An Evaluation of Use of Topical Ocular Hypotensive Medica... | NCT00329095

Studies
An Evaluation of Use of Topical Ocular Hypotensive Medication by Compliance

NCT00329095

Sponsor

Robin, Alan L., M.D.

Status

Completed

Last Update Posted

May 24, 2006Estimated

Enrollment

Phase

Phase 4

Conditions

Glaucoma
Ocular Hypertension

Interventions

travoprost, latanoprost, or bimatoprost
Additional ocular hypotensive medication

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2005

Primary Completion Date

Not provided

Completion Date

Apr 2006

First Submitted Date

May 19, 2006

First Submission Date that Met QC Criteria

May 22, 2006

First Posted Date

May 24, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2006

Last Update Posted Date

May 24, 2006Estimated

Description Module

Brief Summary

This is an open-label study in patients who are currently using either a topical prostaglandin as sole ocular hypotensive medical therapy q.d., or a topical prostaglandin plus an adjunctive topical ocular hypotensive marketed product either q.d., or b.i.d. in the same eye(s). Compliance will be measured over the two months of participation.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Measure	Description	Time Frame
Compliance.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Currently using one or two topical ocular hypotensive medications

Exclusion Criteria:

Hypersensitivity to any component of medication

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Alan L. Robin, MD	Alan L. Robin, M.D.	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17686450	Derived	Robin AL, Novack GD, Covert DW, Crockett RS, Marcic TS. Adherence in glaucoma: objective measurements of once-daily and adjunctive medication use. Am J Ophthalmol. 2007 Oct;144(4):533-40. doi: 10.1016/j.ajo.2007.06.012. Epub 2007 Aug 8.

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D010349	Patient Compliance

ID	Term
D005128	Eye Diseases
D010342	Patient Acceptance of Health Care
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior

ID	Term
D000069557	Travoprost
D000077338	Latanoprost
D000069580	Bimatoprost

ID	Term
D003008	Cloprostenol
D011461	Prostaglandins F, Synthetic
D011465	Prostaglandins, Synthetic
D011453	Prostaglandins

Name	Type	Description	Arm Group Labels	Other Names
travoprost, latanoprost, or bimatoprost	Drug
Additional ocular hypotensive medication	Drug