NCT03097614

Dry Eye Symptom Relief Assessment With Use of TrueTear in a Controlled Adverse Environment

Completed NA Results posted Last updated 18 October 2018

What this trial tests

NA trial testing TrueTear in Dry Eye in 57 participants. Completed in 26 June 2017.

Timeline

31 March 2017

Primary endpoint
26 June 2017

26 June 2017

Quick facts

Lead sponsor	Oculeve, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	57
Start date	31 March 2017
Primary completion	26 June 2017
Estimated completion	26 June 2017
Sites	1 location across United States

Drugs / interventions tested

• TrueTear

Conditions studied

• Dry Eye — all drugs for Dry Eye →
• Dry Eye Syndromes — all drugs for Dry Eye Syndromes →

Sponsor

Oculeve, Inc.

Who can join

22 and older, any sex, with Dry Eye or Dry Eye Syndromes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Eye Dryness Score Primary · Day 45

Eye Dryness Score using a visual analog scale assessed in the Controlled Adverse Environment (CAE). The participant rates their current eye dryness (both eyes simultaneously) by scoring 0 to indicate "no discomfort" and 100 to indicate "maximal discomfort". The assessment line length of the scale will be 100 mm.

Group	Value	95% CI
TrueTear	48	± 15.2

Sponsor's own description

This study characterizes acute dry eye symptom control, assessed during exposure to a Controlled Adverse Environment, following use of the TrueTear for 45 days.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.