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

NCT01268735 | Completed Phase 4

• 1 other identifier: LIPCOF Petricek
• Study Type: interventional
• Target: 229
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dry Eye Syndromes

Keywords

Dysfunctional Tear Syndrome; Dry Eye; LIPCOF; Hydroxypropyl-guar

Outcome Measures

Primary Outcomes (1)

• Lid-parallel conjunctival folds (LIPCOF)

  The effect of topical therapy with lubricating eyedrops on lid-parallel conjunctival folds (LIPCOF).

  14 days

Secondary Outcomes (1)

• Signs and symptoms of dry eye

  14 days

Study Arms (1)

Lubricating eyedrops containing HP-guar

EXPERIMENTAL

Drug: Lubricating eyedrops containing hydroxypropyl-guar

Interventions

Lubricating eyedrops containing hydroxypropyl-guar DRUG

Eyedrops BID

Also known as: Systane lubricating eyedrops, ALCON

Lubricating eyedrops containing HP-guar

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Zagreb: lead

Study Sites (1)

Zagreb University Hospital Eye Department

Zagreb, HR-10000, Croatia

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Igor Petricek, MD

  Zagreb University Hospital Eye Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 30, 2010
• First Posted: December 31, 2010
• Study Start: April 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: February 1, 2010
• Last Updated: December 31, 2010

Record last verified: 2010-12

Locations

CR (1)