An Evaluation of the Safety and Efficacy of FID 114657

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01030237

Enrollment

153

Registered

2009-12-11

Start date

2009-11-30

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

The purpose of this study is to evaluate the safety and efficacy of FID 114657 in comparison to Soothe XP in a specified population of dry eye patients.

Interventions

OTHERFID 114657

1 drop both eyes four times a day for 6 weeks

OTHERSoothe XP Lubricant Eye Drops

1 drop both eyes four times a day for 6 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Documented diagnosis of dry eye * NaFl Corneal Staining sum score ≥ 3 in either eye

Exclusion criteria

* Must not have worn contact lenses for 1 week preceding enrollment

Design outcomes

Primary

Measure	Time frame
Tear Break-Up Time (TBUT)	measured at Days 0, 7, 14, 28 and 42
Corneal Staining	measured at Days 0, 7, 14, 28 and 42
Conjunctival Staining	measured at Days 0, 7, 14, 28 and 42

Outcome results

None listed

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