A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients With Moderate to Severe Conjunctivochalasis

Ocuwize LTD3 sites in 1 country62 target enrollmentJuly 2016

ConditionsConjunctivochalasis

InterventionsLO2A Saline

DrugsLO2A Saline

Overview

Phase: Phase 2
Intervention: LO2A
Conditions: Conjunctivochalasis
Sponsor: Ocuwize LTD
Enrollment: 62
Locations: 3
Primary Endpoint: The change from baseline in lissamine green conjunctival staining (LGCS) score.
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients with Moderate to Severe Conjunctivochalasis

Detailed Description

Phase 2, randomized, placebo-controlled, parallel group, study in up to 62 adult patients with moderate to severe CCh. Eligible patients will be randomly assigned in a 1:1 ratio to one of two treatment groups, LO2A or placebo, stratified by LIPCOF grade at baseline. This study with 4 visits, will consist of a screening period of up to 2 weeks and a 3-month treatment period (topical, OU, QID application of eye drops).

Registry

clinicaltrials.gov

Start Date

July 2016

End Date

June 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ocuwize LTD

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female of any race and ≥ 18 years of age.
•Willing and able to provide voluntary written informed consent.
•Moderate to severe conjunctivochalasis defined by:
•LIPCOF score ≥ 2; and
•Lissamine green conjunctival staining score ≥ 5 according to National Eye Institute/Industry Workshop report.
•Willing and able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria

•Subject has concurrent, uncontrolled medical condition, or psychiatric illness which could place him/her at unacceptable risk, including, but not limited to:
•Subject has been diagnosed or treated for another malignancy within 3 years of screening, except in situ malignancy, or low-risk prostate, skin or cervix cancer after curative therapy.
•A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications.
•Subjects with pterygium.
•Subjects with active, allergic keratoconjunctivitis, or conjunctivitis of infectious origin.
•Subjects with blepharitis requiring treatment.
•Subjects with a history of surgery affecting the eye surface, as well as eye injuries within 3 months of screening.
•Subjects currently using any topical ophthalmic treatment (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial.
•Subjects who have used any of the following medications or treatments:
•LASIK or PRK surgery within 12 months of Visit

Arms & Interventions

LO2A

Sodium Hyaluronate

Intervention: LO2A

Placebo-Controlled

Saline.

Intervention: Saline

Outcomes

Primary Outcomes

The change from baseline in lissamine green conjunctival staining (LGCS) score.

Time Frame: 3 Months

Secondary Outcomes

The change in the lid-parallel conjunctival fold (LIPCOF) grade score at 1 and 3 months compared to baseline(3 Months)
The change from baseline in LGCS score(1 month)
The change in tear-film break up time (TFBUT) compared to baseline at 1 and 3 months(3 Months)
The change in ocular surface disease index (OSDI) questionnaire score compared to baseline at 1 and 3 months(3 Months)