ESBA105 in Patients With Severe Dry Eye

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01338610
• Collaborator: (none)
• Enrollment: 334
• Location: 1
• Arms: 2
• Duration (Months): 8
• Patients Per Site Per Month: 41.5

Study Details

Study Description

Brief Summary

The purpose of this study was to evaluate the efficacy of ESBA105 over vehicle in reducing the ocular symptoms of dry eye disease, as measured by a mean global Visual Analog Scale (VAS) discomfort score.

Condition or Disease	Intervention/Treatment	Phase
Eyes Dry Chronic	Biological: ESBA105 ophthalmic solution; Other: ESBA105 vehicle	Phase 2

Detailed Description

Following Run-In, patients qualifying for treatment were randomized 2:1 to receive ESBA105 (experimental group) or Vehicle (control group) for 4 weeks. Patients not qualifying for treatment (based on global VAS discomfort score), were discontinued from the study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 334 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Evaluation of ESBA105 in the Persistent Relief of Ocular Discomfort in Patients With Severe Dry Eye
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ESBA105 ESBA105 ophthalmic solution, 1 drop in each eye 3 times per day for 4 weeks	Biological: ESBA105 ophthalmic solution
Placebo Comparator: Vehicle ESBA105 vehicle, 1 drop in each eye 3 times per day for 4 weeks	Other: ESBA105 vehicle; Inactive ingredients used as Run-In and placebo comparator

Outcome Measures

Primary Outcome Measures

1. Visual Analog Scale (VAS) Global Ocular Discomfort Score, Area Under the Curve, Day 0 to Day 28 [Up to 28 days]

   An electronic Visual Analog Scale (eVAS) was used by the subject to assess ocular discomfort, both frequency and severity, at Day 0 (pre-treatment) and daily thereafter for 28 days. Assessments were entered into a LogPad® (handheld electronic device). The VAS frequency score ranged from 0 (rarely) to 100 (all the time), and the VAS severity score ranged from 0 (very mildly uncomfortable) to 100 (very severely uncomfortable). The Global Ocular Discomfort Score is a composite of the frequency and severity VAS scores (0-100).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Ongoing physician diagnosis of dry eye for at least 6 months.

• Use of artificial tears, gels, lubricants, or re-wetting drops on a regular basis.

• Experience persistent ocular discomfort.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Contact lens wearers.

• Severe Sjogren's Syndrome.

• History of corneal surgery including refractive surgeries.

• Intraocular surgery within 6 months of Visit 1.

• Intraocular or periocular injection within 6 months of Visit 1.

• Lid function abnormalities.

• Use of steroids, tetracycline, doxycycline, etc., within 30 days of Visit 1.

• Any acute infectious or non-infectious ocular condition of the anterior or posterior segments in either eye within 30 days of Visit 1.

• Diseases/conditions of ocular surface associated with clinically significant scarring/destruction of conjunctiva/cornea.

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas	United States	76134

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01338610
• Other Study ID Numbers: C-10-079
• First Posted: Apr 19, 2011
• Last Update Posted: Apr 19, 2013
• Last Verified: Apr 1, 2013

• Keywords provided by Alcon Research: Ocular discomfort
• Additional relevant MeSH terms: Dry Eye Syndromes; Ophthalmic Solutions

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 16 investigative sites located within the United States. Participant flow data is presented for all subjects exposed to product.
Pre-assignment Detail	Of the 334 enrolled, 210 subjects did not qualify for Run-In and were exited from the study without exposure to product. Of the 124 entering Run-In, 39 did not qualify for treatment. The 85 subjects qualifying for treatment were randomized 2:1 to receive either ESBA105 or Vehicle.

Arm/Group Title	Run-In Only	ESBA105	Vehicle
Arm/Group Description	ESBA105 vehicle	ESBA105 vehicle (Run-In), ESBA105 ophthalmic solution (treatment)	ESBA105 vehicle (Run-In), ESBA105 vehicle (treatment)
Period Title: Overall Study
STARTED	39	56	29
COMPLETED	34	55	28
NOT COMPLETED	5	1	1

Baseline Characteristics

Arm/Group Title	Run-In Only	ESBA105	Vehicle	Total
Arm/Group Description	ESBA105 vehicle	ESBA 105 vehicle (Run-In), ESBA105 ophthalmic solution (treatment)	ESBA105 vehicle (Run-In), ESBA105 vehicle (treatment)	Total of all reporting groups
Overall Participants	39	56	29	124
Age, Customized (participants) [Number]
<65	24 61.5%	32 57.1%	21 72.4%	77 62.1%
≥65	15 38.5%	24 42.9%	8 27.6%	47 37.9%
Sex: Female, Male (Count of Participants)
Female	35 89.7%	45 80.4%	26 89.7%	106 85.5%
Male	4 10.3%	11 19.6%	3 10.3%	18 14.5%
Region of Enrollment (participants) [Number]
United States	39 100%	56 100%	29 100%	124 100%

Outcome Measures

1. Primary Outcome

Title	Visual Analog Scale (VAS) Global Ocular Discomfort Score, Area Under the Curve, Day 0 to Day 28
Description	An electronic Visual Analog Scale (eVAS) was used by the subject to assess ocular discomfort, both frequency and severity, at Day 0 (pre-treatment) and daily thereafter for 28 days. Assessments were entered into a LogPad® (handheld electronic device). The VAS frequency score ranged from 0 (rarely) to 100 (all the time), and the VAS severity score ranged from 0 (very mildly uncomfortable) to 100 (very severely uncomfortable). The Global Ocular Discomfort Score is a composite of the frequency and severity VAS scores (0-100).
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

All subjects randomized to treatment and receiving at least 1 administration of study medication (intent-to-treat). Mixed model repeated measure (MMRM) approach was used to handle missing data during randomized treatment period.

Arm/Group Title	ESBA105	Vehicle
Arm/Group Description	ESBA105 ophthalmic solution	ESBA105 vehicle
Measure Participants	56	29
Least Squares Mean (Standard Error) [Units on a scale x days]	63.8773 (2.4832)	70.2194 (2.39802)

Adverse Events

Time Frame	Adverse events were collected for the duration of the study.
Adverse Event Reporting Description	The safety population includes all subjects exposed to product. Individual subject adverse events, solicited and unsolicited, were collected from time of first instillation of test article (Run-In) until the subject exited the study.
Arm/Group Title	Run-In		ESBA105		Vehicle
Arm/Group Description	ESBA105 vehicle, all participants		ESBA105 ophthalmic solution		ESBA105 vehicle
All Cause Mortality
	Run-In		ESBA105		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Run-In		ESBA105		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/124 (0%)		0/56 (0%)		0/29 (0%)
Other (Not Including Serious) Adverse Events
	Run-In		ESBA105		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/124 (0%)		0/56 (0%)		0/29 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.