Safety and Efficacy Study of an Ophthalmic Solution in Patients With Age-Related Cataract
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
1 other identifier
interventional
80
1 country
4
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2008
Shorter than P25 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 17, 2008
CompletedFirst Posted
Study publicly available on registry
November 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedNovember 27, 2008
November 1, 2008
9 months
November 17, 2008
November 26, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Best-corrected visual acuity by ETDRS
120 Days
Study Arms (2)
1
ACTIVE COMPARATOR2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Presence of age-related cataract in the study eye
- Best-corrected visual acuity of 20/25 to 20/50 in the study eye
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Pacific Eye Specialists
San Francisco, California, 94115, United States
Hunkeler Eye Institute
Overland Park, Kansas, 66210, United States
Minnesota Eye Consultants, PA
Minneapolis, Minnesota, 55405, United States
Charlotte Eye, Ear, Nose & Throat Associates
Charlotte, North Carolina, 28210, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ira Wong, MD
Chakshu Research, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 17, 2008
First Posted
November 19, 2008
Study Start
November 1, 2008
Primary Completion
August 1, 2009
Study Completion
September 1, 2009
Last Updated
November 27, 2008
Record last verified: 2008-11