The Effect of Ocular Lubricant Eyedrops on Lid Parallel Conjunctival Folds and Other Signs and Symptoms of Dry Eye (LIPCOF)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Dry Eye Syndromes |
Drug: Lubricating eyedrops containing hydroxypropyl-guar |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Effect of Ocular Surface Lubricant Eyedrops on Lid Parallel Conjunctival Folds (LIPCOF) and Other Signs and Symptoms of Dysfunctional Tear Syndrome |
- Lid-parallel conjunctival folds (LIPCOF) [ Time Frame: 14 days ] [ Designated as safety issue: No ]The effect of topical therapy with lubricating eyedrops on lid-parallel conjunctival folds (LIPCOF).
- Signs and symptoms of dry eye [ Time Frame: 14 days ] [ Designated as safety issue: No ]The effect of topical therapy with lubricating eyedrops on the signs and symptoms of dry eye.
| Enrollment: | 229 |
| Study Start Date: | April 2009 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Lubricating eyedrops containing HP-guar |
Drug: Lubricating eyedrops containing hydroxypropyl-guar
Eyedrops BID
Other Name: Systane lubricating eyedrops, ALCON
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Contacts and Locations| Croatia | |
| Zagreb University Hospital Eye Department | |
| Zagreb, Croatia, HR-10000 | |
| Principal Investigator: | Igor Petricek, MD | Zagreb University Hospital Eye Department |
More Information
No publications provided
| Responsible Party: | Igor Petricek, Ophthalmologist, Zagreb University Hospital Eye Department |
| ClinicalTrials.gov Identifier: | NCT01268735 History of Changes |
| Other Study ID Numbers: | LIPCOF Petricek |
| Study First Received: | December 30, 2010 |
| Last Updated: | December 30, 2010 |
| Health Authority: | Croatia: Ethics Committee |
Keywords provided by University of Zagreb:
|
Dysfunctional Tear Syndrome Dry Eye LIPCOF Hydroxypropyl-guar |
Additional relevant MeSH terms:
|
Dry Eye Syndromes Keratoconjunctivitis Sicca Signs and Symptoms Lacrimal Apparatus Diseases Eye Diseases Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Keratitis Corneal Diseases Tetrahydrozoline |
Nasal Decongestants Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Respiratory System Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013