Skip to content

Evaluate Artificial Tear Efficacy in Moderate to Severe Dry Eye

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00724412
Enrollment
279
Registered
2008-07-29
Start date
2008-04-30
Completion date
2009-02-28
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, Corneal Staining

Brief summary

Comparison of two Dry Eye products

Interventions

OTHERSystane

Dry Eye relief eye drops

OTHEROptive

Dry Eye relief eye drops

Sponsors

Alcon Research
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

Inclusion criteria

Inclusion: * Have a score of at least 2 (some of the time) on the subject-assessed Symptom Eligibility question; see Section 8.5.1. * Have a sodium fluorescein corneal staining sum of ≥ 3 in either eye; see Section 8.5.10. * Have a best-corrected visual acuity of 0.6 log MAR or better in each eye as assessed using an ETDRS chart; see Section 8.5.7. Exclusion: * Have a history or current evidence of the following: epithelial herpes simplex keratitis (dendrictic keratitisis); vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva; ocular rosacea; acute or chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye. * Use of Restasis® (cyclosporine ophthalmic emulsion, 0.05%) within 30 days of Visit 1. * Use of systemic medications that may contribute to dry eye if the dosing regimen has not been stable for at least 30 days prior to Visit * Additionally, the dosing regimen must remain stable throughout the study period. Medications known to contribute to dry eye include, but are not limited to, cold and allergy treatments, tricyclic antidepressants, and hormone replacement therapies. * Presence of ocular conditions such as active acute blepharitis, conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of the test article. * Unwilling to discontinue contact lens wear at least 7 days prior to Visit 1 and during the study period. * Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs).

Design outcomes

Primary

MeasureTime frame
Tear Break-up time42 days

Outcome results

None listed

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