N/A N=16 Randomized Double-blind Treatment

Tear Film Break-up Time After Instillation of Artificial Tears

Keratoconjunctivitis Sicca

Bottom Line

View on ClinicalTrials.gov: NCT00681265 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2012

Primary outcome: Primary: Noninvasive Tear Film Break-up Time — 14.67; 7.4 seconds

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: glycerin (Drug); polyethylene glycol 400/propylene glycol (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Calm Water Therapeutics LLC
Primary completion: Aug 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Noninvasive Tear Film Break-up Time	14.67; 7.4	—
SECONDARY Fluorescein Tear Film Break-up Time	11.13; 6.21	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00681265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.