Sodium Hyaluronate and Wavefront Aberrations in Dry Eyes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2010-09-30

Brief Summary

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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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Detailed Description

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

Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Artificial tear

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

Group Type EXPERIMENTAL

0.18% sodium hyaluronate

Intervention Type DRUG

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

Control

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

Group Type PLACEBO_COMPARATOR

0.9% sodium chloride solution

Intervention Type DRUG

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

Interventions

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0.18% sodium hyaluronate

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

Intervention Type DRUG

0.9% sodium chloride solution

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

Intervention Type DRUG

Other Intervention Names

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Vislube®/ Vismed® 0.9% NSS

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No