A Randomized, Masked Exploratory Trial Comparing the Effect of Two Different Over-the-Counter Artificial Tear Preparations on Tear Film Break-up Time
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Calm Water Therapeutics LLC
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Noninvasive Tear Film Break-up Time
Study Overview
Brief Summary
This study is an exploratory trial evaluating the tear film break-up time after a single eye drop instillation of over-the-counter artificial tears. The primary hypothesis is that tear film break up time will be greater for test than control eye.
Detailed Description
Subjects with varying degrees of dry eye syndrome were enrolled in a randomized, controlled, double masked, single site study. A new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient was compared against a leading commercial product with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent. The primary outcome was a comparison of tear film stability after eye drop instillation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age > 18 years
- •symptoms of dry eye
- •no other history of ophthalmic problems
Exclusion Criteria
- •Use of any ocular lubricant or ointment in the past 36 hours
- •use of contact lenses or excessive eye lid cosmetics on the study day
Arms & Interventions
glycerin
One eye will randomly receive a single instillation of one drop of a new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient.
Intervention: glycerin (Drug)
polyethylene glycol 400/propylene glycol
The other eye will receive a single instillation of one drop of an artificial tear with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent.
Intervention: polyethylene glycol 400/propylene glycol (Drug)
Outcomes
Primary Outcomes
Noninvasive Tear Film Break-up Time
Time Frame: 15 minutes after eye drop instillation
State-of-the-art methodology to assess tear stability.
Secondary Outcomes
- Fluorescein Tear Film Break-up Time(120 minutes after eye drops instillation)