ClinicalTrials.gg
CompletedNCT02139033Updated Jun 11, 2014

A Phase 4 Study Investigating the Efficacy of Retaine™ in Managing Signs and Symptoms Associated With Dry Eye Syndrome

A Phase 4 interventional study of Retaine™ in Keratoconjunctivitis Sicca, sponsored by Ocusoft, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-11.

Sponsored by Ocusoft, Inc. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
42
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This study will evaluate the efficacy of Retaine™ ophthalmic emulsion in treating the signs and symptoms of dry eye syndrome.

02

Conditions studied

  • Keratoconjunctivitis Sicca

Keywords

  • Dry Eye, Dry Eye Syndrome, Retaine, KCS, Keratoconjunctivitis sicca
03

In context

Keratoconjunctivitis Sicca

797 studies on the registry are indexed under Keratoconjunctivitis Sicca; 56 are open to participants now.

This study's enrollment of 42 is below the median of 73 across 674 interventional studies indexed under Keratoconjunctivitis Sicca.

Browse Keratoconjunctivitis Sicca studies →

Lead sponsor

This is the only study on the registry with Ocusoft, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Be at least 18 years of age;
  • Provide written informed consent;
  • Have a reported history of dry eye;
  • Have a history of use or desire to use eye drops;

Exclusion criteria

Exclusion Criteria:

  • Have any clinically significant eye findings that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
  • Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
  • Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
  • Have used Restasis® within 30 days of Visit 1;
  • Be a woman who is pregnant, nursing or planning a pregnancy;
  • Be unwilling to submit a urine pregnancy test if of childbearing potential;
  • Have a known allergy and/or sensitivity to the test article or its components;
  • Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;
  • Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    Arm 1

    Retain 1-2 drops, bilaterally, BID

    Drug: Retaine™

Interventions

  • DrugRetaine™
06

What researchers measure

Primary outcomes

  1. Tear Film Break-Up Time

    Time frame: Day 15

  2. Ocular surface damage as measured by fluorescein staining

    Time frame: Day 15

07

Study locations

1 site
  • Andover, Massachusetts 01810, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02139033
Lead sponsor
Ocusoft, Inc.
Collaborators
ORA, Inc.
Responsible party
Sponsor
First posted
May 15, 2014
Start date
May 2014
Primary completion
May 2014
Completion
May 2014
Last update
Jun 11, 2014
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion