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Phase 2/3 Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca

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ClinicalTrials.gov Identifier: NCT02254265
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : November 21, 2016
Sponsor:
Information provided by (Responsible Party):
Ocular Technologies SARL

Brief Summary:
This is a Phase 2/3 study to evaluate the safety and efficacy of 2 different dose concentrations of OTX-101 dosed twice a day in both eyes for 84 days compared to placebo (vehicle) in patients with keratoconjunctivitis sicca (dry eye disease).

Condition or disease Intervention/treatment Phase
Keratoconjunctivitis Sicca Dry Eye Disease Drug: OTX-101 0.05% Drug: OTX-101 0.09% Drug: Vehicle Phase 2 Phase 3

Detailed Description:

Keratoconjunctivitis sicca (KCS) is a common multifactorial ophthalmologic disorder of the tears and ocular surface characterized by symptoms of burning, stinging, itching, grittiness, scratchiness, foreign body sensation, dryness, stickiness and tired eye sensation.

This study is the first clinical safety and efficacy study with OTX-101 and is designed to compare two dose concentrations of OTX-101 against vehicle (placebo) in reducing the signs and symptoms of KCS and evaluate safety when dosed twice a day in both eyes over an 84 day period.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 455 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Double-Masked, Vehicle-Controlled, Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
Study Start Date : September 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: OTX-101 0.05%
OTX-101 0.05% ophthalmic solution 1 drop in both eyes BID for 84 days
Drug: OTX-101 0.05%
OTX-101 0.05% Ophthalmic Solution

Experimental: OTX-101 0.09%
OTX-101 0.09% ophthalmic solution 1 drop in both eyes BID for 84 days
Drug: OTX-101 0.09%
OTX-101 0.09% Ophthalmic Solution

Placebo Comparator: Vehicle
Vehicle of OTX-101 ophthalmic solution 1 drop in both eyes BID for 84 days
Drug: Vehicle
Vehicle of OTX-101 Ophthalmic Solution




Primary Outcome Measures :
  1. Conjunctival staining [ Time Frame: 84 days ]
    Mean change from baseline at day 84 for the lissamine green conjunctival staining score in the designated study eye

  2. Global symptom score [ Time Frame: 84 days ]
    Mean change from baseline at day 84 for the global symptom score


Secondary Outcome Measures :
  1. Tear film break up time (TBUT) [ Time Frame: 84 days ]
    Mean change from baseline in TBUT in the study eye from baseline at Day 84

  2. Clearing of corneal staining [ Time Frame: 84 days ]
    Proportion of subjects with complete clearing of corneal fluorescein staining in the study eye at Day 84

  3. Reduction in conjunctival staining [ Time Frame: 84 days ]
    Proportion o subjects demonstrating a greater than or equal to 30% reduction in lissamine green conjunctival staining in the study eye from baseline to Day 84

  4. Change from baseline [ Time Frame: 56 days ]
    Mean change from baseline at days 14, 28, 42 and 56 for lissamine green conjunctival staining score, global symptom score and TBUT

  5. Schirmers Test [ Time Frame: 84 days ]
    Proportion of subjects demonstrating an increase of greater than or equal to 10 mm in Schirmer's test score from baseline to day 84

  6. Safety and tolerability [ Time Frame: 84 days ]
    Evaluation of incidence of adverse events and assessment of tolerability


Other Outcome Measures:
  1. Patient Satisfaction [ Time Frame: 84 days ]
    Patient satisfaction with treatment score (5 point scale) at days 28, 56 anf 84



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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. Subjects age 18 years or older on the date of informed consent.
  2. All subjects must provide signed written consent prior to participation in any study-related procedures.
  3. Patient-reported history of KCS for a period of at least 6 months.
  4. Clinical diagnosis of bilateral KCS supported by OTX-101-2014-001 study assessments.
  5. Lissamine green conjunctival staining sum score of ≥ 3 to ≤ 9 out of a total possible score of 12 (scoring excludes superior zones 2 and 4) in the same eye at Screening and Baseline.
  6. Global symptom score ≥ 40 at both Screening and Baseline.
  7. Corrected Snellen VA of better than 20/200 in each eye.
  8. Willing to discontinue use of current dry eye therapy (including artificial tears or ocular lubricants) during the study as of the run-in period.
  9. Female subjects of childbearing potential must have a negative urine pregnancy test at Screening. Women of childbearing potential (ie, women who are not either postmenopausal for one year or surgically sterile) must use an acceptable form of contraception throughout the study.

Exclusion Criteria:

  1. Use of cyclosporine ophthalmic emulsion 0.05% (Restasis®) within 3 months prior to Screening.
  2. Previous treatment failure (lack of efficacy) on cyclosporine ophthalmic emulsion 0.05% (Restasis).
  3. Diagnosed with Sjögren's disease ˃5 years prior to Screening.
  4. Clinical diagnosis of seasonal and perennial allergic conjunctivitis.
  5. Use of systemic and topical medications that are known to cause dry eye within 7 days prior to Screening and throughout the study period. These include the following medications:

    • Immunomodulators (permitted if dose is stable for 3 months prior to screening and does not change during the study period)
    • Antihistamines (including over-the counter (OTC))
    • Cholinergics
    • Antimuscarinics
    • Tricyclic antidepressants
    • Phenothiazines
    • Retinoids
  6. Oral omega-3 fatty acids (permitted if dose is stable for 3 months prior to Screening and does not change during the study period)
  7. Use of any topical ophthalmic medications, prescription (including antiglaucoma medications) or OTC (including artificial tears), other than the assigned study medication during the study period.
  8. Current active eye disease other than KCS (i.e., any disease for which topical or systemic ophthalmic medication is necessary).
  9. History of herpes keratitis.
  10. Unstable macular disease (e.g., age-related macular degeneration, diabetic maculopathy). Stable macular disease is defined as no reduction in central VA within 6 months prior to Screening.
  11. Diagnosis of chronic uveitis.
  12. Corneal transplant (e.g., penetrating keratoplasty, lamellar keratoplasty, Descemet's stripping endothelial keratoplasty (DSEK) ).
  13. Corneal refractive surgery (e.g., laser-assisted in situ keratomileusis (LASIK]) photo refractive keratectomy (PRK), limbal relaxing incision (LRI) ) within 6 months prior to screening or postoperative refractive surgery symptoms of dryness that have not resolved.
  14. Cataract surgery within 3 months prior to Screening.
  15. Non-laser glaucoma surgery at any time; glaucoma laser procedures within 3 months prior to Screening.
  16. Presence of punctal plugs or past history of permanent punctal occlusion (e.g., cautery).
  17. Lagophthalmos or clinically significant eyelid margin irregularity of the study eye whether congenital or acquired.
  18. Presence of conjunctivochalasis (i.e., mechanical blockage of the lower lid punctum by redundant conjunctiva).
  19. Presence of pterygium in the study eye.
  20. Unwilling to discontinue use of contact lenses during the duration of the study.
  21. Preplanned elective surgery or hospitalization during the study period.
  22. HIV-positive.
  23. Unable to reliably report symptoms and history.
  24. Has known hypersensitivity or contraindication to the study medication(s) or their components.
  25. Has a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
  26. Has a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up.
  27. Women who are pregnant or breastfeeding.
  28. Participation in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.
  29. Previous randomization into 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): NCT02254265


Locations
United States, Ohio
Cleveland, Ohio, United States
Sponsors and Collaborators
Ocular Technologies SARL
Investigators
Study Director: Tomasz Sablinski, MD PhD Sponsor GmbH

Responsible Party: Ocular Technologies SARL
ClinicalTrials.gov Identifier: NCT02254265     History of Changes
Other Study ID Numbers: OTX-101-2014-001
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Eye Diseases
Keratoconjunctivitis
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Ophthalmic Solutions