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.

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?

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000121864

Acronym

Nil

Enrollment

Registered

2012-01-25

Start date

2009-12-16

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

Arabinogalactan monodose ophthalmic 5% (mass/volume percentage) solution, 4 drops per day, over a total of 2 months.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

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.

Outcome results