Dry Eye SyndromesPhase 4LIPCOFNCT01268735
The Effect of Ocular Lubricant Eyedrops on Lid Parallel Conjunctival Folds and Other Signs and Symptoms of Dry Eye
A Phase 4 study testing Lubricating eyedrops containing hydroxypropyl-guar in people with Dry Eye Syndromes, run by University of Zagreb at 1 site in Croatia.
Trial summary
Purpose To try to establish whether lid-parallel conjunctival folds (LIPCOF) can be influenced by increased lubrication with rewetting and lubricating eyedrops containing hydroxypropyl-guar, which has proven lubricating effect. 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?
- Lubricating eyedrops containing hydroxypropyl-guar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 1 siteCroatia
- Study dates
- Apr 2009to Feb 2010
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ocular foreign body sensation, burning or stinging, complaints more pronounced in winter, windy conditions, during computer work, being bilateral, of the duration longer than three months, visual acuity fluctuations depending on blinking after longer reading or computer work, and tearing in cold weather, in the morning, after longer reading or computer work. Patients were also asked whether the symptoms were more pronounced in the morning or evening. The main enrollment criterion was the score of the above listed symptoms 15 or higher.
Who cannot join
- Pregnant women, children, chronic eye patients on continuous topical therapy during previous month (i.e.glaucoma) and patients suffering from any acute eye disease and therefore on topical or systemic therapy in the previous month were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Ocular Surface Lubricant Eyedrops on Lid Parallel Conjunctival Folds (LIPCOF) and Other Signs and Symptoms of Dysfunctional Tear Syndrome
Purpose To try to establish whether lid-parallel conjunctival folds (LIPCOF) can be influenced by increased lubrication with rewetting and lubricating eyedrops containing hydroxypropyl-guar, which has proven lubricating effect.
Methods During summer and fall of 2009, 16 ophthalmologists from various regions of Croatia investigated the effect of topical therapy with lubricating eyedrops on the signs and symptoms of dry eye, with the special emphasis on lid-parallel conjunctival folds (LIPCOF). 229 patients were enrolled in the study.
Read more
Results After 14 days of therapy with lubricating eyedrops containing hydroxypropyl-guar, statistically significant reduction of LIPCOF grade was observed, as well as the reduction of symptoms and other signs of dysfunctional tear syndrome (TBUT, Schirmer test, conjunctival hyperemia).
Conclusion Results of this study have shown positive influence of lubricating eyedrops containing hydroxypropyl-guar on signs and symptoms of dysfunctional tear syndrome even after only 14 days of treatment. It is of particular interest that LIPCOF grade was statistically significantly decreased, pointing at increased friction and decreased ocular surface lubrication as possible causes of its appearance.
Having this in mind, every clinician involved in dysfunctional tear syndrome treatment must also think about lubrication as integral part of treating this condition.
Read the detailed description
Ruprecht et al. (1976-78) were among the first to ask a general population a simple question: "do you have gritty sensation in your eyes?". The results have shown that in the age group 55-59, 22,8% females and 9,9% males reported this symptom. In the age group 45-54 years, almost 20% of females and 15% of males also had dry eye signs. Based on reported symptoms, Schirmer test, TBUT test or Rose Bengal Staining, Jacobssson et al. in their survey among 780 subjects belonging to general population in Sweden have found that prevalence of dry eye in the age group 55-72 years was 15%. In the more recent study by Hikichi et al. in Japan, which screened 2127 patients in eight medical centers, dry eye symptoms were found among 17% of them. No seasonal fluctuations were observed. Survey on 504 subjects aged 30-60 in Kopenhagen has revealed the prevalence of dry eye in 11% of them. In a larger study in Maryland, USA, involving 2520 residents older than 65, 15% reported one or more dry eye symptoms, but only 2.2% of them also had pathological Schirmer test.
Mentioned studies have shown that dry eye symptoms were most prevalent in the age group older than 50, although no correlation was found between the age and gender. McCarthy et al. analyzed the prevalence of dry eye in Melbourne (Australia). 926 participants older than 40 were enrolled in the survey. Dry eye was diagnosed in 10.8% of subjects by Rose Bengal staining, in 16.3% of them by Schirmer test, 8.6% by TBUT test, 1.5% by fluorescein staining, in 7.4 of subjects by using two or more tests, and in 5.5% of subjects with the extreme symptoms of dry eye unrelated to hay fever. Women reported dry eye symptoms more frequently than men. Canadian Dry Eye Epidemiology Study (CANDEES) tried to establish the prevalence of dry eye in Canada. Questionnaires were mailed to every optometrist in Canada, who were asked to hand them out to 30 consecutive patients. The total of 13.517 completed questionnaires were returned (15.6% of those sent out). All age groups were enrolled in the study. 55% of subjects were in the age group 21-50, 60.7% were women, and 24.3% of them wore contact lenses. Dry eye symptoms were reported by 28.7% of surveyed subjects. When asked to describe the severity of symptoms, 7.6% reported moderate but constant symptoms, while 1.6% of them described them as severe. It is interesting to note that the vast majority of subjects who reported having severe symptoms were women (ratio women to men: 46:1). Regarding gender, 33% of women and 22% of men reported dry eye symptoms. Salisbury Study (1997) found dry eye symptoms in 59% of surveyed subjects. In Beaver Dam Eye Study (2000) 14,4% out of 3703 surveyed subjects had dry eye symptoms11. Part of this study was to analyze possible association of dry eye symptoms with other parameters. Statistically significant and independent association was found between dry eye symptoms and arthritis, smoking, coffee drinking, hyperthyreosis, goiter, diabetes and taking multivitamin food supplements.
When analyzing causes of first visits to the general outpatient office in Zagreb University Hospital Eye Department, 6.3% of all patients reported dysfunctional tear syndrome symptoms as their primary cause for visit. That percentage rose to 48% when only patients with external eye disease symptoms were analyzed, and would no doubt be even higher if only chronic external eye inflammatory conditions were counted.
Group of authors led by Prof.Hoeh 1995 published the paper Lid-parallel conjunctival folds are a sure diagnostic sign of dry eye. The method described was named Lidkantenparallelen Konjunktivalen Falten, or Lid Parallel Conjunctival Folds (LIPCOF). It was presented as a very useful and innovative way of diagnosing dry eye. However, it was up till now mentioned in relatively few published papers and is rarely used in everyday clinical practice, especially outside Europe, where it is frequently termed conjunctivochalasis and not associated with dry eye.
According to authors, the height and/or number of bulbar conjunctival folds parallel to the temporal margin of the lower eyelid are observed. Before assessment, lower eyelid is briefly lifted from the eye surface- if folds disappear, they indeed are what is described as LIPCOF.
Findings are ranked as follows:
Grade 0: no folds- normal finding (not dry eye) Grade 1: one fold above the normal tear meniscus height- mild dry eye Grade 2: multiple folds up to the height of normal tear meniscus- moderately dry eye Grade 3: multiple folds above normal tear meniscus height- severe dry eye Authors claim that LIPCOF has 93% positive predictive value. In other words, it detects dry eye with 93% certainty. Its negative predictive value is claimed to be 76%. Furthermore, LIPCOF is not invasive, takes very short time to perform and has no additional costs, as it requires use of no test strips, dyes etc.
Despite all mentioned advantages of this method, we still do not know what it actually measures- proven correlation between conjunctival folds and other signs and symptoms of dry eye does not automatically point at the reasons of their appearance.
One of the possible causes of LIPCOF may be decreased lubrication and increased friction of ocular surface and eyelids during blinking in dysfunctional tear syndrome. The importance of friction between the upper eyelid and ocular surface was well described by Korb in his Lid Wiper Epitheliopathy concept.
Nowadays, we have at our disposal commercially available rewetting eyedrops which, due to their formulation, display proven lubricating effect as well. If their application reduces LIPCOF grade, then increased friction may be the cause of the appearance of folds. Furthermore, such finding may show that this sign of dysfunctional tear syndrome may be influenced by appropriate therapy.
The aim of this study was to try to establish whether LIPCOF can be influenced by increased lubrication with rewetting and lubricating eyedrops containing hydroxypropyl-guar which has proven lubricating effect. Should that be the case, then it may be concluded that conjunctival folds appear due to the increased friction, and that they are dynamic condition, reversible after appropriate therapy. The influence of lubrication on other signs and symptoms of dry eye was also observed.
- Conditions
- Dry Eye Syndromes
- Being tested
- Lubricating eyedrops containing hydroxypropyl-guar
- Keywords
- Dysfunctional Tear Syndrome, Dry Eye, LIPCOF, Hydroxypropyl-guar
- 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.
Lubricating eyedrops containing hydroxypropyl-guarDrug
Also called Systane lubricating eyedrops, ALCON
Eyedrops BID
| Study group | Role | What they receive |
|---|---|---|
| Lubricating eyedrops containing HP-guar | Experimental | Not described Receives: Drug: Lubricating eyedrops containing hydroxypropyl-guar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lid-parallel conjunctival folds (LIPCOF)
The effect of topical therapy with lubricating eyedrops on lid-parallel conjunctival folds (LIPCOF).
Measured: 14 days
Secondary outcomes (1)
Signs and symptoms of dry eye
The effect of topical therapy with lubricating eyedrops on the signs and symptoms of dry eye.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2010 (estimated)
- Study startApr 2009
- Primary completionSep 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Investigators
- Igor Petricek, MD, Principal investigator, Zagreb University Hospital Eye Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268735
- Sponsor's protocol ID
- LIPCOF Petricek
- Acronym
- LIPCOF
- Status last verified
- Dec 2010
- First submitted
- 30 Dec 2010
- Last updated
- 31 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ocular Surface Lubricant Eyedrops on Lid Parallel Conjunctival Folds (LIPCOF) and Other Signs and Symptoms of Dysfunctional Tear Syndrome
- ClinicalTrials.gov ID
- NCT01268735
- Acronym / sponsor ID
- LIPCOF / LIPCOF Petricek
- Conditions
- Dry Eye Syndromes
- Keywords
- Dysfunctional Tear Syndrome, Dry Eye, LIPCOF, Hydroxypropyl-guar
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 31 Dec 2010 (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.
Purpose To try to establish whether lid-parallel conjunctival folds (LIPCOF) can be influenced by increased lubrication with rewetting and lubricating eyedrops containing hydroxypropyl-guar, which has proven lubricating effect.
Methods During summer and fall of 2009, 16 ophthalmologists from various regions of Croatia investigated the effect of topical therapy with lubricating eyedrops on the signs and symptoms of dry eye, with the special emphasis on lid-parallel conjunctival folds (LIPCOF). 229 patients were enrolled in the study.
Results After 14 days of therapy with lubricating eyedrops containing hydroxypropyl-guar, statistically significant reduction of LIPCOF grade was observed, as well as the reduction of symptoms and other signs of dysfunctional tear syndrome (TBUT, Schirmer test, conjunctival hyperemia).
Conclusion Results of this study have shown positive influence of lubricating eyedrops containing hydroxypropyl-guar on signs and symptoms of dysfunctional tear syndrome even after only 14 days of treatment. It is of particular interest that LIPCOF grade was statistically significantly decreased, pointing at increased friction and decreased ocular surface lubrication as possible causes of its appearance.
Having this in mind, every clinician involved in dysfunctional tear syndrome treatment must also think about lubrication as integral part of treating this condition.
Detailed description
Ruprecht et al. (1976-78) were among the first to ask a general population a simple question: "do you have gritty sensation in your eyes?". The results have shown that in the age group 55-59, 22,8% females and 9,9% males reported this symptom. In the age group 45-54 years, almost 20% of females and 15% of males also had dry eye signs. Based on reported symptoms, Schirmer test, TBUT test or Rose Bengal Staining, Jacobssson et al. in their survey among 780 subjects belonging to general population in Sweden have found that prevalence of dry eye in the age group 55-72 years was 15%. In the more recent study by Hikichi et al. in Japan, which screened 2127 patients in eight medical centers, dry eye symptoms were found among 17% of them. No seasonal fluctuations were observed. Survey on 504 subjects aged 30-60 in Kopenhagen has revealed the prevalence of dry eye in 11% of them. In a larger study in Maryland, USA, involving 2520 residents older than 65, 15% reported one or more dry eye symptoms, but only 2.2% of them also had pathological Schirmer test.
Mentioned studies have shown that dry eye symptoms were most prevalent in the age group older than 50, although no correlation was found between the age and gender. McCarthy et al. analyzed the prevalence of dry eye in Melbourne (Australia). 926 participants older than 40 were enrolled in the survey. Dry eye was diagnosed in 10.8% of subjects by Rose Bengal staining, in 16.3% of them by Schirmer test, 8.6% by TBUT test, 1.5% by fluorescein staining, in 7.4 of subjects by using two or more tests, and in 5.5% of subjects with the extreme symptoms of dry eye unrelated to hay fever. Women reported dry eye symptoms more frequently than men. Canadian Dry Eye Epidemiology Study (CANDEES) tried to establish the prevalence of dry eye in Canada. Questionnaires were mailed to every optometrist in Canada, who were asked to hand them out to 30 consecutive patients. The total of 13.517 completed questionnaires were returned (15.6% of those sent out). All age groups were enrolled in the study. 55% of subjects were in the age group 21-50, 60.7% were women, and 24.3% of them wore contact lenses. Dry eye symptoms were reported by 28.7% of surveyed subjects. When asked to describe the severity of symptoms, 7.6% reported moderate but constant symptoms, while 1.6% of them described them as severe. It is interesting to note that the vast majority of subjects who reported having severe symptoms were women (ratio women to men: 46:1). Regarding gender, 33% of women and 22% of men reported dry eye symptoms. Salisbury Study (1997) found dry eye symptoms in 59% of surveyed subjects. In Beaver Dam Eye Study (2000) 14,4% out of 3703 surveyed subjects had dry eye symptoms11. Part of this study was to analyze possible association of dry eye symptoms with other parameters. Statistically significant and independent association was found between dry eye symptoms and arthritis, smoking, coffee drinking, hyperthyreosis, goiter, diabetes and taking multivitamin food supplements.
When analyzing causes of first visits to the general outpatient office in Zagreb University Hospital Eye Department, 6.3% of all patients reported dysfunctional tear syndrome symptoms as their primary cause for visit. That percentage rose to 48% when only patients with external eye disease symptoms were analyzed, and would no doubt be even higher if only chronic external eye inflammatory conditions were counted.
Group of authors led by Prof.Hoeh 1995 published the paper Lid-parallel conjunctival folds are a sure diagnostic sign of dry eye. The method described was named Lidkantenparallelen Konjunktivalen Falten, or Lid Parallel Conjunctival Folds (LIPCOF). It was presented as a very useful and innovative way of diagnosing dry eye. However, it was up till now mentioned in relatively few published papers and is rarely used in everyday clinical practice, especially outside Europe, where it is frequently termed conjunctivochalasis and not associated with dry eye.
According to authors, the height and/or number of bulbar conjunctival folds parallel to the temporal margin of the lower eyelid are observed. Before assessment, lower eyelid is briefly lifted from the eye surface- if folds disappear, they indeed are what is described as LIPCOF.
Findings are ranked as follows:
Grade 0: no folds- normal finding (not dry eye) Grade 1: one fold above the normal tear meniscus height- mild dry eye Grade 2: multiple folds up to the height of normal tear meniscus- moderately dry eye Grade 3: multiple folds above normal tear meniscus height- severe dry eye Authors claim that LIPCOF has 93% positive predictive value. In other words, it detects dry eye with 93% certainty. Its negative predictive value is claimed to be 76%. Furthermore, LIPCOF is not invasive, takes very short time to perform and has no additional costs, as it requires use of no test strips, dyes etc.
Despite all mentioned advantages of this method, we still do not know what it actually measures- proven correlation between conjunctival folds and other signs and symptoms of dry eye does not automatically point at the reasons of their appearance.
One of the possible causes of LIPCOF may be decreased lubrication and increased friction of ocular surface and eyelids during blinking in dysfunctional tear syndrome. The importance of friction between the upper eyelid and ocular surface was well described by Korb in his Lid Wiper Epitheliopathy concept.
Nowadays, we have at our disposal commercially available rewetting eyedrops which, due to their formulation, display proven lubricating effect as well. If their application reduces LIPCOF grade, then increased friction may be the cause of the appearance of folds. Furthermore, such finding may show that this sign of dysfunctional tear syndrome may be influenced by appropriate therapy.
The aim of this study was to try to establish whether LIPCOF can be influenced by increased lubrication with rewetting and lubricating eyedrops containing hydroxypropyl-guar which has proven lubricating effect. Should that be the case, then it may be concluded that conjunctival folds appear due to the increased friction, and that they are dynamic condition, reversible after appropriate therapy. The influence of lubrication on other signs and symptoms of dry eye was also observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lubricating eyedrops containing HP-guar | Experimental | Drug: Lubricating eyedrops containing hydroxypropyl-guar |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ocular foreign body sensation, burning or stinging, complaints more pronounced in winter, windy conditions, during computer work, being bilateral, of the duration longer than three months, visual acuity fluctuations depending on blinking after longer reading or computer work, and tearing in cold weather, in the morning, after longer reading or computer work. Patients were also asked whether the symptoms were more pronounced in the morning or evening. The main enrollment criterion was the score of the above listed symptoms 15 or higher.
Key exclusion criteria (1 listed)
- Pregnant women, children, chronic eye patients on continuous topical therapy during previous month (i.e.glaucoma) and patients suffering from any acute eye disease and therefore on topical or systemic therapy in the previous month were excluded from the study.
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 |
|---|---|---|
| Lubricating eyedrops containing hydroxypropyl-guarAlso: Systane lubricating eyedrops, ALCONEyedrops BID | Drug | Lubricating eyedrops containing HP-guar |
Primary outcome
Lid-parallel conjunctival folds (LIPCOF)
Time frame: 14 days
The effect of topical therapy with lubricating eyedrops on lid-parallel conjunctival folds (LIPCOF).
1 secondary outcome
Signs and symptoms of dry eye
Time frame: 14 days
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 31 Dec 2010.
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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.
Igor Petricek, MD principal investigator
Zagreb University Hospital Eye Department
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 Lubricating eyedrops containing hydroxypropyl-guar in people with Dry Eye Syndromes, run by University of Zagreb at 1 site in Croatia.
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 1 inclusion and 1 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 31 Dec 2010. 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 Croatia. 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?
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?
Lid-parallel conjunctival folds (LIPCOF) (time frame: 14 days). 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 31 Dec 2010; AzTrials last refreshed its copy on 7 Nov 2026.