NCT01335126

UnknownPhase 3

Comparison of Tolerability and Clinical Performance of Two E...

Hom, Milton M., OD, FAAO Source

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Other study identifiers

Sponsor study identifier

AG9965-007

Study Type

interventional

Estimated enrollment

48

Locations

0 countries

Sites

N/A

Timeline

Study Start

March 2011

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

October 2011

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

November 2011

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief Summary

The purpose of this study is to evaluate the performance between two emulsion-type artificial tears.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 48 participants
Study completion date: November 2011
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 2011
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
April 12, 2011
Actual (reported)
First Posted
April 14, 2011
Actual (reported)
Primary Completion
October 2011
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2011
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: April 14, 2011
Status Verified: April 2011
Last Update Submitted: April 13, 2011

Conditions

Dry Eye

Keywords

Artificial tears

Outcome Measures

Primary Outcomes (1)

Tolerability Questionnaire
Tolerability (comfort) measured with Visual Analog scale (1 to 100)
8 weeks

Secondary Outcomes (2)

Acceptability Questionnaire
8 weeks
Tear Break Up Time
2-3 weeks

Study Arms (1)

Test

EXPERIMENTAL

Other: Emulsion type artificial tear

Interventions

Emulsion type artificial tearOther

2 types of artificial tears

Test

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Between the ages of 18 and over inclusive.
Males or females

Sponsors & Collaborators

Hom, Milton M., OD, FAAO
Individuallead
Allergan
Industrycollaborator

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

Milton M Hom, OD FAAO
Private Practice
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: INVESTIGATOR
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: INDIV

Study Record Dates

First Submitted

April 12, 2011

First Posted

April 14, 2011

Study Start

March 2011

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

October 2011

Estimated (date passed)

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Phase 3Completed

NCT02405039

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Phase 3Unknown

NCT01227226

Tear Osmolarity Over Time With Artificial Tears

Phase 4Unknown

Patient is in generally good \& stable overall health.

Patient likely to comply with study guidelines \& study visits.

Informed consent signed.

OSDI score \>18 OR

TBUT \<10 seconds

You may not qualify if:

Corneal refractive surgery or contact lens wear within 6 months of this study.
Current use of Restasis
Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
Pregnant or lactating women.
Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.

Contact the study team to confirm eligibility.

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

November 2011

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

April 14, 2011

Record last verified: 2011-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01335126
Data provider: ClinicalTrials.gov
Source updated: 2011-04-14
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:25:53 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Test

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record