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Sodium Hyaluronate and Wavefront Aberrations in Dry Eyes

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ClinicalTrials.gov Identifier: NCT01363414
Recruitment Status : Completed
First Posted : June 1, 2011
Last Update Posted : June 1, 2011
Sponsor:
Information provided by:
Ramathibodi Hospital

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
Dry Eye Drug: 0.18% sodium hyaluronate Drug: 0.9% sodium chloride solution Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
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 : January 2007
Actual Primary Completion Date : June 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 0.9% NSS




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363414


Locations
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Thailand
Ramathibodi Hospital
Bangkok, Thailand, 10400
Sponsors and Collaborators
Ramathibodi Hospital
Investigators
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Principal Investigator: Kaevalin Lekhnaont, MD Ramathibodi Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kaevalin Lekhanont, Department of Ophthalmology, Ramathibodi Hospital
ClinicalTrials.gov Identifier: NCT01363414     History of Changes
Other Study ID Numbers: SVS20-THAI-05-01
First Posted: June 1, 2011    Key Record Dates
Last Update Posted: June 1, 2011
Last Verified: September 2010

Keywords provided by Ramathibodi Hospital:
Dry eye
Ocular aberration

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents