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Acute Comfort of Lubricant Eye Drop FID 111421

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00673959
Enrollment
20
Registered
2008-05-07
Start date
2007-12-31
Completion date
Unknown
Last updated
2012-02-02

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

Conditions

Dry Eye

Keywords

Dry eye, artificial tears

Brief summary

To evaluate the acute comfort and blurring profile between two artificial tears products in dry eye patients

Interventions

OTHEROptive Lubricant Eye Drop

Optive Lubricant Eye Drop 1 drop each eye one time

OTHERLubricant Eye Drop FID 111421

Lubricant Eye Drop FID 111421 1 drop each eye one time

Sponsors

Alcon Research
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

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

Inclusion criteria

* Documented diagnosis of dry eye * Must not have worn contact lenses for 1 week preceding enrollment

Exclusion criteria

* Age related

Design outcomes

Primary

MeasureTime frameDescription
Drop Comfort Upon Instillationupon instillationDrop comfort grading scale is a scale from 0 to 9, with 0 meaning most comfortable and 9 meaning most uncomfortable.

Participant flow

Recruitment details

20 Dry Eye Subjects

Pre-assignment details

Randomized, double-masked, crossover

Participants by arm

ArmCount
Overall Study20
Total20

Baseline characteristics

CharacteristicOverall Study
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
3 Participants
Age, Categorical
Between 18 and 65 years
17 Participants
Sex: Female, Male
Female
16 Participants
Sex: Female, Male
Male
4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 200 / 20
serious
Total, serious adverse events
0 / 200 / 20

Outcome results

Primary

Drop Comfort Upon Instillation

Drop comfort grading scale is a scale from 0 to 9, with 0 meaning most comfortable and 9 meaning most uncomfortable.

Time frame: upon instillation

ArmMeasureValue (MEAN)Dispersion
Lubricant Eye Drop FID 111421Drop Comfort Upon Instillation1.7 Units on a scaleStandard Deviation 1.8
Optive Lubricant Eye DropDrop Comfort Upon Instillation1.3 Units on a scaleStandard Deviation 1.4

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