NCT01077011

Brief Summary

The purpose of this study is to compare the comfort and blurriness of an investigational lubricant eye drop with a marketed lubricant eye gel.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 26, 2010

Completed
Last Updated

November 21, 2016

Status Verified

January 1, 2012

Enrollment Period

Same day

First QC Date

February 18, 2010

Last Update Submit

November 18, 2016

Conditions

Dry Eye

Keywords

Dry eyeartificial tears

Outcome Measures

Primary Outcomes (2)

  • Three-minute visual blur profile

    Through 3 minutes (post-instillation)

  • Overall Acceptability

    Immediately upon instillation

Secondary Outcomes (1)

  • Drop Comfort Upon Instillation

    Immediately upon installation

Study Arms (2)

Lubricant eye drop

EXPERIMENTAL

Lubricant eye drop

Other: Lubricant eye drop FID 115958D

GenTeal Gel

ACTIVE COMPARATOR

GenTeal Gel

Other: GenTeal Gel

Interventions

Lubricant eye drop FID 115958DOTHER

1 drop in each eye, one time

Lubricant eye drop
GenTeal GelOTHER

1 drop in each eye, one time

GenTeal Gel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented diagnosis of dry eye

You may not qualify if:

  • Must not have worn contact lenses within 12 hours preceding enrollment
  • Must not have used any topical ocular drops or ointment within 24 hours preceding enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • http://www.aaopt.org/evaluation-efficacy-and-patient-acceptance-new-lubricant-eye-gel

    RESULT

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2010

First Posted

February 26, 2010

Study Start

January 1, 2010

Primary Completion

January 1, 2010

Last Updated

November 21, 2016

Record last verified: 2012-01