Sodium Hyaluronate and Wavefront Aberrations in Dry Eyes

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01363414
• Other study ID #: SVS20-THAI-05-01
• Status: Completed
• Phase: N/A
• First received: May 27, 2011
• Last updated: May 31, 2011
• Start date: January 2007
• Est. completion date: September 2010

Study information

• Verified date: September 2010
• Source: Ramathibodi Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• 0.18% sodium hyaluronate
one drop of preservative-free, hypotonic 0.18% sodium hyaluronate in one eye
• 0.9% sodium chloride solution
one drop of sterile 0.9% sodium chloride solution in the other eye

Locations

Country	Name	City	State
Thailand	Ramathibodi Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Ramathibodi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular aberrations	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.	120 minutes	No
Secondary	Severity of dry eye symptoms	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)	120 minutes	No
Secondary	Adverse reactions and complications		120 minutes	Yes