center, open-label study of the dietary supplement calcium formate in normal, healthy female subjects. The purpose of the study is to determine whether daily use of calcium formate is safe and whether it accumulates in the eye.

Detailed Description
-----------------
This is a Phase I, single center, open-label study of the dietary supplement calcium formate in normal, healthy female subjects. The purpose of the study is to determine whether daily use of calcium formate is safe and whether it accumulates in the eye.

Official Title
-----------------
Evaluation of the Ocular Safety of Calcium Formate in Normal, Healthy Female Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: calcium formate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy females Exclusion Criteria: no ocular diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open label<br>Each participant will be treated with three 3900 mg doses of calcium formate on each study day (i.e., days 1-14). | Drug: calcium formate<br>* Calcium formate - Each uncoated white tablet will contain 650 mg of calcium formate, (equivalent to 200 mg elemental calcium). Nephro-Tech, LLC, will formulate and provide the calcium formate tablets for the study.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vision Testing (refraction) over baseline | Participants will be refracted at baseline and the resultant lens correction will be used for testing visual acuity at all subsequent visits. If a participant's visual acuity drops 10 letters or more at any visit, the participant will be re-refracted and the visual acuity will be tested again with the new lens correction in place. | Up to 15 days | 
| Change in Serum Formate Levels over baseline | To test for accumulation of formate, morning blood samples for determination of formate will be obtained at screening, prior to administration of the first dose of calcium formate on Study Days 1, 2, 3, and 8 and on day 15. Blood samples for determination of formate will also be obtained approximately 40-60 minutes after ingestion of the second dose on Study Days 1, 2 and 3. | Up to 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Acuity over baseline | Based on retroilluminated Chart R from Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) distance visual acuity chart set. | Up to 15 days | 
| Change in 100 Hue Vision Testing results over baseline | The FM-100 Hue test will be utilized to assess color vision at baseline and at the conclusion of the study. This test requires the arrangement of 100 discs of varying hues in an orderly sequence. The test requires 15 minutes to complete and is noninvasive. The test is scored by a computer. | Up to 15 days | 
| Change in ERG/VEP over baseline | Change in electroretinography (ERG) and visual-evoked potential will be monitored over baseline. | Up to 15 days | 
| Change in Visual Fields over baseline | Automated standardized Humphrey 24-2 visual fields will be performed using the SITA (Swedish Interactive Threshold Algorithm) protocol. This test is standard of care for the assessment and follow-up of optic nerve disorders such as glaucoma or optic neuropathy. It will be performed in the customary manner for evaluation of mean defect. | Up to 15 days | 
| Fundus Photography | Stereoscopic color fundus photographs of both eyes will be taken with a 30 degree fundus camera at baseline, at day 2 and day 8 of study tablet administration 40-60 minutes after the second dose, and at study completion (day 15), early termination, or if a vision drop or AE occurs. These will be compared individually for changes including macular edema, retinal or optic nerve abnormalities or other abnormalities occurring from baseline. | Up to 15 days |