The Effect of Ocular Lubricant Eyedrops on Lid Parallel Conjunctival Folds and Other Signs and Symptoms of Dry Eye (LIPCOF)

This study has been completed.
Sponsor:
Information provided by:
University of Zagreb
ClinicalTrials.gov Identifier:
NCT01268735
First received: December 30, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by University of Zagreb:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01268735

Locations
Croatia
Zagreb University Hospital Eye Department
Zagreb, Croatia, HR-10000
Sponsors and Collaborators
University of Zagreb
Investigators
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 July 20, 2014