The Effect of Ocular Lubricant Eyedrops on Lid Parallel Conjunctival Folds and Other Signs and Symptoms of Dry Eye (LIPCOF)
|ClinicalTrials.gov Identifier: NCT01268735|
Recruitment Status : Completed
First Posted : December 31, 2010
Last Update Posted : December 31, 2010
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 or disease||Intervention/treatment||Phase|
|Dry Eye Syndromes||Drug: Lubricating eyedrops containing hydroxypropyl-guar||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||229 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Ocular Surface Lubricant Eyedrops on Lid Parallel Conjunctival Folds (LIPCOF) and Other Signs and Symptoms of Dysfunctional Tear Syndrome|
|Study Start Date :||April 2009|
|Primary Completion Date :||September 2009|
|Study Completion Date :||February 2010|
|Experimental: Lubricating eyedrops containing HP-guar||
Drug: Lubricating eyedrops containing hydroxypropyl-guar
Other Name: Systane lubricating eyedrops, ALCON
- Lid-parallel conjunctival folds (LIPCOF) [ Time Frame: 14 days ]The effect of topical therapy with lubricating eyedrops on lid-parallel conjunctival folds (LIPCOF).
- Signs and symptoms of dry eye [ Time Frame: 14 days ]The effect of topical therapy with lubricating eyedrops on the signs and symptoms of dry eye.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01268735
|Zagreb University Hospital Eye Department|
|Zagreb, Croatia, HR-10000|
|Principal Investigator:||Igor Petricek, MD||Zagreb University Hospital Eye Department|