Dry Eye SyndromesPhase 4NCT00761202
Performance and Acceptance of Optive Versus Hylocomod Eyedrops in Patients With Dry Eye Symptoms
A Phase 4 study testing A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE® and Sodium hyaluronate in people with Dry Eye Syndromes, run by Allergan at 1 site in United Kingdom.
Trial summary
This study evaluates the performance and acceptance of Optive versus Hylocomod eyedrops, when administered for one month to patients with mild to moderate dry eye symptoms, with and without contact lenses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE® and Sodium hyaluronate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2007to Jun 2008
- Phase
- Phase 4
- 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
- 18 years or over
- Contact lens wearer, spectacle wearer or non-spectacle wearer
- Mild to severe dry eye symptoms, defined as OSDI score 13 to 100
- Mild to moderate conjunctival staining in each eye and/or mild to moderate corneal staining in each eye
- Best corrected visual acuity of 6/9 in each eye
Who cannot join
- Previously used Hylocomod or Optive eyedrops
- Systemic allergy or eye allergy
- Systemic disease which might have an ocular component and/or interfere with contact lens wear
- Autoimmune disease which might have an ocular component and/or interfere with contact lens wear
- Systemic medication which might have eye side effects and or interfere with contact lens wear
- Eye infection or use of eye medication
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the performance and acceptance of Optive versus Hylocomod eyedrops, when administered for one month to patients with mild to moderate dry eye symptoms, with and without contact lenses.
- Conditions
- Dry Eye Syndromes
- Being tested
- A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE®, Sodium hyaluronate
- 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.
A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE®Drug
Also called Optive™ Eyedrops
Eyedrops as required, but at least 3 times per day
Sodium hyaluronateDrug
Also called Hylocomod
Eyedrops as required, but at least 3 times per day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Optive Eyedrops Receives: Drug: A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE® |
| 2 | Active comparator | Hylocomod Eyedrops Receives: Drug: Sodium hyaluronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conjunctival Staining by Lissamine Green
Percentage of cases of limbal staining by lissamine green at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe)
Measured: week 1, month 1
Secondary outcomes (5)
Corneal Staining by Fluorescein
Percentage of cases of limbal staining by sodium fluorescein at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe)
Measured: week 1, month 1
Conjunctival Hyperaemia
Percentage of conjunctival response reported in terms of limbal hyperaemia for the worst responses over the area at each point on a five point scale (0=clear/white conjunctiva, 1=slight redness, 2=Mild redness, 3=Moderate redness, 4=Severe redness)
Measured: week 1, month 1
Ocular Comfort and Ocular Symptoms on Visual Analogue Scale
Mean comfort judged on a 100 point visual analogue scale (0=Very Poor, 100=Excellent)
Measured: week 1, month 1
Daily Eyedrop Usage
Average daily eyedrop use
Measured: Month 1
Lipid Layer Pattern Assessment
Lipid layer thickness as determined by lipid layer mixing pattern. A high mixing pattern = thick lipid layer.
Measured: Week 1, month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2008 (estimated)
- Study startAug 2007
- Primary completionJun 2008
- Study completionJun 2008
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 SyndromesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761202
- Sponsor's protocol ID
- AGN/OPH/DE/002
- Status last verified
- Oct 2013
- First submitted
- 25 Sep 2008
- Last updated
- 19 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance and Acceptance of Optive Versus Hylocomod Eyedrops in Patients With Dry Eye Symptoms
- ClinicalTrials.gov ID
- NCT00761202
- Acronym / sponsor ID
- AGN/OPH/DE/002
- Conditions
- Dry Eye Syndromes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 29 Sep 2008 (estimated)
- Results
- Posted 4 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the performance and acceptance of Optive versus Hylocomod eyedrops, when administered for one month to patients with mild to moderate dry eye symptoms, with and without contact lenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE®Optive Eyedrops |
| 2 | Active comparator | Drug: Sodium hyaluronateHylocomod Eyedrops |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or over
- Contact lens wearer, spectacle wearer or non-spectacle wearer
- Mild to severe dry eye symptoms, defined as OSDI score 13 to 100
- Mild to moderate conjunctival staining in each eye and/or mild to moderate corneal staining in each eye
- Best corrected visual acuity of 6/9 in each eye
Key exclusion criteria (6 listed)
- Previously used Hylocomod or Optive eyedrops
- Systemic allergy or eye allergy
- Systemic disease which might have an ocular component and/or interfere with contact lens wear
- Autoimmune disease which might have an ocular component and/or interfere with contact lens wear
- Systemic medication which might have eye side effects and or interfere with contact lens wear
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 |
|---|---|---|
| A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE®Also: Optive™ EyedropsEyedrops as required, but at least 3 times per day | Drug | 1 |
| Sodium hyaluronateAlso: HylocomodEyedrops as required, but at least 3 times per day | Drug | 2 |
Primary outcome
Conjunctival Staining by Lissamine Green
Time frame: week 1, month 1
Percentage of cases of limbal staining by lissamine green at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe)
5 secondary outcomes
Corneal Staining by Fluorescein
Time frame: week 1, month 1
Conjunctival Hyperaemia
Time frame: week 1, month 1
Ocular Comfort and Ocular Symptoms on Visual Analogue Scale
Time frame: week 1, month 1
Daily Eyedrop Usage
Time frame: Month 1
Lipid Layer Pattern Assessment
Time frame: Week 1, month 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Dry Eye Syndromes
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)
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.
Medical Director study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE® and Sodium hyaluronate in people with Dry Eye Syndromes, run by Allergan at 1 site in United Kingdom.
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 6 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 19 Nov 2013. 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 United Kingdom. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 4 Feb 2010). 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?
Conjunctival Staining by Lissamine Green (time frame: week 1, month 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2013.