Safety and Efficacy Study of an Ophthalmic Solution in Patients With Age-Related Cataract
Sponsor
Chakshu Research, Inc. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT00793091
Collaborator
(none)
80
4
2
10
20
2
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the safety and efficacy of C-KAD Ophthalmic Solution in improving visual acuity relative to placebo in patients with age-related cataract
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Randomized, Placebo-Controlled, Double-Masked, Multicenter Safety and Efficacy Study of C-KAD Ophthalmic Solution in Patients With Loss of Visual Acuity Due to Age-Related Cataract
Study Start Date
:
Nov 1, 2008
Anticipated Primary Completion Date
:
Aug 1, 2009
Anticipated Study Completion Date
:
Sep 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 1
|
Drug: C-KAD Ophthalmic Solution
4 drops applied daily for 120 days
|
| Placebo Comparator: 2
|
Drug: Placebo
4 drops applied daily for 120 days
|
Outcome Measures
Primary Outcome Measures
- Best-corrected visual acuity by ETDRS [120 Days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Presence of age-related cataract in the study eye
-
Best-corrected visual acuity of 20/25 to 20/50 in the study eye
Exclusion Criteria:
-
Any other clinical condition in the eye that may compromise vision
-
Presence or History of Glaucoma
-
Presence or history of diabetes
-
Use of eyedrops
-
Use of steroids
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pacific Eye Specialists | San Francisco | California | United States | 94115 |
| 2 | Hunkeler Eye Institute | Overland Park | Kansas | United States | 66210 |
| 3 | Minnesota Eye Consultants, PA | Minneapolis | Minnesota | United States | 55405 |
| 4 | Charlotte Eye, Ear, Nose & Throat Associates | Charlotte | North Carolina | United States | 28210 |
Sponsors and Collaborators
- Chakshu Research, Inc.
Investigators
- Study Director: Ira Wong, MD, Chakshu Research, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00793091
Other Study ID Numbers:
- CK-0109
First Posted:
Nov 19, 2008
Last Update Posted:
Nov 27, 2008
Last Verified:
Nov 1, 2008