Sodium Hyaluronate and Wavefront Aberrations in Dry Eyes

NCT01363414 | Completed

• 1 other identifier: SVS20-THAI-05-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Keywords

Dry eye; Ocular aberration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Severity of dry eye symptoms

  120 minutes

• Adverse reactions and complications

  120 minutes

Study Arms (2)

Artificial tear

EXPERIMENTAL

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

Drug: 0.18% sodium hyaluronate

Control

PLACEBO COMPARATOR

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

Drug: 0.9% sodium chloride solution

Interventions

0.18% sodium hyaluronate DRUG

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

Also known as: Vislube®/ Vismed®

Artificial tear

0.9% sodium chloride solution DRUG

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

Also known as: 0.9% NSS

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ramathibodi Hospital: lead

Study Sites (1)

Ramathibodi Hospital

Bangkok, Bangkok, 10400, Thailand

Location

Related Publications (1)

• 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.

  PMID: 24366433 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Hyaluronic Acid; Sodium Chloride

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Kaevalin Lekhnaont, MD

  Ramathibodi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 27, 2011
• First Posted: June 1, 2011
• Study Start: January 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: September 1, 2010
• Last Updated: June 1, 2011

Record last verified: 2010-09

Locations

TH (1)