Keratoconjunctivitis SiccaPhase 2/3NCT02254265
Phase 2/3 Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
A Phase 2/3 study testing OTX-101 0.05% and OTX-101 0.09% in people with Keratoconjunctivitis Sicca and Dry Eye Disease, run by Sun Pharmaceutical Industries Limited at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconjunctivitis Sicca, Dry Eye Disease
- What is being tested?
- OTX-101 0.05% and OTX-101 0.09%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 455 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to May 2015
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects age 18 years or older on the date of informed consent.
- All subjects must provide signed written consent prior to participation in any study-related procedures.
- Patient-reported history of KCS for a period of at least 6 months.
- Clinical diagnosis of bilateral KCS supported by OTX-101-2014-001 study assessments.
- 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.
- Global symptom score ≥ 40 at both Screening and Baseline.
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- Corrected Snellen VA of better than 20/200 in each eye.
- Willing to discontinue use of current dry eye therapy (including artificial tears or ocular lubricants) during the study as of the run-in period.
- 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.
Who cannot join
- Use of cyclosporine ophthalmic emulsion 0.05% (Restasis®) within 3 months prior to Screening.
- Previous treatment failure (lack of efficacy) on cyclosporine ophthalmic emulsion 0.05% (Restasis).
- Diagnosed with Sjögren's disease ˃5 years prior to Screening.
- Clinical diagnosis of seasonal and perennial allergic conjunctivitis.
- 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)
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- Antihistamines (including over-the counter (OTC))
- Cholinergics
- Antimuscarinics
- Tricyclic antidepressants
- Phenothiazines
- Retinoids
- Oral omega-3 fatty acids (permitted if dose is stable for 3 months prior to Screening and does not change during the study period)
- 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.
- Current active eye disease other than KCS (i.e., any disease for which topical or systemic ophthalmic medication is necessary).
- History of herpes keratitis.
- 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.
- Diagnosis of chronic uveitis.
- Corneal transplant (e.g., penetrating keratoplasty, lamellar keratoplasty, Descemet's stripping endothelial keratoplasty (DSEK) ).
- 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.
- Cataract surgery within 3 months prior to Screening.
- Non-laser glaucoma surgery at any time; glaucoma laser procedures within 3 months prior to Screening.
- Presence of punctal plugs or past history of permanent punctal occlusion (e.g., cautery).
- Lagophthalmos or clinically significant eyelid margin irregularity of the study eye whether congenital or acquired.
- Presence of conjunctivochalasis (i.e., mechanical blockage of the lower lid punctum by redundant conjunctiva).
- Presence of pterygium in the study eye.
- Unwilling to discontinue use of contact lenses during the duration of the study.
- Preplanned elective surgery or hospitalization during the study period.
- HIV-positive.
- Unable to reliably report symptoms and history.
- Has known hypersensitivity or contraindication to the study medication(s) or their components.
- 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.
- 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.
- Women who are pregnant or breastfeeding.
- 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.
- Previous randomization into this study.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- Keratoconjunctivitis Sicca, Dry Eye Disease
- Being tested
- OTX-101 0.05%, OTX-101 0.09%, Vehicle
- Medical subject headings
- Keratoconjunctivitis Sicca, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTX-101 0.05%Drug
OTX-101 0.05% Ophthalmic Solution
OTX-101 0.09%Drug
OTX-101 0.09% Ophthalmic Solution
VehicleDrug
Vehicle of OTX-101 Ophthalmic Solution
| Study group | Role | What they receive |
|---|---|---|
| OTX-101 0.05% | Experimental | OTX-101 0.05% ophthalmic solution 1 drop in both eyes BID for 84 days Receives: Drug: OTX-101 0.05% |
| OTX-101 0.09% | Experimental | OTX-101 0.09% ophthalmic solution 1 drop in both eyes BID for 84 days Receives: Drug: OTX-101 0.09% |
| Vehicle | Placebo comparator | Vehicle of OTX-101 ophthalmic solution 1 drop in both eyes BID for 84 days Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conjunctival Staining
Mean change from baseline at day 84 for the lissamine green conjunctival staining score in the designated study eye.
The Investigator recorded a score for each area of each eye on a 0 (No punctate stain in zone) to 3 (Densely concentrated micropunctate stain spots) scale
Measured: Baseline to 84 days
Global Symptom Score
Mean change from baseline at day 84 for the global symptom score.
The freuency and severy of dry eye and irritation scores were used to calculate symptom score as follows:
Frequency of dry eye/irritation based on a scale of 0 (rarely) to 100 (all the time) Severity of dryness or irritation based on a scale of 0 (very mildly) to 100 (very severe).
The global symptom score was calculated as the square root of the frequency score times the severity score
Measured: Baseline to 84 days
Secondary outcomes (4)
Tear Film Break up Time (TBUT)
Mean change from baseline in TBUT in the study eye from baseline at Day 84
Measured: Baseline to 84 days
Corneal Staining Score
Mean Change from Baseline in Corneal Staining Score in the Study Eye. Expanded National Eye Institute Scale for Corneal Staining Score was used to grade each of the 5 areas of the cornea on a 0 (No punctate stain in area) to 4 (Severe diffuse (coalescent) macropunctate stain of the area) scale
Measured: Baseline to 84 days
Schirmer's Test
Change from Baseline in Categorized Schirmer's Test Score. Schirmer's test was performed with strips placed in both eyes at the same time. Strips were removed after 5 minutes and the amount of wetting (in mm) was recorded as scores from 1 to 5.
1: < 3 mm, 3 - 6 mm, 7 - 10 mm, 11 - 14 mm, and 5: > 14 mm
Measured: Baseline to 84 days
Patient Satisfaction
Patient satisfaction with treatment score using 5-point scale (1=extremely dissatisfied to 5=extremely satisfied)
Measured: Baseline to 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Keratoconjunctivitis SiccaStudies of the same condition, open and under way.
- More trials run by Sun Pharmaceutical Industries LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 455 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02254265
- Sponsor's protocol ID
- OTX-101-2014-001
- Status last verified
- Nov 2021
- First submitted
- 29 Sep 2014
- Last updated
- 29 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02254265
- Acronym / sponsor ID
- OTX-101-2014-001
- Conditions
- Keratoconjunctivitis Sicca, Dry Eye Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 1 Oct 2014 (estimated)
- Results
- Posted 14 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OTX-101 0.05% | Experimental | Drug: OTX-101 0.05%OTX-101 0.05% ophthalmic solution 1 drop in both eyes BID for 84 days |
| OTX-101 0.09% | Experimental | Drug: OTX-101 0.09%OTX-101 0.09% ophthalmic solution 1 drop in both eyes BID for 84 days |
| Vehicle | Placebo comparator | Drug: VehicleVehicle of OTX-101 ophthalmic solution 1 drop in both eyes BID for 84 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects age 18 years or older on the date of informed consent.
- All subjects must provide signed written consent prior to participation in any study-related procedures.
- Patient-reported history of KCS for a period of at least 6 months.
- Clinical diagnosis of bilateral KCS supported by OTX-101-2014-001 study assessments.
- 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.
Key exclusion criteria (36 listed)
- Use of cyclosporine ophthalmic emulsion 0.05% (Restasis®) within 3 months prior to Screening.
- Previous treatment failure (lack of efficacy) on cyclosporine ophthalmic emulsion 0.05% (Restasis).
- Diagnosed with Sjögren's disease ˃5 years prior to Screening.
- Clinical diagnosis of seasonal and perennial allergic conjunctivitis.
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OTX-101 0.05%OTX-101 0.05% Ophthalmic Solution | Drug | OTX-101 0.05% |
| OTX-101 0.09%OTX-101 0.09% Ophthalmic Solution | Drug | OTX-101 0.09% |
| VehicleVehicle of OTX-101 Ophthalmic Solution | Drug | Vehicle |
Primary outcome
Conjunctival Staining
Time frame: Baseline to 84 days
Mean change from baseline at day 84 for the lissamine green conjunctival staining score in the designated study eye. The Investigator recorded a score for each area of each eye on a 0 (No punctate stain in zone) to 3 (Densely concentrated micropunctate stain spots) scale
Global Symptom Score
Time frame: Baseline to 84 days
Mean change from baseline at day 84 for the global symptom score. The freuency and severy of dry eye and irritation scores were used to calculate symptom score as follows: Frequency of dry eye/irritation based on a scale of 0 (rarely) to 100 (all the time) Severity of dryness or irritation based on a scale of 0 (very mildly) to 100 (very severe). The global symptom score was calculated as the square root of the frequency score times the severity score
4 secondary outcomes
Tear Film Break up Time (TBUT)
Time frame: Baseline to 84 days
Corneal Staining Score
Time frame: Baseline to 84 days
Schirmer's Test
Time frame: Baseline to 84 days
Patient Satisfaction
Time frame: Baseline to 84 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing OTX-101 0.05% and OTX-101 0.09% in people with Keratoconjunctivitis Sicca and Dry Eye Disease, run by Sun Pharmaceutical Industries Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conjunctival Staining (time frame: Baseline to 84 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2022.