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Sodium Hyaluronate and Wavefront Aberrations in Dry Eyes

Sponsor
Ramathibodi Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01363414
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
44
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Eyes with abnormal tear film function have been found to show larger optical aberrations than normal eyes which may be attributed to the unstable and irregular tear film, uneven ocular surface, and increased scatter due to the exposure of the rough surface of corneal epithelium after tear break-up.

These hypotheses have been supported by the findings that instillation of artificial tears (sodium hyaluronate preparation) in dry eye patients reduces both corneal and ocular aberrations, improving the optical quality of the retinal image.

However, the previous studies only evaluated the short-term effects of a single administration of an artificial tear but did not determine the duration of action or inflection point at which the ocular aberrations increase back to baseline. Also, there has clearly been no such clinical trial that has been a well randomized controlled study to date.

This report is the first randomized controlled trial that investigated the long-term effects of a single dose of sodium hyaluronate-based artificial tears on wavefront aberrations in patients with dry eye.

Condition or Disease Intervention/Treatment Phase
  • Drug: 0.18% sodium hyaluronate
  • Drug: 0.9% sodium chloride solution
 N/A

Detailed Description

Parameters used to determine treatment outcomes included ocular aberrations and severity of dry eye symptoms.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Randomized Controlled Trial of the Effects of Sodium Hyaluronate on Wavefront Aberrations in Dry Eye Patients
Study Start Date :
Jan 1, 2007
Actual Primary Completion Date :
Jun 1, 2010
Actual Study Completion Date :
Sep 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Artificial tear

One drop of preservative-free, hypotonic 0.18% sodium hyaluronate in one eye

Drug: 0.18% sodium hyaluronate
one drop of preservative-free, hypotonic 0.18% sodium hyaluronate in one eye
Other Names:
  • Vislube®/ Vismed®

    		•
    Placebo Comparator: Control

    one drop of sterile 0.9% sodium chloride solution in the other eye

    Drug: 0.9% sodium chloride solution
    one drop of sterile 0.9% sodium chloride solution in the other eye
    Other Names:
  • 0.9% NSS

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ocular aberrations [120 minutes]

      A Zywave® II aberrometer which is a wavefront-sensing device based on the Hartmann-Shack principle was used to analyze monochromatic wavefront aberrations of the whole eye.

    Secondary Outcome Measures

    1. Severity of dry eye symptoms [120 minutes]

      Dry eye symptoms in both eyes were graded separately by an interview based on a questionnaire inquiring about 12 symptoms: soreness, scratchiness, dryness, grittiness, burning, itchiness, ocular fatigue, lid heaviness, blurred vision, photophobia, discharge, and excess tearing, using a 0-100 mm visual analogue scale (VAS) (0 = no symptoms to 100 = severe symptoms)

    2. Adverse reactions and complications [120 minutes]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Male or female patients aged 18 years or over.

    2. Documented history of bilateral dry eye for at least 3 months.

    3. Schirmer's I test (without anesthesia) less than 10 mm wetting/5 minutes for each eye.

    4. Tear film break-up time (TBUT) less than 10 seconds for each eye.

    5. Good compliance with the study regimen and availability for the duration of the entire study period.

    Exclusion Criteria:

    1. Pregnant or lactating women.

    2. Contact lens wear.

    3. Non-mydriatic pupil size less than 5.0 mm.

    4. Other ocular surface pathologies or coexisting ocular diseases.

    5. Ocular surgery or trauma within the past 4 months.

    6. Use of concomitant eye drops or eye ointments within the past 2 weeks.

    7. Abnormality of the nasolacrimal drainage apparatus.

    8. Permanent or temporary occlusion of lacrimal puncta in any eye.

    9. Known hypersensitivity to hyaluronic acid or any component used in the study.

    10. Taking the following systemic medications within the previous 2 months: tricyclic antidepressive agents, anti-histaminic agents, phenothiazines, cholinergic agents, antimuscarinic agents, NSAIDs, beta-blockers, immunomodulators, anti-acneic agents, diuretics, corticosteroids and tetracyclines.

    11. Very severe dry eye causing inaccurate aberrometry measurements.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ramathibodi Hospital Bangkok Thailand 10400

    Sponsors and Collaborators

    • Ramathibodi Hospital

    Investigators

    • Principal Investigator: Kaevalin Lekhnaont, MD, Ramathibodi Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01363414
    Other Study ID Numbers:
    • SVS20-THAI-05-01
    First Posted:
    Jun 1, 2011
    Last Update Posted:
    Jun 1, 2011
    Last Verified:
    Sep 1, 2010
    Keywords provided by , ,
    Dry eye
    Ocular aberration
    Additional relevant MeSH terms:
    Dry Eye Syndromes
    Keratoconjunctivitis Sicca
    Hyaluronic Acid

    Study Results

    No Results Posted as of Jun 1, 2011