Back to results

Sodium Hyaluronate and Wavefront Aberrations in Dry Eyes

Primary Purpose

Dry Eye

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

0.18% sodium hyaluronate

0.9% sodium chloride solution

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring Dry eye, Ocular aberration

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Ramathibodi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Artificial tear

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Adverse reactions and complications

Full Information

NCT ID

NCT01363414

First Posted

May 27, 2011

Last Updated

May 31, 2011

Sponsor

Ramathibodi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01363414

Brief Title

Sodium Hyaluronate and Wavefront Aberrations in Dry Eyes

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2010

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Ramathibodi Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye

Keywords

Dry eye, Ocular aberration

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Artificial tear

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

0.18% sodium hyaluronate

Other Intervention Name(s)

Vislube®/ Vismed®

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

0.9% sodium chloride solution

Other Intervention Name(s)

0.9% NSS

Intervention Description

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

Primary Outcome Measure Information:

Title

Ocular aberrations

Description

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.

Time Frame

120 minutes

Secondary Outcome Measure Information:

Title

Severity of dry eye symptoms

Description

Time Frame

120 minutes

Title

Adverse reactions and complications

Time Frame

120 minutes

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kaevalin Lekhnaont, MD

Organizational Affiliation

Ramathibodi Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ramathibodi Hospital

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

12. IPD Sharing Statement

Citations:

PubMed Identifier

24366433

Citation

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.

Results Reference

derived

Learn more about this trial

Sodium Hyaluronate and Wavefront Aberrations in Dry Eyes

We'll reach out to this number within 24 hrs