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CompletedNCT02810119Updated Oct 27, 2017

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

A Phase 2 interventional study of LO2A and Placebo in Conjunctivochalasis, sponsored by Ocuwize LTD. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-27.

Sponsored by Ocuwize LTD · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
13
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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).

02

Conditions studied

  • Conjunctivochalasis
03

In context

Lead sponsor

Ocuwize LTD is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    LO2A

    Sodium Hyaluronate

    Drug: LO2A

  • Placebo comparator
    Placebo-Controlled Saline

    Placebo

    Drug: Placebo

Interventions

  • DrugLO2A
  • DrugPlacebo
06

What researchers measure

Primary outcomes

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

    Time frame: baseline and 3 months

Secondary outcomes

  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

07

Study locations

1 site
  • Barzilai MC
    Ashkelon, Israel
08

References and documents

Individual participant data

Plan to share: Undecided — Final Data report will be publish when the study will be finalized

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02810119
Lead sponsor
Ocuwize LTD
Responsible party
Sponsor
First posted
Jun 22, 2016
Start date
Nov 2016
Primary completion
Oct 2017
Completion
Oct 2017
Last update
Oct 27, 2017
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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