Phase 2 Study of KLS-0611 in Patients With Dry Eye Syndromes

A Randomized, Double Blind, Placebo Controlled, Phase 2 Study of KLS-0611 in Patients With Dry Eye Syndromes

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00721656

Enrollment

Registered

2008-07-24

Start date

Unknown

Completion date

Unknown

Last updated

2009-03-18

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

Conditions

Dry Eye Syndromes

Keywords

Dry eye syndromes, Corneal diseases, Conjunctival Diseases

Brief summary

To evaluate the efficacy and safety of KLS-0611 compared to placebo in patients with dry eye syndromes.

Interventions

DRUGPlacebo

DRUGKLS-0611

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Corneal and conjunctival damage * Insufficiency of lacrimal secretion * Ocular symptom

Exclusion criteria

* Severe ophthalmic disorder * Punctual plugs or surgery for occlusion of the lacrimal puncta

Design outcomes

Primary

Measure	Time frame
Corneal-conjunctival staining	4 weeks

Countries

Japan

Outcome results

None listed

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