NCT03088605 is a Phase 2 clinical trial of TOP1630 Ophthalmic Solution in Dry Eye Syndrome, sponsored by ORA, Inc..

Who is sponsoring NCT03088605?

NCT03088605 is sponsored by ORA, Inc..

What drugs are being tested in NCT03088605?

Interventions in NCT03088605: TOP1630 Ophthalmic Solution, Placebo to TOP1630 Ophthalmic Solution.

What condition does NCT03088605 study?

NCT03088605 studies Dry Eye Syndrome.

Is NCT03088605 still recruiting?

NCT03088605 is currently completed. Last updated 14 February 2024.

Are results published for NCT03088605?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-02-14 · How we verify

NCT03088605

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Efficacy of TOP1630 for Dry Eye Syndrome

Completed Phase 2 Results posted Last updated 14 February 2024

What this trial tests

Phase 2 trial testing TOP1630 Ophthalmic Solution in Dry Eye Syndrome in 69 participants. Completed in 15 June 2017.

Timeline

20 February 2017

Primary endpoint
15 June 2017

15 June 2017

Quick facts

Lead sponsor	ORA, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	69
Start date	20 February 2017
Primary completion	15 June 2017
Estimated completion	15 June 2017
Sites	1 location across United States

Drugs / interventions tested

TOP1630 Ophthalmic Solution — full drug profile →
Placebo to TOP1630 Ophthalmic Solution — full drug profile →

Conditions studied

Dry Eye Syndrome — all drugs for Dry Eye Syndrome →

Sponsor

ORA, Inc. — full company profile →

Who can join

18 and older, any sex, with Dry Eye Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Visual Acuity Primary · Part 1: 12 days time frame; Part 2: 35 days time frame

Visual Acuity will be measured using the EDTRS chart to assess changes from baseline

Part 1

Group	Value	95% CI
Active	0.05	± 0.143
Placebo	-0.09	± 0.156

Part 2

Group	Value	95% CI
Active	0.017	± 0.1163
Placebo	0.075	± 0.1242

Slit-lamp Biomicroscopy Primary · Part 1: 12 days time frame; Part 2: 35 days time frame

Slit lamp biomicroscopy exams will be performed to assess any changes from baseline; outcome measure is number of patients with no abnormalities

Part 1

Group	Value	95% CI
Active	6
Placebo	2

Part 2

Group	Value	95% CI
Active	31
Placebo	30

Drop Comfort Assessment Primary · Part 1: 12 days time frame

The comfort of the eye drop will be performed to assess changes from baseline. Drop Comfort Assessment Scale; 0-10; 0 being very comfortable and 10 being very uncomfortable

Group	Value	95% CI
Active	0.71	± 0.846
Placebo	1.38	± 0.495

Intraocular Pressure Primary · Part 1: 12 days time frame; Part 2: 35 days time frame

a non-contact tonometer will be used to perform IOP to assess changes from baseline.

Part 1

Group	Value	95% CI
Active	12.3	± 1.03
Placebo	15.5	± 0.71

Part 2

Group	Value	95% CI
Active	12.4	± 1.75
Placebo	12.8	± 2.54

Corneal Sensitivity Primary · Part 1: 12 days time frame; Part 2: 35 days time frame

The aesthesiometer will be used to perform corneal sensitivity to assess changes from baseline. Corneal Sensitivity Scale. Scale of 0-6

Group	Value	95% CI
Active	59.8	± 0.91
Placebo	59.4	± 1.74

Undilated Fundoscopy Primary · Part 2: 35 days time frame

Non-Contact undilated fundoscopy exam will be performed to assess changes from baseline; outcome measure is number of patients with no abnormalities

Group	Value	95% CI
Active	31
Placebo	30

Vital Signs - Pulse Primary · Part 1: 12 days time frame; Part 2: 35 days time frame

Changes in vital signs is performed to assess changes from baseline

Part 1

Group	Value	95% CI
Active	64.3	± 9.09
Placebo	75.0	± 4.24

Part 2

Group	Value	95% CI
Active	68.8	± 10.55
Placebo	70.5	± 15.66

Vital Signs - O2 Saturation Primary · Part 1: 12 days time frame; Part 2: 35 days time frame

Changes in vital signs is performed to assess changes from baseline

Part 1

Group	Value	95% CI
Active	95.8	± 1.94
Placebo	97.0	± 1.41

Part 2

Group	Value	95% CI
Active	96.3	± 1.75
Placebo	95.7	± 1.66

Vital Signs - Systolic Blood Pressure Primary · Part 1: 12 days time frame; Part 2: 35 days time frame

Changes in vital signs is performed to assess changes from baseline

Part 1

Group	Value	95% CI
Active	128.0	± 29.32
Placebo	148.5	± 3.54

Part 2

Group	Value	95% CI
Active	120.9	± 15.97
Placebo	128.2	± 17.10

Vital Signs - Diastolic Blood Pressure Primary · Part 1: 12 days time frame; Part 2: 35 days time frame

Changes in vital signs is performed to assess changes from baseline

Part 1

Group	Value	95% CI
Active	72.7	± 8.69
Placebo	89.5	± 9.19

Part 2

Group	Value	95% CI
Active	71.2	± 9.53
Placebo	72.0	± 9.39

Ocular Discomfort Secondary · Part 2: 35 days time frame

Ocular discomfort Scale severity assessment (0-4 scale where 0 = none and 4 = constant)

Group	Value	95% CI
Active	3.5	± 0.78
Placebo	3.9	± 0.31

Dry Eye Symptoms Secondary · Part 2: 35 days time frame

Dry eye syndrome symptom assessment Scale (grittiness) (0-5 scale where 0 = none and 5 = worst)

Group	Value	95% CI
Active	1.7	± 1.42
Placebo	2.8	± 1.38

Adverse events — posted to ClinicalTrials.gov

Time frame: 4 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Active

Serious: 0/37 (0%)

Deaths: 0/37

Placebo

Serious: 0/32 (0%)

Deaths: 0/32

Other adverse events (10 terms — click to expand)

Reaction	System	Active	Placebo
Instillation site pain	General disorders	—	—
Visual acuity reduced	Eye disorders	—	—
Eye Discharge	Eye disorders	—	—
Vision blurred	Eye disorders	—	—
Vitreous floaters	Eye disorders	—	—
Ocular itching	Eye disorders	—	—
Instillation site discomfort	General disorders	—	—
Procedural pain	Injury, poisoning and procedural complications	—	—
Common cold	Respiratory, thoracic and mediastinal disorders	—	—
Headache	Nervous system disorders	—	—

Data from ClinicalTrials.gov NCT03088605 adverse events section.

Sponsor's own description

In subjects with Dry Eye Syndrome: The primary objective of this study is to compare the safety and tolerability of TOP1630 Ophthalmic Solution to placebo. The secondary objectives are to compare the efficacy of TOP1630 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye syndrome.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

A phase 2 randomized, double-masked, placebo-controlled study of novel nonsystemic kinase inhibitor TOP1630 for the treatment of dry eye disease.
Taylor M, Ousler G, Torkildsen G, Walshe C, et al · · 2019 · cited 13× · PMID 30858682 · DOI 10.2147/opth.s189039

Verify or expand the search:

Other recruiting trials for Dry Eye Syndrome

Currently open trials in the same condition.

NCT07295691 — Autologous Serum Eye Drops in Dry Eye Syndrome · NA · recruiting
NCT06914232 — Efficacy of Warm Compress Therapy in Enhancing Tear Film Quality and Reducing Postoperative DES · NA · active not recruiting
NCT06913556 — Comparing Effect of Hylorunic Acid and Lipid-coated Carbomer Gel on Dry Eyes After Phacoemulsification in DP · NA · active not recruiting

Other ORA, Inc. trials

Trials by the same sponsor.

NCT07068958 — A Study Evaluating the Efficacy and Safety of RCI001 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye · Phase 2 · not yet recruiting
NCT06178679 — Safety and Efficacy of ST-100 (Vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution in Subjects Diagnosed Wit · Phase 3 · unknown
NCT04268069 — Efficacy and Safety of PL9643 Ophthalmic Solution in Subjects With Dry Eye · Phase 2 · completed
NCT03320434 — Study Evaluating the Efficacy and Safety of PRT-2761 for the Treatment of Acute and Chronic Allergic Conjunctivitis · Phase 2 · completed
NCT03275753 — Visual Function Tests in Age-related Macular Degeneration · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03088605 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by ORA, Inc.
Last refreshed: 14 February 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03088605.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03088605

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Dry Eye Syndrome

Other ORA, Inc. trials

Verify against primary sources