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)
• Enrollment: 69
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 6.9

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 Disease	Intervention/Treatment	Phase
Meibomian Gland Dysfunction	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

Arm	Intervention/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

	Site	City	State	Country	Postal Code
1	Eye Care Center	Fullerton	California	United States	92831

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: dry eye, meibomian gland dysfunction, tear film break up time
• Additional relevant MeSH terms: Meibomian Gland Dysfunction; Ophthalmic Solutions; Lubricant Eye Drops

Study Results

Participant Flow

Arm/Group Title	Systane Balance	Optive Lubricant Eye Drops
Arm/Group Description	Artificial tear emulsion Systane Balance: Artificial tear emulsion drop	Artificial tear Optive Lubricant Eye Drops: Artificial tear eye drop
Period Title: Overall Study
STARTED	35	34
COMPLETED	33	27
NOT COMPLETED	2	7

Baseline Characteristics

Arm/Group Title	Systane Balance	Optive Lubricant Eye Drops	Total
Arm/Group Description	Artificial tear emulsion Systane Balance: Artificial tear emulsion drop	Artificial tear Optive Lubricant Eye Drops: Artificial tear eye drop	Total of all reporting groups
Overall Participants	35	34	69
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

Title	Tear Film Breakup Time
Description	time in seconds to observer a dark spot in the tear film
Time Frame	Measured 2 hours after in-office administration of a single drop of test solution

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Systane Balance	Optive Lubricant Eye Drops
Arm/Group Description	Artificial tear emulsion Systane Balance: Artificial tear emulsion drop	Artificial tear Optive Lubricant Eye Drops: Artificial tear eye drop
Measure Participants	32	28
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 Hypothesis	p-Value	0.550
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Arm/Group Title	Systane Balance		Optive Lubricant Eye Drops
Arm/Group Description	Artificial tear emulsion Systane Balance: Artificial tear emulsion drop		Artificial tear Optive Lubricant Eye Drops: Artificial tear eye drop
All Cause Mortality
	Systane Balance		Optive Lubricant Eye Drops
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Systane Balance		Optive Lubricant Eye Drops
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/34 (0%)
Other (Not Including Serious) Adverse Events
	Systane Balance		Optive Lubricant Eye Drops
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/34 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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