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Completed

NCT Number: NCT01363414

Sodium Hyaluronate and Wavefront Aberrations in Dry Eyes

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ramathibodi Hospital

Bangkok, 10400, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients aged 18 years or over.
  • Documented history of bilateral dry eye for at least 3 months.
  • Schirmer's I test (without anesthesia) less than 10 mm wetting/5 minutes for each eye.
  • Tear film break-up time (TBUT) less than 10 seconds for each eye.
  • Good compliance with the study regimen and availability for the duration of the entire study period.

Exclusion criteria

  • Pregnant or lactating women.
  • Contact lens wear.
  • Non-mydriatic pupil size less than 5.0 mm.
  • Other ocular surface pathologies or coexisting ocular diseases.
  • Ocular surgery or trauma within the past 4 months.
  • Use of concomitant eye drops or eye ointments within the past 2 weeks.
  • Abnormality of the nasolacrimal drainage apparatus.
  • Permanent or temporary occlusion of lacrimal puncta in any eye.
  • Known hypersensitivity to hyaluronic acid or any component used in the study.
  • 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.
  • Very severe dry eye causing inaccurate aberrometry measurements.

Treatment and study plan

0.18% sodium hyaluronate

Drug

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

Other names: Vislube®/ Vismed®

0.9% sodium chloride solution

Drug

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

Other names: 0.9% NSS

Primary outcomes

  1. Ocular aberrations

    Time frame: 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 outcomes

  1. Severity of dry eye symptoms

    Time frame: 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

    Time frame: 120 minutes

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Ramathibodi Hospital

Other

Registry information

Official study title

Randomized Controlled Trial of the Effects of Sodium Hyaluronate on Wavefront Aberrations in Dry Eye Patients

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jun 1, 2011
Registry last updated
Jun 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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