Sodium Hyaluronate and Wavefront Aberrations in Dry Eyes

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Drug: 0.18% sodium hyaluronate; Drug: 0.9% sodium chloride solution

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Ramathibodi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Adverse reactions and complications		120 minutes

Collaborators and Investigators

• Sponsor: Ramathibodi Hospital
• Investigators: Principal Investigator: Kaevalin Lekhnaont, MD, Ramathibodi Hospital

Publications and helpful links

General Publications

• Lekhanont K, Chuckpaiwong V, Vongthongsri A, Sangiampornpanit T. Effects of sodium hyaluronate on wavefront aberrations in dry eye patients. Optom Vis Sci. 2014 Jan;91(1):39-46. doi: 10.1097/OPX.0000000000000101.

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: May 27, 2011
• First Submitted That Met QC Criteria: May 31, 2011
• First Posted (Estimate): June 1, 2011

Study Record Updates

• Last Update Posted (Estimate): June 1, 2011
• Last Update Submitted That Met QC Criteria: May 31, 2011
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Dry eye; Ocular aberration
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: SVS20-THAI-05-01