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To Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients With Conjunctivochalasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02810119
Recruitment Status : Completed
First Posted : June 22, 2016
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
Ocuwize LTD

Brief Summary:
A Randomized, Double-Blind, Placebo-Controlled, Pilot Study to Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients with Moderate to Severe Conjunctivochalasis

Condition or disease Intervention/treatment Phase
Conjunctivochalasis Drug: LO2A Drug: Placebo Phase 2

Detailed Description:

Phase 2a, randomized, placebo-controlled, pilot study in up to 21 adult patients with moderate to severe CCh. Eligible patients will be randomly assigned in a 2:1 (active:placebo) ratio to one of two treatment groups, LO2A or placebo.

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Pilot Study to Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients With Moderate to Severe Conjunctivochalasis
Actual Study Start Date : November 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Arm Intervention/treatment
Experimental: LO2A
Sodium Hyaluronate
Drug: LO2A
Placebo Comparator: Placebo-Controlled Saline
Placebo
Drug: Placebo



Primary Outcome Measures :
  1. The change from baseline in lissamine green conjunctival staining (LGCS) score [ Time Frame: baseline and 3 months ]

Secondary Outcome Measures :
  1. The change in the lid-parallel conjunctival fold (LIPCOF) grade score at 1 and 3 months compared to baseline [ Time Frame: baseline, 1 month and 3 months ]
  2. The change from baseline in LGCS score [ Time Frame: baseline and 1 month ]
  3. The change in tear-film break up time (TFBUT) compared to baseline at 1 and 3 months [ Time Frame: baseline, 1 month and 3 months] ]
  4. The change in ocular surface disease index (OSDI) questionnaire score compared to baseline at 1 and 3 months [ Time Frame: baseline, 1 month and 3 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female of any race and ≥ 18 years of age.
  2. Willing and able to provide voluntary written informed consent.
  3. Moderate to severe conjunctivochalasis defined by:

    • LIPCOF score ≥ 2; and
    • Lissamine green conjunctival staining score ≥ 5 according to National Eye Institute/Industry Workshop report.
  4. Willing and able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

  1. 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.
  2. Subjects with pterygium.
  3. Subjects with active, allergic keratoconjunctivitis, or conjunctivitis of infectious origin.
  4. Subjects with blepharitis requiring treatment.
  5. Subjects with a history of surgery affecting the eye surface, as well as eye injuries within 3 months of screening.
  6. 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.
  7. Subjects who have used any of the following medications or treatments:

    • LASIK or PRK surgery within 12 months of Visit 1.
    • Use of contact lenses within 7 days of Visit 1.
    • Punctal plug insertion within 30 days of Visit 1.
    • Use of topical or systemic cyclosporine within 30 days of Visit 1.
    • Use of medications known to cause ocular drying (e.g. antihistamines, sleep aids, etc.), unless at a stable dose, within 30 days of Visit 1.
  8. Known hypersensitivity to sodium hyaluronate or any LO2A excipients (glycerol and Carbomer 981).
  9. Active abuse of alcohol or drugs.
  10. Any condition, which in the opinion of the Investigator, would place the patient at an unacceptable risk if participating in the study protocol.
  11. Participation in a clinical trial of an investigational (unapproved) drug or device within 1 month prior to screening or scheduled to receive another investigational drug or device during this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810119


Locations
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Israel
Barzilai MC
Ashkelon, Israel
Sponsors and Collaborators
Ocuwize LTD
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Responsible Party: Ocuwize LTD
ClinicalTrials.gov Identifier: NCT02810119    
Other Study ID Numbers: WP-LO2A-02
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Final Data report will be publish when the study will be finalized