The Efficacy of an Ocular Emulsion in Meibomian Gland Dysfunction

Sponsor
Southern California College of Optometry at Marshall B. Ketchum University (Other)
Overall Status
Completed
CT.gov ID
NCT01207752
Collaborator
Alcon Research (Industry)
69
Enrollment
1
Location
2
Arms
10
Duration (Months)
6.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study will be to determine the efficacy of this novel, lipid-containing artificial tear on the signs and symptoms of meibomian gland disease.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Systane Balance
  • Drug: Optive Lubricant Eye Drops
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
69 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Efficacy of an Ocular Emulsion on the Signs and Symptoms of Meibomian Gland Dysfunction
Study Start Date :
Sep 1, 2010
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Jul 1, 2011

Arms and Interventions

ArmIntervention/Treatment
Experimental: Systane Balance

Artificial tear emulsion

Drug: Systane Balance
Artificial tear emulsion drop

Active Comparator: Optive Lubricant Eye Drops

Artificial tear

Drug: Optive Lubricant Eye Drops
Artificial tear eye drop

Outcome Measures

Primary Outcome Measures

  1. Tear Film Breakup Time [Measured 2 hours after in-office administration of a single drop of test solution]

    time in seconds to observer a dark spot in the tear film

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Schein symptom score (all 6 questions) of greater than 5,

  • evidence of MGD changes in both eyes (i.e.,

  • lower eyelid secretion quality score greater than 1.0 (0 - 3 scale) OR gland dropout score greater than 1.0 (i.e., greater than 25% of entire lower eyelid) as demonstrated by meiboscopy, and corneal staining of grade 4.0 or greater (0 - 20 scale).

Exclusion Criteria:
  • contact lens wear, use of topical ocular medication other than artificial tears (use of Restasis is specifically excluded),

  • unstable systemic medication use (i.e., anti-histamines, steroids, etc.), recent (within 6 months of study start) ocular trauma or surgery,

  • diabetes, aqueous deficient dry eye (defined as a Schirmer I value (without anesthetic) of < 5 mm of wetting in 5 minutes in either eye), and use of punctal plugs.

-Subjects taking omega 3 fatty acid supplements for dry eye can be included so long as their intake is stable for the prior six months and they meet the inclusion criteria above.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Eye Care CenterFullertonCaliforniaUnited States92831

Sponsors and Collaborators

  • Southern California College of Optometry at Marshall B. Ketchum University
  • Alcon Research

Investigators

  • Principal Investigator: Jerry R Paugh, OD, PhD, Southern California College of Optometry at Marshall B. Ketchum University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jerry R. Paugh, OD, PhD, Professor, Associate Dean for Research, Southern California College of Optometry at Marshall B. Ketchum University
ClinicalTrials.gov Identifier:
NCT01207752
Other Study ID Numbers:
  • SCCO 10-6
First Posted:
Sep 23, 2010
Last Update Posted:
Apr 9, 2021
Last Verified:
Mar 1, 2021
Keywords provided by Jerry R. Paugh, OD, PhD, Professor, Associate Dean for Research, Southern California College of Optometry at Marshall B. Ketchum University
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleSystane BalanceOptive Lubricant Eye Drops
Arm/Group DescriptionArtificial tear emulsion Systane Balance: Artificial tear emulsion dropArtificial tear Optive Lubricant Eye Drops: Artificial tear eye drop
Period Title: Overall Study
STARTED3534
COMPLETED3327
NOT COMPLETED27

Baseline Characteristics

Arm/Group TitleSystane BalanceOptive Lubricant Eye DropsTotal
Arm/Group DescriptionArtificial tear emulsion Systane Balance: Artificial tear emulsion dropArtificial tear Optive Lubricant Eye Drops: Artificial tear eye dropTotal of all reporting groups
Overall Participants353469
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
35
100%
34
100%
69
100%
>=65 years
0
0%
0
0%
0
0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
50.7
(17.7)
54.7
(17.5)
52.7
(2.8)
Sex: Female, Male (Count of Participants)
Female
30
85.7%
24
70.6%
54
78.3%
Male
5
14.3%
10
29.4%
15
21.7%
Region of Enrollment (participants) [Number]
United States
35
100%
34
100%
69
100%

Outcome Measures

1. Primary Outcome
TitleTear Film Breakup Time
Descriptiontime in seconds to observer a dark spot in the tear film
Time FrameMeasured 2 hours after in-office administration of a single drop of test solution

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleSystane BalanceOptive Lubricant Eye Drops
Arm/Group DescriptionArtificial tear emulsion Systane Balance: Artificial tear emulsion dropArtificial tear Optive Lubricant Eye Drops: Artificial tear eye drop
Measure Participants3228
Mean (Standard Deviation) [seconds]
4.65
(1.73)
4.42
(1.14)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Systane Balance, Optive Lubricant Eye Drops
Comments
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesisp-Value0.550
Comments
Methodt-test, 2 sided
Comments

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group TitleSystane BalanceOptive Lubricant Eye Drops
Arm/Group DescriptionArtificial tear emulsion Systane Balance: Artificial tear emulsion dropArtificial tear Optive Lubricant Eye Drops: Artificial tear eye drop
All Cause Mortality
Systane BalanceOptive Lubricant Eye Drops
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total/ (NaN) / (NaN)
Serious Adverse Events
Systane BalanceOptive Lubricant Eye Drops
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/35 (0%) 0/34 (0%)
Other (Not Including Serious) Adverse Events
Systane BalanceOptive Lubricant Eye Drops
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/35 (0%) 0/34 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Results Point of Contact

Name/TitleJerry Paugh, OD, PhD
OrganizationSouthern California College of Optometry at MBKU
Phone714-449-7487
Emailjpaugh@ketchum.edu
Responsible Party:
Jerry R. Paugh, OD, PhD, Professor, Associate Dean for Research, Southern California College of Optometry at Marshall B. Ketchum University
ClinicalTrials.gov Identifier:
NCT01207752
Other Study ID Numbers:
  • SCCO 10-6
First Posted:
Sep 23, 2010
Last Update Posted:
Apr 9, 2021
Last Verified:
Mar 1, 2021