NCT00825942

Brief Summary

To determine the safety and initial efficacy of C-KAD ophthalmic solution in patients with asteroid hyalosis

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 21, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

April 17, 2009

Status Verified

April 1, 2009

Enrollment Period

1.3 years

First QC Date

January 19, 2009

Last Update Submit

April 16, 2009

Conditions

Asteroid Hyalosis

Keywords

Asteroid hyalosisOpthalmic Study

Outcome Measures

Primary Outcomes (1)

  • Reduction in the number of asteroid bodies

    180

Study Arms (1)

C-KAD Ophthalmic Solution

EXPERIMENTAL
Drug: C-KAD Ophthalmic Solution

Interventions

C-KAD Ophthalmic SolutionDRUG

4 drops applied daily for 180 days

C-KAD Ophthalmic Solution

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of asteroid hyalosis

You may not qualify if:

  • Active ocular infection
  • Glaucoma
  • Ocular hypertension
  • Ocular inflammatory disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mountain View Optometry and Contact Lens Clinic

Mountain View, California, 94041, United States

Location

Study Officials

  • Ira Wong, MD

    Chakshu Research, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 19, 2009

First Posted

January 21, 2009

Study Start

July 1, 2008

Primary Completion

October 1, 2009

Study Completion

November 1, 2009

Last Updated

April 17, 2009

Record last verified: 2009-04

Locations

US(1)