Dry EyeNCT01363414
Sodium Hyaluronate and Wavefront Aberrations in Dry Eyes
A study testing 0.18% sodium hyaluronate and 0.9% sodium chloride solution in people with Dry Eye, run by Ramathibodi Hospital at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dry Eye
- What is being tested?
- 0.18% sodium hyaluronate and 0.9% sodium chloride solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2007to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the detailed description
Parameters used to determine treatment outcomes included ocular aberrations and severity of dry eye symptoms.
- Conditions
- Dry Eye
- Being tested
- 0.18% sodium hyaluronate, 0.9% sodium chloride solution
- Keywords
- Dry eye, Ocular aberration
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.18% sodium hyaluronateDrug
Also called Vislube®/ Vismed®
one drop of preservative-free, hypotonic 0.18% sodium hyaluronate in one eye
0.9% sodium chloride solutionDrug
Also called 0.9% NSS
one drop of sterile 0.9% sodium chloride solution in the other eye
| Study group | Role | What they receive |
|---|---|---|
| Artificial tear | Experimental | One drop of preservative-free, hypotonic 0.18% sodium hyaluronate in one eye Receives: Drug: 0.18% sodium hyaluronate |
| Control | Placebo comparator | one drop of sterile 0.9% sodium chloride solution in the other eye Receives: Drug: 0.9% sodium chloride solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 120 minutes
Secondary outcomes (2)
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)
Measured: 120 minutes
Adverse reactions and complications
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2011 (estimated)
- Study startJan 2007
- Primary completionJun 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Kaevalin Lekhnaont, MD, Principal investigator, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01363414
- Sponsor's protocol ID
- SVS20-THAI-05-01
- Status last verified
- Sep 2010
- First submitted
- 27 May 2011
- Last updated
- 1 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24366433
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of the Effects of Sodium Hyaluronate on Wavefront Aberrations in Dry Eye Patients
- ClinicalTrials.gov ID
- NCT01363414
- Acronym / sponsor ID
- SVS20-THAI-05-01
- Conditions
- Dry Eye
- Keywords
- Dry eye, Ocular aberration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 1 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artificial tear | Experimental | Drug: 0.18% sodium hyaluronateOne drop of preservative-free, hypotonic 0.18% sodium hyaluronate in one eye |
| Control | Placebo comparator | Drug: 0.9% sodium chloride solutionone drop of sterile 0.9% sodium chloride solution in the other eye |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.18% sodium hyaluronateAlso: Vislube®/ Vismed®one drop of preservative-free, hypotonic 0.18% sodium hyaluronate in one eye | Drug | Artificial tear |
| 0.9% sodium chloride solutionAlso: 0.9% NSSone drop of sterile 0.9% sodium chloride solution in the other eye | Drug | Control |
Primary outcome
Ocular aberrations
Time frame: 120 minutes
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.
2 secondary outcomes
Severity of dry eye symptoms
Time frame: 120 minutes
Adverse reactions and complications
Time frame: 120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2011.
- Derived from this study: PubMed 24366433Lekhanont 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaevalin Lekhnaont, MD principal investigator
Ramathibodi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.18% sodium hyaluronate and 0.9% sodium chloride solution in people with Dry Eye, run by Ramathibodi Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular aberrations (time frame: 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01363414, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2011.