| Trial name or title |
"Study of ACCS Eye Drops in Treating Dry Eye" |
| Methods |
Study design: randomized, parallel‐group, controlled trial
Number randomized: 30 (estimated) |
| Participants |
Country: United States
Age: not reported
Gender: both
Inclusion criteria:
"Subjects ages 18 years and older. Subjects with symptoms and signs of Dry Eye for > four months supported by previous clinical diagnosis or self‐reported history. Visual acuity corrected 20/40 or better in each eye.If wearing contact lenses, subjects must be willing to refrain from wearing the contact lenses during the study (including washout period). Score of 25‐75 on the Ocular Surface Disorder Index (OSDI) questionnaire. Corneal staining of grade 2 or more anywhere on the cornea (scale 0‐4)."
Exclusion criteria:
"Pregnant or breast feeding. Anterior segment disease other than Dry Eye which in the opinion of the investigator would confound the study. Macular and neovascular eye diseasesHistory of corneal surgery or LASIK (laser in situ keratomileusis) surgery in either eye within the past year. Use of cyclosporine, steroid eye drops, serum eye drops, or any other eye medication (except for artificial tears) or experimental drug within the past 30 days. Subjects with glaucoma or in whom glaucoma is suspected. Use of anticholinergic drugs, antihistamines, beta‐blockers, or tricyclic anti‐depressants within the past 30 days. Asymmetric punctal plugs or punctal cauterization within the past three months. History of Stevens‐Johnson disease, ocular cicatricial pemphigoid, alkali burn of the eye, or graft‐versus‐host disease. Immune compromise for any reason.Kidney or liver function studies >2x the upper limit of normal. Symptomatic abnormalities od the lid. History of cancer within the past 5 years"
|
| Interventions |
Intervention #1: ACCS 4 times daily
Intervention #2: Refresh Lubricant Eye Drops 4 times daily
Length of follow‐up: 6 weeks |
| Outcomes |
Primary outcome(s): corneal staining with fluorescein
Secondary outcome(s): lissamine staining; endothelial cell count; intraocular pressure; tear volume; assessment of structure and function of the eye; OSDI score
Adverse events: none reported |
| Starting date |
March 2015 |
| Contact information |
Study sponsor: David L Steed, MD (Stemnion, Inc.); US Navy Bureau of Medicine
Investigator: Kathy Kelley, OD (Price Vision Group) |
| Notes |
Status: recruiting |
