NCT00825396

Brief Summary

The purpose of this study is to determine the safety and tolerability of topical C-KAD Ophthalmic Solution in reducing intraocular pressure in patients with ocular hypertension.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 21, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

June 11, 2009

Status Verified

June 1, 2009

Enrollment Period

2 years

First QC Date

January 16, 2009

Last Update Submit

June 9, 2009

Conditions

Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Mean change in intraocular pressure from baseline

    150 Days

Study Arms (1)

C-KAD Ophthalmic Solution

EXPERIMENTAL
Drug: C-KAD Ophthalmic Solution

Interventions

C-KAD Ophthalmic SolutionDRUG

4 drops applied daily for 150 days

C-KAD Ophthalmic Solution

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both eyes having intraocular pressure in the range of 22-30 mmHg at baseline
  • Both eyes having best corrected visual acuity better than 20/50

You may not qualify if:

  • Advanced glaucoma
  • Closed or barely open anterior chamber or history of angle closure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charlotte Eye, Ear, Nose & Throat Associates

Charlotte, North Carolina, 28210, United States

Location

MeSH Terms

Conditions

Ocular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Ira Wong, MD

    Chakshu Research, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 16, 2009

First Posted

January 21, 2009

Study Start

April 1, 2007

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

June 11, 2009

Record last verified: 2009-06

Locations

US(1)