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Clinical Trial Results:
A Multicenter, Double-masked, Randomized Study to Compare the Safety and Efficacy of an Investigational Eye Drop Formulation with OPTIVE™ Unit-Dose for 3 Months in Subjects with Dry Eye Disease

Summary
EudraCT number	2012-002238-35
Trial protocol	GB BE DE IT ES
Global end of trial date	23 May 2014

Results information
Results version number	v1(current)
This version publication date	30 Mar 2016
First version publication date	30 Mar 2016
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

11002X-001

ISRCTN number

-

US NCT number

NCT01664949

WHO universal trial number (UTN)

-

Sponsor organisation name

Allergan Limited

Sponsor organisation address

Allergan Limited Marlow International The Parkway, Marlow, United Kingdom,

Public contact

Allergan Limited EU Regulatory Dept, Allergan Limited, +44 1628 494444, ml-eu_reg_affairs@allergan.com

Scientific contact

Allergan Limited EU Regulatory Dept, Allergan Limited, +44 1628 494444, ml-eu_reg_affairs@allergan.com

Is trial part of an agreed paediatric investigation plan (PIP)

No

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Analysis stage

Final

Date of interim/final analysis

08 Oct 2014

Is this the analysis of the primary completion data?

Yes

Primary completion date

23 May 2014

Global end of trial reached?

Yes

Global end of trial date

23 May 2014

Was the trial ended prematurely?

No

Main objective of the trial

This study evaluated the safety and efficacy of a carboxymethylcellulose based eye drop formulation compared with carboxymethylcellulose based preservative-free lubricant eye drops [OPTIVE Unit-dose (UD)] in subjects with dry eye disease.

Protection of trial subjects

All participants were required to read and sign an informed consent form.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

04 Feb 2013

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

No

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 112

Country: Number of subjects enrolled

Belgium: 27

Country: Number of subjects enrolled

France: 40

Country: Number of subjects enrolled

Germany: 86

Country: Number of subjects enrolled

Italy: 53

Country: Number of subjects enrolled

Russian Federation: 30

Country: Number of subjects enrolled

Spain: 82

Country: Number of subjects enrolled

United Kingdom: 30

Worldwide total number of subjects

460

EEA total number of subjects

318

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

297

From 65 to 84 years

159

85 years and over

4

Subject disposition

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Recruitment details

-

Screening details

Participants with signs and symptoms of dry eye disease were enrolled in one of 2 treatment groups: Carboxymethylcellulose Based Eye Drop Formulation A or OPTIVE Unit-dose (UD).

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Investigator, Monitor, Carer, Data analyst, Subject

Are arms mutually exclusive

Yes

Carboxymethylcellulose Based Eye Drop Formulation A

Arm description

Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.

Arm type

Experimental

Investigational medicinal product name

Carboxymethylcellulose Based Eye Drop Formulation A

Investigational medicinal product code

Other name

Pharmaceutical forms

Eye drops, solution in single-dose container

Routes of administration

Ocular use

Dosage and administration details

1 to 2 drops in each eye as needed, at least twice daily

OPTIVE UD

Arm description

Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE UD) 1-2 drops in each eye as needed at least 2 times daily for 90 days.

Arm type

Active comparator

Investigational medicinal product name

OPTIVE UD

Investigational medicinal product code

Other name

OPTAVA™, OPTIVE™

Pharmaceutical forms

Eye drops, solution in single-dose container

Routes of administration

Ocular use

Dosage and administration details

1 to 2 drops in each eye as needed, at least twice daily

Number of subjects in period 1	Carboxymethylcellulose Based Eye Drop Formulation A	OPTIVE UD
Started	224	236
Completed	200	211
Not completed	24	25
Adverse event, non-fatal	11	12
Personal Reasons	3	4
Lost to follow-up	1	2
Other Miscellaneous Reasons	3	1
Lack of efficacy	1	1
Protocol deviation	5	5

Baseline characteristics

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Reporting group title

Carboxymethylcellulose Based Eye Drop Formulation A

Reporting group description

Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.

Reporting group title

OPTIVE UD

Reporting group description

Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE UD) 1-2 drops in each eye as needed at least 2 times daily for 90 days.

Reporting group values	Carboxymethylcellulose Based Eye Drop Formulation A	OPTIVE UD	Total
Number of subjects	224	236	460
Age categorical
Units: Subjects
< 30 years	9	10	19
30 to 40 years	15	15	30
> 40 years	200	211	411
Age continuous
Units: years
arithmetic mean (standard deviation)	59.6 ( 13.77 )	57.6 ( 13.65 )	-
Gender, Male/Female
Units: Participants
Female	182	189	371
Male	42	47	89

End points

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Reporting group title

Carboxymethylcellulose Based Eye Drop Formulation A

Reporting group description

Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.

Reporting group title

OPTIVE UD

Reporting group description

Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE UD) 1-2 drops in each eye as needed at least 2 times daily for 90 days.

Primary: Change from Baseline in Ocular Surface Disease Index (OSDI) Score at Day 90

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End point title

Change from Baseline in Ocular Surface Disease Index (OSDI) Score at Day 90 ^[1]

End point description

The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst). A negative number change from Baseline indicates improvement.

End point type

Primary

End point timeframe

Baseline, Day 90

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No Statistical Analysis is reported for this outcome measure

End point values	Carboxymethylcellulose Based Eye Drop Formulation A	OPTIVE UD
Number of subjects analysed	196	198
Units: score on a scale
arithmetic mean (standard deviation)
Baseline (n=196,198)	41.77 ( 14.018 )	40.92 ( 13.31 )
Change from Baseline at Day 90 (n=181,185)	-16.88 ( 17.496 )	-15.97 ( 16.146 )

No statistical analyses for this end point

Secondary: Change from Baseline in Tear Break-up Time (TBUT)

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End point title

Change from Baseline in Tear Break-up Time (TBUT)

End point description

TBUT is the time in seconds for the tear film to visually break up after a complete blink. The average of 3 consecutive observations is reported for each participant. The longer it takes, the more stable the tear film. The eye with the shorter average TBUT at Baseline was used for analysis. A positive number change from Baseline indicates improvement.

End point type

Secondary

End point timeframe

Baseline, Day 90

End point values	Carboxymethylcellulose Based Eye Drop Formulation A	OPTIVE UD
Number of subjects analysed	196	198
Units: seconds
arithmetic mean (standard deviation)
Baseline (n=196,198)	4.5 ( 1.868 )	4.44 ( 1.894 )
Change from Baseline at Day 90 (n=181,185)	2.69 ( 5.167 )	2.24 ( 3.262 )

No statistical analyses for this end point

Secondary: Change from Baseline in Corneal Staining

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End point title

Change from Baseline in Corneal Staining

End point description

Staining of the cornea following ocular administration of fluorescein dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The eye with the higher score at Baseline was used for analysis. The higher the grade score, the worse the dry eye severity. A negative number change from Baseline indicates improvement.

End point type

Secondary

End point timeframe

Baseline, Day 90

End point values	Carboxymethylcellulose Based Eye Drop Formulation A	OPTIVE UD
Number of subjects analysed	196	198
Units: score on a scale
arithmetic mean (standard deviation)
Baseline (n=196,198)	1.5 ( 0.99 )	1.6 ( 0.99 )
Change from Baseline at Day 90 (n= 182, 184)	-0.7 ( 0.88 )	-0.9 ( 0.91 )

No statistical analyses for this end point

Secondary: Change from Baseline in Conjunctival Staining

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End point title

Change from Baseline in Conjunctival Staining

End point description

Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). Conjunctival staining has 2 zones, nasal and temporal, which are added together to provide the total staining score. The eye with the higher score at Baseline was used for analysis. The higher the grade score, the worse the dry eye severity. A negative number change from Baseline indicates improvement.

End point type

Secondary

End point timeframe

Baseline, Day 90

End point values	Carboxymethylcellulose Based Eye Drop Formulation A	OPTIVE UD
Number of subjects analysed	196	198
Units: score on a scale
arithmetic mean (standard deviation)
Baseline (n=196,198)	2.8 ( 1.7 )	3 ( 1.79 )
Change from Baseline at Day 90 (n= 181, 185)	-1.3 ( 1.57 )	-1.4 ( 1.59 )

No statistical analyses for this end point

Secondary: Change from Baseline in the Schirmer Test

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End point title

Change from Baseline in the Schirmer Test

End point description

The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye. The eye with the lower value at Baseline was used for Analysis. Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears. The smaller the number, the more severe the dry eye. A positive number change from Baseline indicates improvement.

End point type

Secondary

End point timeframe

Baseline, Day 90

End point values	Carboxymethylcellulose Based Eye Drop Formulation A	OPTIVE UD
Number of subjects analysed	196	198
Units: mm/5 minutes
arithmetic mean (standard deviation)
Baseline (n=196,198)	9.29 ( 6.692 )	8.1 ( 5.888 )
Change from Baseline at Day 90 (n=172,174)	1.38 ( 6.933 )	1.53 ( 6.253 )

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Up to 90 Days

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

17.0

Reporting group title

OPTIVE UD

Reporting group description

Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE UD) 1-2 drops in each eye as needed at least 2 times daily for 90 days.

Reporting group title

Carboxymethylcellulose Based Eye Drop Formulation A

Reporting group description

Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.

Serious adverse events	OPTIVE UD	Carboxymethylcellulose Based Eye Drop Formulation A
Total subjects affected by serious adverse events
subjects affected / exposed	4 / 236 (1.69%)	5 / 224 (2.23%)
number of deaths (all causes)	0	0
number of deaths resulting from adverse events	0	0
Congenital, familial and genetic disorders
Vitello-intestinal duct remnant
subjects affected / exposed	1 / 236 (0.42%)	0 / 224 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Atrial fibrillation
subjects affected / exposed	0 / 236 (0.00%)	1 / 224 (0.45%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure
subjects affected / exposed	0 / 236 (0.00%)	1 / 224 (0.45%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	0 / 236 (0.00%)	1 / 224 (0.45%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Carotid artery stenosis
subjects affected / exposed	0 / 236 (0.00%)	1 / 224 (0.45%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Immune system disorders
Anti-neutrophil cytoplasmic antibody positive vasculitis
subjects affected / exposed	1 / 236 (0.42%)	0 / 224 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ear and labyrinth disorders
Sudden hearing loss
subjects affected / exposed	1 / 236 (0.42%)	0 / 224 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
Benign prostatic hyperplasia
Additional description: Adverse Event male specific.
subjects affected / exposed	1 / 236 (0.42%)	0 / 224 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Anxiety disorder
subjects affected / exposed	0 / 236 (0.00%)	1 / 224 (0.45%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Glomerulonephritis
subjects affected / exposed	1 / 236 (0.42%)	0 / 224 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	0 / 236 (0.00%)	1 / 224 (0.45%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Pyelonephritis acute
subjects affected / exposed	0 / 236 (0.00%)	1 / 224 (0.45%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	1 / 236 (0.42%)	0 / 224 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	OPTIVE UD	Carboxymethylcellulose Based Eye Drop Formulation A
Total subjects affected by non serious adverse events
subjects affected / exposed	6 / 236 (2.54%)	15 / 224 (6.70%)
Eye disorders
Eye irritation
subjects affected / exposed	6 / 236 (2.54%)	15 / 224 (6.70%)
occurrences all number	7	18

More information

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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