NCT00825721

Brief Summary

This study will evaluate the safety and efficacy of three doses of C-KAD Ophthalmic Solution in patients with loss of visual function due to age-related nuclear cataract

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
81

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2007

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

November 1, 2007

Completed
1.2 years 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
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

January 21, 2009

Status Verified

January 1, 2009

Enrollment Period

1.8 years

First QC Date

January 19, 2009

Last Update Submit

January 20, 2009

Conditions

Nuclear Cataract

Keywords

Cataract StudyOphthalmic StudyAgerelated cataractNuclear CataractLow grade nuclear cataracts

Outcome Measures

Primary Outcomes (1)

  • Best-corrected visual acuity by ETDRS

    360 days

Study Arms (4)

1.3% (low dose)

ACTIVE COMPARATOR
Drug: C-KAD Ophthalmic Solution

2% (medium dose)

ACTIVE COMPARATOR
Drug: C-KAD Ophthalmic Solution

2.6% (high dose)

ACTIVE COMPARATOR
Drug: C-KAD Ophthalmic Solution

Placebo

PLACEBO COMPARATOR
Drug: LiquiTears

Interventions

LiquiTearsDRUG

4 drops applied daily for 360 days

Placebo
C-KAD Ophthalmic SolutionDRUG

4 drops applied daily for 360 days

1.3% (low dose)

Eligibility Criteria

Age35 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of nuclear sclerosis cataract
  • BCDVA within the range of 20/40 and 20/80

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 (1)

Tilganga Eye Center

Kathmandu, Kathmandu, Nepal

Location

Study Officials

  • Sanduk Ruit, MD

    Tilganga Eye Center

    PRINCIPAL INVESTIGATOR

  • Reeta Gurung, MD

    Tilganga Eye Center

    PRINCIPAL INVESTIGATOR

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

January 19, 2009

First Posted

January 21, 2009

Study Start

November 1, 2007

Primary Completion

August 1, 2009

Study Completion

September 1, 2009

Last Updated

January 21, 2009

Record last verified: 2009-01

Locations

NE(1)