Dry Eye Disease (DED)Phase 4NCT07868965
Evaluation of Ophtholic Ultra for Ocular Surface Protection After Cataract Surgery
A Phase 4 study testing Ophtholic Ultra and Standard postoperative therapy without lubricating eye drops in people with Dry Eye Disease (DED), run by Kazakh Eye Research Institute at 1 site in Kazakhstan.
Trial summary
Study of the Effectiveness and Safety of Ophtholic Ultra in Preventing and Correcting Ocular Surface Disturbances After Uncomplicated Cataract Surgery This is a single-center, prospective, randomized, controlled, assessor-masked clinical study evaluating the effectiveness and safety of Ophtholic Ultra, a… Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Dry Eye Disease (DED)
- What is being tested?
- Ophtholic Ultra and Standard postoperative therapy without lubricating eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteKazakhstan
- Study dates
- 24 Aug 2026to 24 Nov 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age 50 to 70 years, inclusive. 2. Age-related cataract with a clinical indication for planned phacoemulsification with intraocular lens implantation. 3. Ability to understand the study information and provide written informed consent. 4. Willingness and ability to comply with the scheduled study visits and study procedures. 5. Ocular surface symptoms, including burning, dryness, tearing, frequent blinking, or foreign body sensation. 6. Corneal transparency sufficient to perform tear film break-up time assessment and fluorescein staining. 7. Uncomplicated cataract surgery completed without complications requiring a change in standard postoperative management.
Who cannot join
- 1. Active infectious or clinically significant inflammatory disease of the ocular surface, eyelids, or lacrimal system. 2. Severe dry eye disease requiring continuous anti-inflammatory, immunomodulatory, or intensive tear replacement therapy. 3. Sjögren syndrome, active systemic autoimmune disease, or another condition expected to substantially affect tear production. 4. Corneal scar, dystrophy, degeneration, marked irregularity, or neurotrophic keratopathy. 5. Significant meibomian gland dysfunction requiring immediate specialized treatment. 6. Uveitis, uncontrolled glaucoma, or previous corneal refractive or other corneal surgery within 12 months before enrollment. 7. Contact lens use within 14 days before the baseline assessment. 8. Use of artificial tears or other topical ophthalmic products affecting the ocular surface that cannot be discontinued for at least 24 hours before baseline testing. 9. Known allergy or hypersensitivity to any component of Ophtholic® Ultra or fluorescein. 10. Any serious medical or cognitive condition that, in the investigator's opinion, makes participation unsafe or prevents reliable study data collection.
- 1. Intraoperative posterior capsule rupture, significant vitreous loss, inability to implant the planned intraocular lens, or another significant intraoperative complication. 2. Need for additional surgical intervention or a change in the standard postoperative eye drop regimen that substantially differs from the study protocol. 3. Withdrawal of informed consent before randomization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Prospective, Randomized, Controlled, Assessor-Blinded Study Evaluating the Efficacy and Safety of Ophtholic Ultra Ophthalmic Lubricating Solution for the Prevention and Correction of Ocular Surface Disorders After Uncomplicated Cataract Surgery
Study of the Effectiveness and Safety of Ophtholic Ultra in Preventing and Correcting Ocular Surface Disturbances After Uncomplicated Cataract Surgery
This is a single-center, prospective, randomized, controlled, assessor-masked clinical study evaluating the effectiveness and safety of Ophtholic Ultra, a preservative-free moisturizing ophthalmic solution containing 0.2% tamarind seed polysaccharide and 0.4% sodium hyaluronate, in patients undergoing uncomplicated cataract surgery.
Read more
Cataract surgery can temporarily affect the ocular surface and tear film, leading to dry eye symptoms, discomfort, epithelial changes, and reduced tear film stability. This study will evaluate whether adding Ophtholic Ultra to standard postoperative treatment can improve ocular surface condition after cataract surgery.
Approximately 60 adults aged 50 to 70 years with age-related cataract will be randomized into three groups. One group will receive standard postoperative treatment plus Ophtholic Ultra for 3 months, the second group will receive standard postoperative treatment plus Ophtholic Ultra for 1 month, and the third group will receive standard postoperative treatment without moisturizing eye drops.
The primary outcome will be the change in tear film break-up time (TBUT) from baseline to Day 90 after cataract surgery. Secondary outcomes will include Schirmer I test results, corneal epithelial staining and defects, visual acuity, patient-reported ocular symptoms and comfort, refractive outcomes, adherence, tolerability, and adverse events.
Participants will be assessed before surgery and on Days 7, 30, and 90 after surgery.
Read the detailed description
This is a single-center, prospective, randomized, parallel-group, controlled, assessor-masked clinical study designed to evaluate the effectiveness and safety of Ophtholic Ultra in the prevention and correction of ocular surface disturbances following uncomplicated phacoemulsification cataract surgery with intraocular lens implantation.
The study will be conducted at the Kazakh Eye Research Institute in Almaty, Republic of Kazakhstan. The study population will consist of adults aged 50 to 70 years with age-related cataract for whom elective cataract surgery is planned.
A total of 60 participants will be randomized in a 1:1:1 ratio into three parallel treatment groups. Each participant will contribute one study eye.
Participants in Group 1 will receive standard postoperative treatment plus Ophtholic Ultra for 3 months. Participants in Group 2 will receive standard postoperative treatment plus Ophtholic Ultra for 1 month. Participants in Group 3 will receive standard postoperative treatment without additional moisturizing eye drops.
Ophtholic Ultra is a preservative-free, multidose moisturizing ophthalmic solution containing 0.2% tamarind seed polysaccharide and 0.4% sodium hyaluronate. In the treatment groups, the study product will be administered as one drop into the operated eye four times daily, beginning on Day -1 before surgery and continuing according to the assigned treatment duration.
The primary objective is to determine whether the addition of Ophtholic® Ultra to standard postoperative treatment improves tear film stability after uncomplicated cataract surgery. The primary outcome measure is the between-group difference in the change in mean tear film break-up time (TBUT), measured from baseline to Day 90 after surgery.
Secondary outcomes include changes in Schirmer I test results, corneal fluorescein staining and epithelial defects, patient-reported ocular symptoms and visual comfort, uncorrected and best-corrected distance visual acuity, refractive outcomes, adherence to treatment, tolerability, and the incidence and characteristics of adverse events.
Participants will undergo a baseline assessment on Day -1 before surgery and postoperative assessments on approximately Day 7, Day 30, and Day 90. Ophthalmic assessments will include slit-lamp examination, visual acuity, refraction, TBUT, fluorescein staining, evaluation and documentation of the corneal epithelium, and Schirmer I testing.
Randomization will be performed using block randomization with a 1:1:1 allocation ratio and variable block sizes. Outcome assessors will be masked to treatment allocation. Participants will be instructed not to disclose their assigned treatment to the assessor and not to bring the study product container to assessment visits.
The study will evaluate the safety and tolerability of the study product throughout the follow-up period. Adverse events will be documented and assessed during study visits.
The expected duration of the overall project is approximately 6 months, including participant recruitment, up to 3 months of follow-up for the last randomized participant, database closure, data analysis, and preparation of the final study report.
- Conditions
- Dry Eye Disease (DED)
- Being tested
- Ophtholic Ultra, Standard postoperative therapy without lubricating eye drops
- Keywords
- Ophtholic Ultra, Sodium hyaluronate, Dry eye, Cataract surgery, Phacoemulsification
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophtholic UltraDrug
Preservative-free multidose ophthalmic lubricating solution containing 0.2% tamarind seed polysaccharide (TS-polysaccharide) and 0.4% sodium hyaluronate. One drop is instilled into the operated eye four times daily from Day -1 through Day 90, in addition to standard postoperative therapy.
Ophtholic UltraDrug
Preservative-free multidose ophthalmic lubricating solution containing 0.2% tamarind seed polysaccharide (TS-polysaccharide) and 0.4% sodium hyaluronate. One drop is instilled into the operated eye four times daily from Day -1 through Day 30, in addition to standard postoperative therapy.
Standard postoperative therapy without lubricating eye dropsOther
Standard postoperative therapy after uncomplicated phacoemulsification with intraocular lens implantation, without the use of lubricating ophthalmic drops.
| Study group | Role | What they receive |
|---|---|---|
| Arm Label: Ophtholic® Ultra - 3 Months | Experimental | Participants will receive standard postoperative treatment after uncomplicated cataract surgery plus Ophtholic® Ultra, one drop in the operated eye four times daily, from Day -1 before surgery through Day 30 after surgery. Receives: Drug: Ophtholic Ultra |
| Arm Label: Ophtholic® Ultra - 1 Month | Experimental | Arm Description:
Participants will receive standard postoperative treatment after uncomplicated cataract surgery plus Ophtholic® Ultra, one drop in the operated eye four times daily, from Day -1 before surgery through Day 30 after surgery. Receives: Drug: Ophtholic Ultra |
| Arm Label: Standard Postoperative Treatment | Active comparator | Arm Description:
Participants will receive standard postoperative treatment after uncomplicated cataract surgery without additional moisturizing eye drops. Receives: Other: Standard postoperative therapy without lubricating eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tear film break-up time (TBUT) from baseline to Day 90 after cataract surgery
The primary outcome is the between-group difference in the change in mean tear film break-up time (TBUT), measured in seconds, from baseline (Day -1 before surgery) to Day 90 after uncomplicated cataract surgery.
Measured: Baseline (Day -1) to Day 90
Secondary outcomes (7)
Change in tear film break-up time (TBUT) from baseline to Day 30
Change in mean tear film break-up time (TBUT), measured in seconds, from baseline (Day -1 before surgery) to Day 30 after cataract surgery, with comparison between treatment groups.
Measured: Baseline (Day -1) to Day 30
Change in Schirmer I test result from baseline
Change in tear production measured by the Schirmer I test, in millimeters, from baseline (Day -1 before surgery) to postoperative Days 7, 30, and 90.
Measured: Baseline (Day -1) to Days 7, 30, and 90
Corneal fluorescein staining and epithelial defect
Change in corneal epithelial condition assessed by fluorescein staining and documentation of epithelial defects after cataract surgery.
Measured: Baseline (Day -1) to Days 7, 30, and 90
Change in patient-reported ocular symptoms and visual comfort
Change in patient-reported ocular surface symptoms, including dryness, burning, foreign body sensation, tearing, frequent blinking, and visual discomfort, following cataract surgery.
Measured: Baseline (Day -1) and Days 7, 30, and 90 after surgery
Change in uncorrected and best-corrected distance visual acuity
Change in uncorrected distance visual acuity and best-corrected distance visual acuity, measured in LogMAR, following cataract surgery.
Measured: Baseline (Day -1) and Days 7, 30, and 90 after surgery
Accuracy of intraocular lens power calculation
Assessment of the effect of Ophtholic® Ultra on the accuracy of intraocular lens power calculation and postoperative refractive outcomes following cataract surgery.
Measured: Baseline (Day -1) and Day 90 after surgery
Incidence of adverse events, treatment tolerability, and adherence
Incidence and characteristics of adverse events, tolerability of Ophtholic® Ultra, and adherence to the assigned treatment regimen during the study period.
Measured: From Day -1 through Day 90 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start24 Aug 2026
- Primary completion24 Oct 2026 (estimated)
- Study completion24 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-center, prospective, randomized, parallel-group, controlled study with three treatment arms. Participants will be randomized in a 1:1:1 ratio to receive standard postoperative treatment plus Ophtholic Ultra for 3 months, standard postoperative treatment plus Ophtholic Ultra for 1 month, or standard postoperative treatment without moisturizing eye drops.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kazakh Eye Research Institute
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868965
- Sponsor's protocol ID
- 15-2026
- Status last verified
- Oct 2026
- First submitted
- 26 Aug 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Prospective, Randomized, Controlled, Assessor-Blinded Study Evaluating the Efficacy and Safety of Ophtholic Ultra Ophthalmic Lubricating Solution for the Prevention and Correction of Ocular Surface Disorders After Uncomplicated Cataract Surgery
- ClinicalTrials.gov ID
- NCT07868965
- Acronym / sponsor ID
- 15-2026
- Conditions
- Dry Eye Disease (DED)
- Keywords
- Ophtholic Ultra, Sodium hyaluronate, Dry eye, Cataract surgery, Phacoemulsification
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kazakh Eye Research InstituteResearch network
- Study start
- 24 Aug 2026 (actual)
- Primary completion
- 24 Oct 2026 (estimated)
- Study completion
- 24 Nov 2026 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study of the Effectiveness and Safety of Ophtholic Ultra in Preventing and Correcting Ocular Surface Disturbances After Uncomplicated Cataract Surgery
This is a single-center, prospective, randomized, controlled, assessor-masked clinical study evaluating the effectiveness and safety of Ophtholic Ultra, a preservative-free moisturizing ophthalmic solution containing 0.2% tamarind seed polysaccharide and 0.4% sodium hyaluronate, in patients undergoing uncomplicated cataract surgery.
Cataract surgery can temporarily affect the ocular surface and tear film, leading to dry eye symptoms, discomfort, epithelial changes, and reduced tear film stability. This study will evaluate whether adding Ophtholic Ultra to standard postoperative treatment can improve ocular surface condition after cataract surgery.
Approximately 60 adults aged 50 to 70 years with age-related cataract will be randomized into three groups. One group will receive standard postoperative treatment plus Ophtholic Ultra for 3 months, the second group will receive standard postoperative treatment plus Ophtholic Ultra for 1 month, and the third group will receive standard postoperative treatment without moisturizing eye drops.
The primary outcome will be the change in tear film break-up time (TBUT) from baseline to Day 90 after cataract surgery. Secondary outcomes will include Schirmer I test results, corneal epithelial staining and defects, visual acuity, patient-reported ocular symptoms and comfort, refractive outcomes, adherence, tolerability, and adverse events.
Participants will be assessed before surgery and on Days 7, 30, and 90 after surgery.
Detailed description
This is a single-center, prospective, randomized, parallel-group, controlled, assessor-masked clinical study designed to evaluate the effectiveness and safety of Ophtholic Ultra in the prevention and correction of ocular surface disturbances following uncomplicated phacoemulsification cataract surgery with intraocular lens implantation.
The study will be conducted at the Kazakh Eye Research Institute in Almaty, Republic of Kazakhstan. The study population will consist of adults aged 50 to 70 years with age-related cataract for whom elective cataract surgery is planned.
A total of 60 participants will be randomized in a 1:1:1 ratio into three parallel treatment groups. Each participant will contribute one study eye.
Participants in Group 1 will receive standard postoperative treatment plus Ophtholic Ultra for 3 months. Participants in Group 2 will receive standard postoperative treatment plus Ophtholic Ultra for 1 month. Participants in Group 3 will receive standard postoperative treatment without additional moisturizing eye drops.
Ophtholic Ultra is a preservative-free, multidose moisturizing ophthalmic solution containing 0.2% tamarind seed polysaccharide and 0.4% sodium hyaluronate. In the treatment groups, the study product will be administered as one drop into the operated eye four times daily, beginning on Day -1 before surgery and continuing according to the assigned treatment duration.
The primary objective is to determine whether the addition of Ophtholic® Ultra to standard postoperative treatment improves tear film stability after uncomplicated cataract surgery. The primary outcome measure is the between-group difference in the change in mean tear film break-up time (TBUT), measured from baseline to Day 90 after surgery.
Secondary outcomes include changes in Schirmer I test results, corneal fluorescein staining and epithelial defects, patient-reported ocular symptoms and visual comfort, uncorrected and best-corrected distance visual acuity, refractive outcomes, adherence to treatment, tolerability, and the incidence and characteristics of adverse events.
Participants will undergo a baseline assessment on Day -1 before surgery and postoperative assessments on approximately Day 7, Day 30, and Day 90. Ophthalmic assessments will include slit-lamp examination, visual acuity, refraction, TBUT, fluorescein staining, evaluation and documentation of the corneal epithelium, and Schirmer I testing.
Randomization will be performed using block randomization with a 1:1:1 allocation ratio and variable block sizes. Outcome assessors will be masked to treatment allocation. Participants will be instructed not to disclose their assigned treatment to the assessor and not to bring the study product container to assessment visits.
The study will evaluate the safety and tolerability of the study product throughout the follow-up period. Adverse events will be documented and assessed during study visits.
The expected duration of the overall project is approximately 6 months, including participant recruitment, up to 3 months of follow-up for the last randomized participant, database closure, data analysis, and preparation of the final study report.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A single-center, prospective, randomized, parallel-group, controlled study with three treatment arms. Participants will be randomized in a 1:1:1 ratio to receive standard postoperative treatment plus Ophtholic Ultra for 3 months, standard postoperative treatment plus Ophtholic Ultra for 1 month, or standard postoperative treatment without moisturizing eye drops.
| Arm | Type | Receives |
|---|---|---|
| Arm Label: Ophtholic® Ultra - 3 Months | Experimental | Drug: Ophtholic UltraParticipants will receive standard postoperative treatment after uncomplicated cataract surgery plus Ophtholic® Ultra, one drop in the operated eye four times daily, from Day -1 before surgery through Day 30 after surgery. |
| Arm Label: Ophtholic® Ultra - 1 Month | Experimental | Drug: Ophtholic UltraArm Description: Participants will receive standard postoperative treatment after uncomplicated cataract surgery plus Ophtholic® Ultra, one drop in the operated eye four times daily, from Day -1 before surgery through Day 30 after surgery. |
| Arm Label: Standard Postoperative Treatment | Active comparator | Other: Standard postoperative therapy without lubricating eye dropsArm Description: Participants will receive standard postoperative treatment after uncomplicated cataract surgery without additional moisturizing eye drops. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Age 50 to 70 years, inclusive. 2. Age-related cataract with a clinical indication for planned phacoemulsification with intraocular lens implantation. 3. Ability to understand the study information and provide written informed consent. 4. Willingness and ability to comply with the scheduled study visits and study procedures. 5. Ocular surface symptoms, including burning, dryness, tearing, frequent blinking, or foreign body sensation. 6. Corneal transparency sufficient to perform tear film break-up time assessment and fluorescein staining. 7. Uncomplicated cataract surgery completed without complications requiring a change in standard postoperative management.
Key exclusion criteria (2 listed)
- 1. Active infectious or clinically significant inflammatory disease of the ocular surface, eyelids, or lacrimal system. 2. Severe dry eye disease requiring continuous anti-inflammatory, immunomodulatory, or intensive tear replacement therapy. 3. Sjögren syndrome, active systemic autoimmune disease, or another condition expected to substantially affect tear production. 4. Corneal scar, dystrophy, degeneration, marked irregularity, or neurotrophic keratopathy. 5. Significant meibomian gland dysfunction requiring immediate specialized treatment. 6. Uveitis, uncontrolled glaucoma, or previous corneal refractive or other corneal surgery within 12 months before enrollment. 7. Contact lens use within 14 days before the baseline assessment. 8. Use of artificial tears or other topical ophthalmic products affecting the ocular surface that cannot be discontinued for at least 24 hours before baseline testing. 9. Known allergy or hypersensitivity to any component of Ophtholic® Ultra or fluorescein. 10. Any serious medical or cognitive condition that, in the investigator's opinion, makes participation unsafe or prevents reliable study data collection.
- 1. Intraoperative posterior capsule rupture, significant vitreous loss, inability to implant the planned intraocular lens, or another significant intraoperative complication. 2. Need for additional surgical intervention or a change in the standard postoperative eye drop regimen that substantially differs from the study protocol. 3. Withdrawal of informed consent before randomization.
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 |
|---|---|---|
| Ophtholic UltraPreservative-free multidose ophthalmic lubricating solution containing 0.2% tamarind seed polysaccharide (TS-polysaccharide) and 0.4% sodium hyaluronate. One drop is instilled into the operated eye four times daily from Day -1 through Day 90, in addition to standard postoperative therapy. | Drug | Arm Label: Ophtholic® Ultra - 3 Months |
| Ophtholic UltraPreservative-free multidose ophthalmic lubricating solution containing 0.2% tamarind seed polysaccharide (TS-polysaccharide) and 0.4% sodium hyaluronate. One drop is instilled into the operated eye four times daily from Day -1 through Day 30, in addition to standard postoperative therapy. | Drug | Arm Label: Ophtholic® Ultra - 1 Month |
| Standard postoperative therapy without lubricating eye dropsStandard postoperative therapy after uncomplicated phacoemulsification with intraocular lens implantation, without the use of lubricating ophthalmic drops. | Other | Arm Label: Standard Postoperative Treatment |
Primary outcome
Change in tear film break-up time (TBUT) from baseline to Day 90 after cataract surgery
Time frame: Baseline (Day -1) to Day 90
The primary outcome is the between-group difference in the change in mean tear film break-up time (TBUT), measured in seconds, from baseline (Day -1 before surgery) to Day 90 after uncomplicated cataract surgery.
7 secondary outcomes
Change in tear film break-up time (TBUT) from baseline to Day 30
Time frame: Baseline (Day -1) to Day 30
Change in Schirmer I test result from baseline
Time frame: Baseline (Day -1) to Days 7, 30, and 90
Corneal fluorescein staining and epithelial defect
Time frame: Baseline (Day -1) to Days 7, 30, and 90
Change in patient-reported ocular symptoms and visual comfort
Time frame: Baseline (Day -1) and Days 7, 30, and 90 after surgery
Change in uncorrected and best-corrected distance visual acuity
Time frame: Baseline (Day -1) and Days 7, 30, and 90 after surgery
Accuracy of intraocular lens power calculation
Time frame: Baseline (Day -1) and Day 90 after surgery
Incidence of adverse events, treatment tolerability, and adherence
Time frame: From Day -1 through Day 90 after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No. We do not plan to share individual participant data with other researchers.
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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 4 study testing Ophtholic Ultra and Standard postoperative therapy without lubricating eye drops in people with Dry Eye Disease (DED), run by Kazakh Eye Research Institute at 1 site in Kazakhstan.
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 1 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. 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 Kazakhstan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Change in tear film break-up time (TBUT) from baseline to Day 90 after cataract surgery (time frame: Baseline (Day -1) to Day 90). 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 9 Oct 2026.