Dry Eye SyndromePhase 3NCT01382225

Sodium Hyaluronate Ophthalmic Solution, 0.18% for Treatment of Dry Eye Syndrome

A Phase 3 study testing Sodium Hyaluronate Ophthalmic Solution, 0.18% in people with Dry Eye Syndrome, run by Alcon Research.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study was to determine if Sodium Hyaluronate, 0.18% is effective in treating the signs and symptoms of dry eye disease. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye Syndrome
What is being tested?: Sodium Hyaluronate Ophthalmic Solution, 0.18%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,936 participants
Where: No sites listed yet
Study dates: Jul 2011to May 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Documented history of dry eyes for at least 3 months.
Ocular discomfort due to dry eyes.
Presence of corneal and conjunctival staining.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Women who are pregnant or lactating.
Contact lens wear within 1 week before Screening and during the study.
Ocular surgery (of any type, including laser surgery) or ocular trauma within the 4 months prior to Screening.
Punctal plugs or punctal occlusion initiated within 3 months of screening
Other protocol-defined exclusion criteria may apply.

About this study

Official title: A Phase 3 Multicenter, Randomized, Controlled, Double-Masked Study of Safety and Efficacy of Sodium Hyaluronate Ophthalmic Solution, 0.18% in Dry Eye Syndrome

The purpose of this study was to determine if Sodium Hyaluronate, 0.18% is effective in treating the signs and symptoms of dry eye disease.

Conditions: Dry Eye Syndrome
Being tested: Sodium Hyaluronate Ophthalmic Solution, 0.18%, Vehicle
Keywords: Dry eyes, Ocular discomfort
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.

Sodium Hyaluronate Ophthalmic Solution, 0.18%Drug
VehicleOther
Inactive ingredients used as run-in and placebo comparator

Study groups in NCT01382225
Study group	Role	What they receive
Sodium Hyaluronate	Experimental	Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days Receives: Drug: Sodium Hyaluronate Ophthalmic Solution, 0.18%
Vehicle	Placebo comparator	Inactive ingredients, 1-2 drops instilled in each eye 3-6 times a day for 14 days Receives: Other: Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Lissamine Green Staining (LGS) Total Score at Day 7
The investigator instilled an ophthalmic dye on the eye and rated staining in three areas (cornea, nasal, and temporal conjunctiva). Staining was rated on a 5-point scale from 0 to 4 (0=0% to 4=>45%). The LGS Total Score (0-12) is the sum of the three individual ratings. A more negative change indicates a greater amount of improvement.
Measured: Baseline, Day 7
Change From Baseline in Global Symptom Frequency (GSF) Total Score at Day 7
The subject completed a questionnaire and rated the frequency of five common dry eye symptoms. Frequency was rated on a 4-point scale from 0 to 3 (0=never to 3=constantly). The GSF Total Score (0-15) is the sum of the five individual ratings. A more negative change indicates a greater amount of improvement.
Measured: Baseline, Day 7

Secondary outcomes (7)

Change From Baseline in LGS Total Score at Day 14
The investigator instilled an ophthalmic dye on the eye and rated staining in three areas (cornea, nasal, and temporal conjunctiva). Staining was rated on a 5-point scale from 0 to 4 (0=0% to 4=>45%). The LGS Total Score (0-12) is the sum of the three individual ratings. A more negative change indicates a greater amount of improvement.
Measured: Baseline, Day 14
Change From Baseline in GSF Total Score at Day 14
The subject completed a questionnaire and rated the frequency of five common dry eye symptoms. Frequency was rated on a 4-point scale from 0 to 3 (0=never to 3=constantly). The GSF Total Score (0-15) is the sum of the five individual ratings. A more negative change indicates a greater amount of improvement.
Measured: Baseline, Day 14
Percentage Change From Baseline in Corneal Fluorescein Staining (CFS) Total Score
The investigator instilled an ophthalmic dye on the eye and rated corneal staining by type, extent/surface area, and depth. Each staining was rated on a 5-point scale from 0 to 4 (0=no staining/0% to 4=patch/>45%/immediate diffuse stromal glow). The CFS Total Score (0-12) is the sum of the three individual ratings. A more negative percentage change indicates a greater amount of improvement.
Measured: Baseline, up to Day 14
Percentage Change From Baseline in Schirmer I Score
The investigator placed a paper strip on the eye under the lower lid and left it in place for 5 minutes. The Schirmer I Score was the length of the strip wetted by the tears (0-35 millimeters). A more positive percentage change indicates a greater amount of improvement.
Measured: Baseline, up to Day 14
Percentage Change From Baseline in Global Symptom Intensity (GSI) Total Score
The subject completed a questionnaire and rated the intensity of five common dry eye symptoms. Intensity was rated on a visual analog scale from 0-100 (0=no symptoms to 100=severe symptoms). The GSI Total Score (0 to 500) is the sum of the five individual ratings. A more negative percentage change indicates a greater amount of improvement.
Measured: Baseline, up to Day 14
Percentage Change From Baseline in Global Symptom Composite Index (GSCI) Score
For each of 5 common dry eye symptoms, the frequency (0-3) and intensity (0-100) scores were multiplied to obtain the symptom score (0-300). The 5 symptom scores were summed to obtain the Global Symptom Composite Index Score (0-1500). A more negative percentage change indicates a greater amount of improvement.
Measured: Baseline, up to Day 14
Proportion of Improved Scores on the Global Impact on Dry Eye Syndrome on Daily Life (GIDL) Rating
The subject was asked on a questionnaire, "Please consider how your dry eyes feel when doing daily activities such as working on the computer, watching television, reading, and driving. Based on this, please rate the impact of your dry eye symptoms on your daily life," and responded on a 4-point scale from 0-3 (0=Absent to 3=Severe). Improved was defined as a change in score of <0 from baseline. Proportion is reported as a percentage of participants. A greater percentage of subjects reporting a lower score indicates an improvement.
Measured: Baseline, Up to Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011May 2012

First posted27 Jun 2011 (estimated)
Study startJul 2011
Primary completionMay 2012
Study completionMay 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe sponsor's other registered studies.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,936 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01382225
Sponsor's protocol ID: C-09-045
Status last verified: May 2013
First submitted: 9 Jun 2011
Last updated: 8 Jul 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Dry Eye Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Multicenter, Randomized, Controlled, Double-Masked Study of Safety and Efficacy of Sodium Hyaluronate Ophthalmic Solution, 0.18% in Dry Eye Syndrome
ClinicalTrials.gov ID: NCT01382225
Acronym / sponsor ID: C-09-045
Conditions: Dry Eye Syndrome
Keywords: Dry eyes, Ocular discomfort
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,936 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 27 Jun 2011 (estimated)
Results: Posted 8 Jul 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study was to determine if Sodium Hyaluronate, 0.18% is effective in treating the signs and symptoms of dry eye disease.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Sodium Hyaluronate	Experimental	Drug: Sodium Hyaluronate Ophthalmic Solution, 0.18%Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
Vehicle	Placebo comparator	Other: VehicleInactive ingredients, 1-2 drops instilled in each eye 3-6 times a day for 14 days

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Documented history of dry eyes for at least 3 months.
Ocular discomfort due to dry eyes.
Presence of corneal and conjunctival staining.
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (5 listed)

Women who are pregnant or lactating.
Contact lens wear within 1 week before Screening and during the study.
Ocular surgery (of any type, including laser surgery) or ocular trauma within the 4 months prior to Screening.
Punctal plugs or punctal occlusion initiated within 3 months of screening
Other protocol-defined exclusion criteria may apply.

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
Sodium Hyaluronate Ophthalmic Solution, 0.18%	Drug	Sodium Hyaluronate
VehicleInactive ingredients used as run-in and placebo comparator	Other	Vehicle

Primary outcome

Change From Baseline in Lissamine Green Staining (LGS) Total Score at Day 7
Time frame: Baseline, Day 7
The investigator instilled an ophthalmic dye on the eye and rated staining in three areas (cornea, nasal, and temporal conjunctiva). Staining was rated on a 5-point scale from 0 to 4 (0=0% to 4=>45%). The LGS Total Score (0-12) is the sum of the three individual ratings. A more negative change indicates a greater amount of improvement.
Change From Baseline in Global Symptom Frequency (GSF) Total Score at Day 7
Time frame: Baseline, Day 7
The subject completed a questionnaire and rated the frequency of five common dry eye symptoms. Frequency was rated on a 4-point scale from 0 to 3 (0=never to 3=constantly). The GSF Total Score (0-15) is the sum of the five individual ratings. A more negative change indicates a greater amount of improvement.

7 secondary outcomes

Change From Baseline in LGS Total Score at Day 14
Time frame: Baseline, Day 14
Change From Baseline in GSF Total Score at Day 14
Time frame: Baseline, Day 14
Percentage Change From Baseline in Corneal Fluorescein Staining (CFS) Total Score
Time frame: Baseline, up to Day 14
Percentage Change From Baseline in Schirmer I Score
Time frame: Baseline, up to Day 14
Percentage Change From Baseline in Global Symptom Intensity (GSI) Total Score
Time frame: Baseline, up to Day 14
Percentage Change From Baseline in Global Symptom Composite Index (GSCI) Score
Time frame: Baseline, up to Day 14
Proportion of Improved Scores on the Global Impact on Dry Eye Syndrome on Daily Life (GIDL) Rating
Time frame: Baseline, Up to Day 14

Results and safety

Results posted to the registry on 8 Jul 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sodium Hyaluronate	725	711
Vehicle	729	722

Primary outcome: Change From Baseline in Lissamine Green Staining (LGS) Total Score at Day 7

Time frame: Baseline, Day 7. Mean (Standard Deviation). Unit: Units on a scale

Measure	Sodium Hyaluronate n = 643	Vehicle n = 648
Baseline	4.9 (2.2)	4.8 (2.1)
Change from Baseline at Day 7	-0.8 (1.8)	-0.7 (1.6)

Population analysed: Modified Intent-to-Treat (mITT): The set of all randomized subjects who received at least one administration of the allocated product, had baseline efficacy measurement, had at least 1 post-baseline measurement and received the correct formulation of the lissamine green solution.

Primary outcome: Change From Baseline in Global Symptom Frequency (GSF) Total Score at Day 7

Time frame: Baseline, Day 7. Mean (Standard Deviation). Unit: Units on a scale

Measure	Sodium Hyaluronate n = 643	Vehicle n = 648
Baseline	8.9 (2.3)	9.1 (2.3)
Change from Baseline at Day 7	-1.6 (2.6)	-1.3 (2.4)

Population analysed: Modified Intent-to-Treat

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected for the duration of the study. The safety population includes all randomized subjects who receive exposure to study medication or had potential exposure.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sodium Hyaluronate	1 of 723 (0.1%)	0 of 723 (0%)	Not reported
Vehicle	1 of 727 (0.1%)	0 of 727 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dry Eye Syndrome

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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.

Michela Montecchi-Palmer, BS study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sodium Hyaluronate Ophthalmic Solution, 0.18% in people with Dry Eye Syndrome, run by Alcon Research.

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 4 inclusion and 5 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 8 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Lissamine Green Staining (LGS) Total Score at Day 7 (time frame: Baseline, Day 7). The study lists 2 primary outcomes in all. 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 NCT01382225.

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 8 Jul 2013.