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Trial registered on ANZCTR


Registration number
ACTRN12612000121864
Ethics application status
Approved
Date submitted
16/12/2011
Date registered
25/01/2012
Date last updated
25/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot open label clinical trial on the comparison of three months treatment with arabinogalactan monodose ophthalmic formulation 5% or hyaluronic acid 0.2% (Hyalistil (Registered Trademark) monodose 0.2%) in patients with moderate dry eye syndrome.
Scientific title
In patients with moderate dry eye syndrome is a three months treatment with with arabinogalactan monodose ophthalmic formulation 5% as safe and effective as hyaluronic acid 0.2% for the control of subjective and objective symptoms of dry eye?
Secondary ID [1] 273615 0
None
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate dry eye syndrome 285411 0
Condition category
Condition code
Eye 285592 285592 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arabinogalactan monodose ophthalmic 5% (mass/volume percentage) solution, 4 drops per day, over a total of 2 months.
Intervention code [1] 283900 0
Treatment: Devices
Comparator / control treatment
Hyaluronic acid monodose 0.2% (mass/volume percentage) solution (Hyalistil (Registered Trademark) monodose 2%), 4 drops per day, over a total of 2 months.
Control group
Active

Outcomes
Primary outcome [1] 286158 0
Difference of Ocular Surface Disease Index (OSDI) between treatments
Timepoint [1] 286158 0
Weeks: 0, 14, 28, 42, 56, 84
Secondary outcome [1] 295258 0
Schirmer's I test, for the assessment of the tear production
Timepoint [1] 295258 0
Weeks: 0, 14, 28, 42, 56, 84
Secondary outcome [2] 295259 0
Break Up Time (BUT), for the assessment of the stability of the precorneal tear film
Timepoint [2] 295259 0
Weeks: 0, 14, 28, 42, 56, 84
Secondary outcome [3] 295260 0
Corneal and Conjunctival Staining, for the assessment of the integrity of the ocular surface
Timepoint [3] 295260 0
Weeks: 0, 14, 28, 42, 56, 84
Secondary outcome [4] 295261 0
Tolerability questionnaire
Timepoint [4] 295261 0
Weeks: 14, 28, 42, 56, 84
Secondary outcome [5] 295660 0
Emerging adverse events, assessed by the investigator asking open questions to the patient (e.g. "Did you experience any symptom or medical problem since last visit?").
Timepoint [5] 295660 0
Weeks: 14, 28, 42, 56, 84

Eligibility
Key inclusion criteria
1. Written informed consent.
2. Male and female subjects ages >18 years.
3. Diagnosis of moderate dry-eye syndrome confirmed at least two months prior screening visit.
4. At the screening visit, all the following conditions must be present: a) sum of scores for all answered questions of the OSDI questionnaire between 10 and 25 (mild to moderate); b) BUT < 10 seconds or Schirmer-1 test < 5.5 mm after 5 minutes; c) at least one ocular surface area having score > 2 (corneal or conjunctival damage grading from 0 to 3) when intravital stained.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Difficulty in understanding properly the questionnaire on dry eye.
2. Pregnant or breastfeeding women.
3. Eye surgery performed in the previous three months.
4. Treatment in the previous three months of dry eye with any ophthalmic formulation of hyaluronic acid.
5. Use of any other eye drop treatment, other than specified study product, for duration of study.
6. Contact lenses wearers.
7. Severe dry-eye sufferers defined as patients with a BUT <1.5 seconds.
8. Presence or onset of eye infections or of other acute pathologies that might resolve or evolve throughout the study regardless of the study treatment.
9. Onset during the study of eye pathologies capable of causing alterations of tear secretion and in the ocular surface.
10. Participation in a clinical trial within 3 months of the beginning of the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The egegibility was assessed by the investigator. The allocation of patients to numbered containers occurred in sequential order of presentation. The patient was kept blinded to the treatment received, but the containers of the two treatments were physically different.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomization list (SAS function)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4023 0
Italy
State/province [1] 4023 0

Funding & Sponsors
Funding source category [1] 284392 0
Commercial sector/Industry
Name [1] 284392 0
Opocrin SpA
Address [1] 284392 0
Via Pacinotti, 3
41040 Corlo di Formigine
MODENA
Country [1] 284392 0
Italy
Primary sponsor type
Commercial sector/Industry
Name
Opocrin SpA
Address
Via Pacinotti, 3
41040 Corlo di Formigine
MODENA
Country
Italy
Secondary sponsor category [1] 283321 0
None
Name [1] 283321 0
Address [1] 283321 0
Country [1] 283321 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286350 0
Comitato Etico dell`Azienda Ospedaliera Universitaria San Martino di Genova
Ethics committee address [1] 286350 0
Largo Rosanna Benzi 10
16132 GENOVA
Ethics committee country [1] 286350 0
Italy
Date submitted for ethics approval [1] 286350 0
06/07/2009
Approval date [1] 286350 0
27/10/2009
Ethics approval number [1] 286350 0
Nil

Summary
Brief summary
Controlled open label randomized monocenter clinical study designed to evaluate, in patients suffering from moderate dry eye syndrome, subjective and objective safety and efficacy parameters during and after three months of treatment (4 drops per day) with arabinogalactan 5% w/v solution or hyaluronic acid 0.2% w/v solution . Hyaluronic acid is a widely used tear substitute prescribed for the same indication. Arabinogalactan is a new class 1 medical device according to the European rules. This study is the first clinical trial using arabinogalactan ophthalmic formulation 5% as test product.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33541 0
Address 33541 0
Country 33541 0
Phone 33541 0
Fax 33541 0
Email 33541 0
Contact person for public queries
Name 16788 0
Pino Fioravanti MD
Address 16788 0
Hippocrates-Research
via XX settembre, 30
16121 Genova
Country 16788 0
Italy
Phone 16788 0
+39 010 545481
Fax 16788 0
+39 5454830
Email 16788 0
p.fioravanti@hippocrates-research.it
Contact person for scientific queries
Name 7716 0
Pino Fioravanti MD
Address 7716 0
Hippocrates-Research
via XX settembre, 30
16121 Genova
Country 7716 0
Italy
Phone 7716 0
+39 010 545481
Fax 7716 0
+39 5454830
Email 7716 0
p.fioravanti@hippocrates-research.it

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary