Tear Film Break-up Time After Instillation of Artificial Tears

Status Completed

Clinical Trial Summary

This study is an exploratory trial evaluating the tear film break-up time after a single eye drop instillation of over-the-counter artificial tears. The primary hypothesis is that tear film break up time will be greater for test than control eye.

Clinical Trial Description

Subjects with varying degrees of dry eye syndrome were enrolled in a randomized, controlled, double masked, single site study. A new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient was compared against a leading commercial product with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent. The primary outcome was a comparison of tear film stability after eye drop instillation. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00681265
Study type	Interventional
Source	Eyeon Therapeutics, Inc.
Contact
Status	Completed
Phase	N/A
Start date	June 2008
Completion date	August 2008

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05618730` - Safety, Tolerability, Plug Retention and Preliminary Efficacy of Tacrolimus-loaded Punctal Plug in Patients With Moderate to Severe Dry Eye Disease - Cohort B	Phase 1
Completed	`NCT02254265` - Phase 2/3 Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca	Phase 2/Phase 3
Completed	`NCT00883649` - Efficacy and Safety Study of Nutritional Supplements for Treatments of Dry Eye	N/A
Completed	`NCT00717418` - Efficacy Study of Cyclosporine Ophthalmic Emulsion in Patients With Dry Eye Disease	N/A
Completed	`NCT00128245` - Safety and Efficacy of Pimecrolimus Ophthalmic Suspension in Patients With Moderate to Severe Keratoconjunctivitis Sicca	Phase 2
Enrolling by invitation	`NCT03436576` - Efficacy of Two Concentrations of Autologous Serum for the Treatment of Severe Dry Eye	Phase 3
Completed	`NCT04147650` - Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome	Phase 2/Phase 3
Completed	`NCT01733992` - A Safety, Tolerability and Pharmacokinetics Study of R932348 Eye Drops in Patients With Dry Eye Disease	Phase 1
Completed	`NCT00987727` - Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye	Phase 4
Completed	`NCT00788229` - Efficacy and Safety Study of ATs in Patients With Dry Eye Syndrome	Phase 2
Completed	`NCT00554879` - Acupuncture Treatment of Dry Eye	N/A
Completed	`NCT00407043` - Multicenter, Randomized, Controlled Study of the Effect of Lotemax on Initiation of Dry Eye Treatment With Restasis	Phase 4
Completed	`NCT00001731` - Treatment of Dry Eye Syndrome With Cyclosporin A Eye Drops	Phase 2
Recruiting	`NCT03953703` - Levocarnitine for Dry Eye in Sjogren's Syndrome	Phase 2
Withdrawn	`NCT03398018` - Repository Corticotropin Injection in Keratoconjunctivitis Sicca	Phase 4
Recruiting	`NCT02066896` - Laser Therapy to Treat the Dry Mouth of Sjogren's Syndrome	Phase 3
Completed	`NCT02139033` - A Phase 4 Study Investigating the Efficacy of Retaine™ in Managing Signs and Symptoms Associated With Dry Eye Syndrome	Phase 4
Terminated	`NCT01213342` - Omega-3 Fatty Acid Supplements and Dry Eye	N/A
Completed	`NCT00201981` - Study of Rebamipide Eye Drops to Treat Dry Eye	Phase 3
Completed	`NCT00201955` - Study of Rebamipide Eye Drops to Treat Dry Eye	Phase 3