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Comparison of Tolerability and Clinical Performance of Two Emulsion-type Artificial Tears

Comparison of Tolerability and Clinical Performance of Two Emulsion-type Artificial Tears

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01335126
Enrollment
48
Registered
2011-04-14
Start date
2011-03-31
Completion date
2011-11-30
Last updated
2011-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye

Keywords

Artificial tears

Brief summary

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

Interventions

OTHEREmulsion type artificial tear

2 types of artificial tears

Sponsors

Allergan
CollaboratorINDUSTRY
Hom, Milton M., OD, FAAO
Lead SponsorINDIV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Tolerability Questionnaire8 weeksTolerability (comfort) measured with Visual Analog scale (1 to 100)

Secondary

MeasureTime frameDescription
Acceptability Questionnaire8 weeksAcceptability questionnaire on statements regarding drop satisfaction, etc. Answered as A to E (Strongly Agree, Agree, Neither Agree or Disagree, Disagree or Strongly Disagree)
Tear Break Up Time2-3 weeksTear Break Up Time measured in seconds

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026