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Dose-Ranging Study of an Ophthalamic Solution in Patients With Loss of Visual Function Due to Age-Related Nuclear Cataract

Primary Purpose

Nuclear Cataract

Status

Unknown status

Phase

Phase 2

Locations

Nepal

Study Type

Interventional

Intervention

LiquiTears

C-KAD Ophthalmic Solution

About this trial

This is an interventional treatment trial for Nuclear Cataract focused on measuring Cataract Study, Ophthalmic Study, Agerelated cataract, Nuclear Cataract, Low grade nuclear cataracts

Eligibility Criteria

35 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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

Sites / Locations

Tilganga Eye Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1.3% (low dose)

2% (medium dose)

2.6% (high dose)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Best-corrected visual acuity by ETDRS

Secondary Outcome Measures

Full Information

NCT ID

NCT00825721

First Posted

January 19, 2009

Last Updated

January 20, 2009

Sponsor

Chakshu Research, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00825721

Brief Title

Dose-Ranging Study of an Ophthalamic Solution in Patients With Loss of Visual Function Due to Age-Related Nuclear Cataract

Official Title

A Randomized, Placebo-Controlled, Single-Masked, Dose-Ranging Study of C-KAD Ophthalmic Solution in Patients With Loss of Visual Function Due to Age-Related Nuclear Cataracts

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Unknown status

Study Start Date

November 2007 (undefined)

Primary Completion Date

August 2009 (Anticipated)

Study Completion Date

September 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Chakshu Research, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nuclear Cataract

Keywords

Cataract Study, Ophthalmic Study, Agerelated cataract, Nuclear Cataract, Low grade nuclear cataracts

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

81 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1.3% (low dose)

Arm Type

Active Comparator

Arm Title

2% (medium dose)

Arm Type

Active Comparator

Arm Title

2.6% (high dose)

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

LiquiTears

Intervention Description

4 drops applied daily for 360 days

Intervention Type

Drug

Intervention Name(s)

C-KAD Ophthalmic Solution

Intervention Description

4 drops applied daily for 360 days

Intervention Type

Drug

Intervention Name(s)

C-KAD Ophthalmic Solution

Intervention Description

4 drops applied daily for 360 days

Intervention Type

Drug

Intervention Name(s)

C-KAD Ophthalmic Solution

Intervention Description

4 drops applied daily for 360 days

Primary Outcome Measure Information:

Title

Best-corrected visual acuity by ETDRS

Time Frame

360 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Presence of nuclear sclerosis cataract BCDVA within the range of 20/40 and 20/80 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sanduk Ruit, MD

Organizational Affiliation

Tilganga Eye Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Reeta Gurung, MD

Organizational Affiliation

Tilganga Eye Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tilganga Eye Center

City

Kathmandu

Country

Nepal

12. IPD Sharing Statement

Learn more about this trial

Dose-Ranging Study of an Ophthalamic Solution in Patients With Loss of Visual Function Due to Age-Related Nuclear Cataract

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