Clinical trial NCT02804191: Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients With Moderate to Severe Conjunctivochalasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Conjunctivochalasis
Lead sponsor: Ocuwize LTD
Sponsor class: INDUSTRY
First posted: 2016-06-17
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: The change from baseline in lissamine green conjunctival staining (LGCS) score.
timeFrame: 3 Months
Secondary outcomes:
measure: The change in the lid-parallel conjunctival fold (LIPCOF) grade score at 1 and 3 months compared to baseline
timeFrame: 3 Months
measure: The change from baseline in LGCS score
timeFrame: 1 month
measure: The change in tear-film break up time (TFBUT) compared to baseline at 1 and 3 months
timeFrame: 3 Months
measure: The change in ocular surface disease index (OSDI) questionnaire score compared to baseline at 1 and 3 months
timeFrame: 3 Months
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam
city: Jerusalem
country: Israel
facility: Hadassah
city: Tel Aviv
country: Israel
facility: Ichilov Tel Aviv hospital
Study officials:
affiliation: Ocuwize Pharma
name: Or Eisenberg, CPA
role: STUDY_DIRECTOR
References: